#form 42 for registration for importing cosmetics

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CDSCO Import License for Drugs & Devices – Apply via Agile Regulatory

Importing drugs or medical devices into India? You’ll need a CDSCO import license. Agile Regulatory helps you apply for CDSCO Form 10, MD-14, and other relevant permissions smoothly. We take care of dossier compilation, legal representation, and coordination with CDSCO authorities to speed up your approval process. 

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How Regulatory Reporting Can Help in Medical Device Introduction in India

The Indian medical device market is growing at an unprecedented rate. Currently valued at approximately USD 12 billion, it is projected to reach USD 50 billion by 2030. This growth presents a lucrative opportunity for manufacturers and importers to introduce their medical devices in India.

However, entering this market requires careful navigation through stringent regulatory approval processes. To ensure a successful launch, having a robust plan for regulatory reporting is crucial.

In this blog, we will explain how regulatory reporting can assist in introducing a medical device in the Indian market.

Governing Body for Medical Device Registration in India

The Central Drugs Standard Control Organization (CDSCO) serves as the National Regulatory Authority of India, overseeing medical device registration and ensuring compliance with regulatory standards.

Who Can Apply for Medical Device Registration Under CDSCO?

The following parties are eligible to register medical devices with CDSCO:

Manufacturers with a registered office in India

Authorized representatives of the manufacturer

Subsidiaries of the manufacturer

Importers

Domestic manufacturers

For more information, refer to our blog, "7 Key Steps In CDSCO Medical Device Registration: Easy Guide."

What is Regulatory Reporting?

Regulatory reporting involves the systematic preparation and submission of documentation required for gaining approval to launch medical devices in the Indian market. This process is key to ensuring compliance with CDSCO regulations and other local standards.

Importance of Regulatory Reporting

Effective regulatory reporting facilitates:

Timely Market Access: Accelerating product approvals for quicker entry into the market.

Risk Minimization: Identifying and mitigating potential regulatory risks.

Regulatory Compliance: Ensuring adherence to evolving standards and regulations.

Resource Optimization: Enabling efficient allocation of resources during the approval process.

Key Components of Regulatory Reporting

A comprehensive regulatory reporting strategy consists of the following elements:

Product Type Identification Determine whether the product falls under medical devices, In Vitro Diagnostics (IVDs), cosmetics, or drugs, as each has distinct regulatory frameworks.

Risk Classification Establish the risk class of the device, as this impacts the regulatory requirements and approval pathway.

Existing Predicate or Similar Device Identify if a similar device exists in India. A predicate device demonstrates substantial equivalence and simplifies the approval process. If no predicate exists, additional steps are required. For more details, refer to our blog, "CDSCO Approval Process for Medical Devices Without Predicate in India."

Regulatory Status in Other Countries Leverage approvals from other countries to demonstrate safety, efficacy, and quality. This may also qualify the device for certain waivers, such as clinical trial exemptions.

Warehouse Availability & Registration Ensure that a warehouse is available and registered (Form MD-42). This is a mandatory prerequisite for introducing a medical device in India. Refer to our blog, "Registration Certificate for Sale," for further guidance.

Conclusion

The Indian medical device market presents tremendous opportunities but also demands adherence to stringent regulatory requirements. Comprehensive regulatory reporting ensures a clear pathway for product approval, minimizing delays and ensuring compliance.

Regulatory Solutions India (RSI) offers over 12 years of expertise in regulatory reporting, guiding companies through the complex process of medical device, IVD, cosmetics, and drug registration. Contact us today to streamline your product’s journey into India’s rapidly growing healthcare market. Partnering with RSI will help you bring your innovations to patients while ensuring compliance and commercial success.

[corpseed22]

Understanding the Latest Requirements: Form 42 and Form 43 for the Import Cosmetics in India

In the dynamic landscape of global trade, the Indian cosmetics market stands out as a lucrative opportunity for businesses seeking expansion. However, entering this market requires careful navigation of regulatory requirements, particularly in terms of form submission. Two critical documents, Form 42 and Form 43, play a pivotal role in facilitating the importation of cosmetics into India. In this article, we'll delve into the latest requirements surrounding these forms and their significance for importers.

The Importance of Form 42 and Form 43

Form 42 and Form 43 for the import of cosmetics in India are mandated by the Drug Controller General of India (DCGI) under the provisions of the Drugs and Cosmetics Act, 1940, and the rules framed thereunder. These forms serve as crucial instruments for ensuring the safety, quality, and compliance of imported cosmetics entering the Indian market.

Form 42: Import of Cosmetics

Form 42 is a document prescribed for the import of cosmetics into India. It is essentially an application form that importers need to submit to the DCGI for obtaining authorization prior to importing cosmetics. The form includes essential details such as the name and address of the importer, details of the manufacturer, product information, and compliance declarations.

Form 43: Test License for Import of Cosmetics

Form 43, on the other hand, pertains to the issuance of a test license for the import of cosmetics. Importers are required to submit this form along with the requisite fees to the DCGI for obtaining a test license. The test license allows importers to import a small quantity of cosmetics for testing and analysis purposes before commercial distribution.

Latest Requirements and Updates

In recent years, the Indian regulatory landscape governing cosmetics importation has witnessed notable updates and amendments. Importers must stay abreast of these changes to ensure compliance with the latest requirements. Key considerations include:

Product Registration: Certain categories of cosmetics may require product registration with the Central Drugs Standard Control Organization (CDSCO) before importation. Importers must verify whether their products fall under the purview of mandatory registration.

Labeling and Packaging Requirements: Compliance with labeling and packaging regulations is paramount. Cosmetics intended for importation into India must adhere to specific labeling requirements, including the declaration of ingredients, usage instructions, and safety warnings in the prescribed format.

Good Manufacturing Practices (GMP): Importers are expected to source cosmetics from manufacturers adhering to Good Manufacturing Practices (GMP) to ensure product quality and safety.

Conclusion

In conclusion, navigating the regulatory framework for importing cosmetics into India requires a thorough understanding of the latest requirements, including Form 42 and Form 43. Importers must diligently comply with these requirements to facilitate smooth and legally compliant importation processes. By staying informed and proactive, businesses can seize the vast opportunities offered by the thriving Indian cosmetics market while upholding the highest standards of quality and safety.

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[meeraoperon]

CDSCO Import License for Medical Devices

Medical Device Import License:

Applicable when we have to import medical devices from other countries to India. However they need to be classified according to CDSCO notified devices list. CDSCO has complete procedure for granting license for medical device imported in the countries.

Application for grant of import license

An authorized agent (who must have wholesale license for local distribution) having license to manufacture for sale or distribution or wholesale license for sale or distribution under these rules, shall make an application for grant of import license for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a license.

Where the Central Licensing Authority, has reason to believe that the quality of the medical device is compromised, and decides to subject to its evaluation, tests or evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.

After examining the documents along with the application on the basis of the inspection report, if the inspection has been done by the Central Licensing Authority can be satisfied, grant license in Form MD-15 may reject this application for this reasons shall be recorded in writing within the time of nine months from the date of the application.

In the process of rejection the applicant can make an appeal to the Central Government within the time of forty five days and that the Government, may after the enquiry in this matter pass order in relation there within the time of ninety days from the date of appeal.

Operon Strategist assists pharma or medical device distributors and medical device wholesalers in India to procure CDSCO import license. An Import license is issued for import of medical device from other country to India. Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit.

Medical Devices: - A medical device is a device or a equipment used for medical purposes. A medical device helps patients by health care providers, to diagnose and treat patients and help them overcome their sickness or disease. Important potential for dangers are basic when using a medical device for purposes and hence medical device must be proved safe and effectual with reasonable assurance before regulating government allows marketing of the device in country. Medical devices differ in both their purposeful use and indications for use. For example range from simple new risk devices such as Thermometer, medical gloves, bedpans to complex high risk devices which are implanted and support life.

Medical Device Registration: - Medical Devices entering India must be in compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, co-ordination of the activity of State Drug Control Organizations.

The Government of India has issued a Gazette Notification G.S.R 426(E) dated 19th may 2010 for amending the Drugs and Cosmetics Rules, 1945 providing for registration of import of cosmetics into the country. The above provision was to come into effect from 1st April, 2011. But in the view of the various possible difficulties apprehended by the stakeholders, its implementation has been deferred till the 31st March, 2013.

CDSCO Overview and History:-

Central Drugs Standard Control Organization is the main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices is submitted to Central Licensing Authority, where the (DCGI) Drug Controller General of India takes the responsibility for approval of Manufacturing, Registration, Import and Sale of Medical Devices in India.

Authority of CDSCO

Below functions are undertaked for CDSCO for Medical Device and Cosmetics

Import of all Classes of medical devices

Manufacture all Classes of medical devices

Clinical investigation and approval of investigating medical devices

Clinical performance evaluation and approval of new in vitro diagnostic medical devices

Co-ordination with the state licensing authority

Manufacture for sale or distribution of Class A or Class B medical devices

Sale, Stock, exhibit, or offer of sale or distribution of medical devices of all classes.

The central licensing authority, may with the prior approval of the central government by an order in writing, delegate all or any of its powers to any other officer of the Central Drugs Standard Control Organization.

The Central Government may, by notification designate such institute firm or a Government aided or Government organization which fulfills the criteria specified from time to time by the government as the National Accreditation Body. Provided that the National Accreditation Board for certification Bodies under the Quality Council of India, registered under the Societies Registration Act, 1860 (21 of 1860) set up by the ministry of commerce and industry in the Government of India shall act as the National Accreditation Body for the purposes of accrediting Notified Bodies referred to in rule 13, till such time any other body for the purposes is notified, with immediate effect.

Notified Body working with State FDAs

The Notified Body is competent to carry out the audit of manufacturing sites of Class A and Class B medical devices to verify conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority and Central Licensing Authority.

Medical Device manufacturing License

Test license

The test license is the 1st step for the manufacturing license which is mandatory. Form no 11 or Test license is granted for importing small quantities of drugs or medical devices, which is otherwise banned under the section 10 of the Drugs and Cosmetics Acts and Rules, 1945 in the purpose of analysis, testing and examination. Basic details of medical devices are required in this table;

Validity of license

A License granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless it has been cancelled or surrendered, provided by the authorized agent deposits the license retention fee with the Central Licensing Authority as specified in the second schedule for each overseas manufacturing site and for each licensed medical device after completion of every five years from the date of its issue: Provided that the Central Licensing Authority may permit to deposit the license retention fee after due date but before expiry of ninety days with a late fee calculated at the rate of two per cent. per mensem Provided further that if the licensee fails to deposit the license retention fee within the above stipulated period, the license shall be deemed to have been cancelled.

Application for manufacture for sale or for distribution of Class A or Class B medical device.

Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostics medical device shall make an application for grant of license or loan license to manufacturer for sale or for distribution to the State licensing Authority.

The applicant under sub-rule (1) shall be made through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-3 for License or in Form MD-4 for loan license accompanied with a fee, as specified in Part II of the fourth schedule.

Class A and B application is done under the CDSCO portal.

The required audit for such manufacturing site is required by the registered Notified Body.

Application for manufacturing Class C and Class D medical devices

An application shall be made to the Central Licensing Authority through an identified online portal of the Central Government for License to manufacture for sale and distribution.

The Central Licensing Authority may, where required, avail the services of a Notified Body referred to in sub-rule (4) of rule 13 for inspecting the manufacturing site of Class C and Class D medical devices.

Manufacturing License Application

Documents Requirements

ISO 13485 certificate

Site master file

Device master file

Test license

Cosmetic Import License

Manufacturing License Application

Although the law does not require cosmetics products and ingredients except for the color and additives, which has to be approved by the FDA before they go into the market. No cosmetics shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22.

Form and manner of application for registration certificate:

An application for issue of a Registration Certificate for cosmetics intended to be imported into India shall be done in the Form No-42 either by the manufacturer himself or by his authorized agent or the importer in India or by the subsidiary in India, authorized by the manufacturer and shall be accompanied by a fee of two hundred and fifty US Dollars or its equivalent to the Indian rupees for each brand of cosmetic.

Grant of registration certificate

On receipt of an application for Registration Certificate in the form and manner specified in rule 129A, the licensing authority shall, if satisfied, issued a Registration Certification in form 43 subject to the conditions of the registration certificates in form 43

If the application is completed in all respects and information mentioned in the schedule, the licensing authority shall, within six months from the date of receipt of an application, issue such Registration Certification and in such exceptional situations and for no reasons to be recorded in the writing the Registration Certificate may be issued within such extended period, not exceeding for three months as the licensing authority may deem fit.

The Duration of Registration Certificate

The duration for the Registration of certificate, unless sooner suspended or cancelled, shall be valid for a period of Three years from the date of its issue.

Operon strategist’s expertise

Operon strategist is the leading medical device regulatory consulting company; we provide regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications.

Competencies

We reduce our client’s costs and efforts.

We have Strong personal relations with regulated bodies.

We also have Strong and experienced regulatory team.

We represent on behalf of our client’s for Audits of FDA, ISO, & CE.

Competent Technical staff.

Case Study

Avoiding market access delay due to incorrect product classification

A start-up company (with the help of two innovative physicians) developed a tool that provides a safer, more effective way to alleviate a common orthopedic condition. Although early funding came at a cadence that kept progress moving steadily ahead, rounds for managing the entire life cycle to reach commercial distribution were relatively small. But by correctly classifying the device, time to market was minimized.

The Client’s Challenge

The company had no staff that was acquainted with FDA regulations regarding medical device submissions. It initially assumed that, because of the invasive nature of the product, it had to be a Class II device and would therefore require a 510(k).

Operon Strategist’s Approach

Our company Operon Strategist took the time to integrate into the client’s team in order to identify both the technology and business goals. Starting with the critical questions “why” and “how”, Operon also identified a new strategic approach. First, a Class I predicate was identified and a regulatory strategy was developed. Then, a pre-submission package was prepared to allay regulatory strategy concerns from the board of directors and to demonstrate the feasibility of the concept. After a successful FDA interaction, Operon’s consultants further helped manage an iterative and interactive pathway to complete the design process and design validation. The final step was to design a CFR820 compliant quality system addressing the unique needs of supplier management and complaint handling in a virtual company. This approach kept the overhead burden down while at the same time providing a solid launch pad for future growth.

The Outcome

The client was able to enter market faster and with less expense by using a regulatory strategy and data supporting registration and then listing as a Class I device. While typical concept-to-bedside timelines for devices can vary anywhere from 18 month to 8 years, by carefully examining the requirements for Class I devices, the Company was able to gain FDA agreement that the device was a Class I, requiring only general controls. This strategy shaved years off the development pathway and successfully avoided many pre-clinical and clinical costs. From concept to market the product was in the hands of physicians within two and a half years.  At the same time, the company’s quality control system and selection of vendors has assured full compliance with FDA design controls and all regulatory responsibilities.

Read More - CDSCO Import

License

Contact details –Phone no -  9325283428Mail  -

dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

   1.    

Medical Device Manufacturing

   2.    

CDSCO Registration

   3.    

FDA 510 k clearance

   4.    

Continuous Improvement Program

   5.    

Design Control Requirements

   6.    

QMS Certification Services

   7.    

Manufacturing Plant Layout Design

   8.    

Primary Packaging Consultant

   9.    

CE Marking Consultant

 10.

Combination Product

11.

Medical Device Design And Development

 12.

Clean Room Design Consultant

13.

ISO 13485 Certification

14.

ISO 15378 certification

15.

Medical Device Process Validation

16.

21 cfr part 820

17.

21 cfr part 210 and 211

18.

DMF submission

19.

CAPA Management

20.

TURNKEY PROJECT CONSULTANT

21.

Manufacturing Site Conceptualization

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Stage Credit Card || Stage Credit Card Login || Stage Credit Card Payment Process [Steps by Steps 2019]

Stage Credit Card

Stage stores are a known department company in the US and are one of the top shopping places for the people. It has 650 stores in over 42 states in the country under Bealls, Palais Royal, Peebles, Stage, Gordmans, and Goody's company. They provide a range of products to you, such as clothes, accessories, cosmetics, home décor, footwear and more. Apart from that, they have some exclusive brands under their belly, such as Signature Studio, Rustic Blue, Valerie Stevens and many more.   However, there is more to the Stage stores than what meets the eye. They provide you the Stage credit card to make your life easier while shopping at the stage stores. Stage credit card payment is more than easy and can be processed in many ways, which you will see later in this article. And unlike other credit cards, Stage credit card payment will not make your life a nightmare. If you prefer shopping at the Stage stores or Stage e-commerce website, you must go for the Stage credit card as it will provide you plenty of benefits and rewards. Issued by the Comenity bank, you can use the Stage credit card to shop at Stage, Bealls, Goody's, Pebbles and Palais Royal. There are two types of Stage credit card, the Stage credit card, and the Platinum Stage credit card. Read on to know more about them.   Approval and Requirements for the Stage Credit Card With easy Stage credit card payment and amazing benefits, you must be thinking about Stage credit card application for one of these credit cards. However, before you start applying for one of them, you must know the requirements to get the Stage credit card. Have a look below to know about these requirements. Should be 18 years old or more. Must be a citizen of the USA Should have a Social Security Number Must have a residential address Should have an email address Must have a valid source of income If you meet these requirements then you can easily apply for the Stage credit card and carry on with Stage credit card login to make your Stage credit card payment on time. You can even download the Stage credit card app for the same purpose.   Benefits and Rewards of the Stage Credit Card You get thunder of benefits with your Stage credit card, once you start using it. Although it is a store card, you can earn double points every time you shop with it at one of the stores. And once you earn 100 points, you can exchange them for a $5 payback reward. As a Stage credit cardholder, you can make double of the double points every year, which makes it 4X! It can be used at any Stage store or online and making the Stage credit card payment is quite easy with the Stage credit card app. You just have to Stage credit card sign in to make the Stage credit card bill pay. You get rewarded on any items you buy, perfumes, apparel, kid's clothes, or makeup. If you have a Platinum Stage credit card, you will be provided with a $20 birthday gift and a Christmas gift as well. Other cardholders receive a $10 birthday reward. For every $1 you spend, you receive four points that you can redeem at the Stage's community of stores like Peebles and Bealls.   Registration of the Stage Credit Card Once you have received your Stage credit card, we're sure you won't be thinking of Stage credit card payment or the Stage credit card offers. All you'll be thinking about is trying it out at the Stage store on The Stage website. However, we'll have to stop you. The first step that you need to do after receiving the Stage credit card is to register it in the Stage credit card website. If you are unsure about how to do so, we have a few steps to help you out. First, open up the Stage credit card You will see the Stage credit card sign in the window on the left-hand side. Below the sign-in link, there will be an option saying Register for Online Access. Tap on that option. The next page will open up the registering form for you. It will ask you certain details, such as your Stage credit card account number, your Postal code, Identification type and the last digits of your Social Security Number. Enter the asked details and you will soon become a registered member of the Stage credit card Registering into the account is important as without it you won't be able to Stage credit card login and make Stage credit card payment. If you want to use your card you need to register it first and only then you will be able to make Stage credit card online payment.   Applying for the Stage Credit Card If you have finally decided to opt for the Stage credit card, then don't waste any more time in sending your Stage credit card application for it. However, if you don't know how to apply for it, we have your back. Just have a look at the below steps to fill your Stage credit card application. Once you have opened the Stage credit card website and clicked on Apply Now, it will open up a Stage Credit card application form asking your personal information. It will ask your name, Social Security Number, Date of birth and annual income. Along with that, it will also ask your contact information, such as your home address, email address and phone number. Fill in the next forms that follow up and submit your Stage credit card application and just wait for its approval.   Stage Credit Card Login Process Although Stage credit card login is quite easy when it comes to accessing your Stage credit card account, some cardholders still find it troublesome and get confused. If you are one of those, we have a series of steps to help you out. Have a look. Open up the homepage of the Stage credit card website and you'll find the Stage credit card sign in the window on the left-hand side.  

Stage Credit Card Login The Stage credit card login window or the Stage credit card sign-in window will ask you your Username and password.     2. Enter the two details and click on the Sign In link.     3. You will be able to access your account and make Stage credit card payment or check your balance, as per your wish.   Forgot Password or Forgot User ID for Stage Credit Card   Recover Your Account When You Forget Your Password Forgetting a password is not new and a lot of people do so, especially when they have to make their Stage credit card payment. The Stage credit card offers you a fine way of recovering your account on your own when you forget your password. Have a look at the following steps to recover your account when you lose your password. Now that you have tried numerous passwords and none of them are working in the Stage credit card login window, you will find a link below the Sign-in option saying Forgot your username or password. Click on that link. 2. The next page will open up with a form ready for you and ask you your account number or username, Postal code, identification type and the last 4 digits of your Social Security Number. 3. Enter the asked details and click on the Find my Account link. 4. You will soon be resetting your password, which we hope you don't forget   Recover Your Account if You Forget Your Username Although forgetting your username is not usual, for if you don't Stage credit card sign in too often, then there are chances that you may forget it. However, fret not, even if you have forgotten your Stage credit card username and need to make a Stage credit card payment, it won't take you long to access your account. All you have to do is follow these given steps.   Once you have tried a few usernames and haven't gotten anywhere, find the Forgot Your Username or Password link below in the Stage credit card login window and click on it. The next page will open up a form to confirm your identification. It will ask your account number, Postal code, identification type and the last 4 digits of your Social Security Number. Enter the asked details and click on Find my Account. You will soon get your username and will be able to access your account to make your Stage credit card payment. However, Stage credit card bill payments can be made through other methods as well.   Stage Credit Card Payment Process When it comes to the Stage credit card payment, you can easily do it online, without going through any hassles. First, you need to Stage credit card login to the stage credit card website to access your account and then click on the payment link to make the Stage credit card online payment. This way you will be able to do your Stage credit card bill pay without posting any cheques or money orders, or going to the store to make the Stage credit card payment.   Stage Credit Card App You won't ever miss your Stage credit card payment if you download Prism, a Stage credit card app. It is one free app which helps you track and pay your bills. It sends you to push notifications which assists you as a reminder for Stage credit card bill pay and you never forget your Stage credit card payment. Apart from that, it even tells you how much you owe and when you have to pay it. So you no longer have to keep a diary and keep a note of it. Along with that, you can Stage credit card sign in to pay your bills faster than usual.   Stage Credit Card Customer Support Since the time you sent your Stage credit card application to the time you start shopping with your Stage credit card, you will be needing the help of customer support, whether to check the status of your Stage credit card application or to report a complaint. Keeping this in mind, we have some contact information which will be useful for Stage credit cardholders. Have a look. Customer Care: 1-800-315-7260 Timings: Monday to Saturday from 8 AM to 11 PM Customer Care Address: Comenity Bank PO Box 182273 Columbus, OH 43218-2273   Deactivating Stage Credit Card While there was a time when you sent your Stage credit card application, if today you want to deactivate or cancel your Stage credit card for some reason, we are no one to stop you. Have a look at following steps to deactivate your Stage credit card. Before you consider canceling your Stage credit card, ensure that you have made all of your Stage credit card payment. If not, you can Stage credit card login and make a Stage credit card online payment. Now, to cancel your Stage credit card, call the customer care and tell them your intentions. They might try to change your mind but if you're clear about deactivating your account, tell the representative firmly. While the customer care representative will tell you about different Stage credit card offers, be firm and say no. While your credit card will be canceled, you will have to write down a confirmation letter and mail it to the Stage store about the cancellation.   User Reviews of Stage Credit Card Still making up your mind about the Stage credit card? We have a few user reviews that you must have a look at. I got my card within 2 weeks and went for a shopping spree with my girls! It was the best thing I ever did! This stage credit card is awesome. I got 1000 points already making the payments is so easy peasy. I would recommend everyone to get this card as it's the best one. Capital one credit card also I had and it never got me anywhere. But stage card is really good and I'm really liking it.   2. My mom loves to shop at the stage so I got her one. Best thing I ever did! She's getting rewarded every time she shops and is redeeming them. She mostly buys useful stuff, nothing useless and pays on time so I'm happy she did well with this card. She has even started shopping at Peebles where she never used to go. Good for her!   3. What can I say? Stage credit card is one store card which is much better than the bank cards. Even though you can use them at other places, you save a lot. I'm in love with the stage and buy a lot of stuff from there so I got the card but I never knew that I would end up with so many benefits. This is a really great thing I did as I'm getting so many points and my $10 birthday gift was a nice thing by stage. I have never used any other credit card and I m gonna stick to this one till I'm breathing.   Other Credit Cards: Chase Credit Card Lowes Credit Card Capital One Credit Card Bank Of America Credit Card Citi Bank Credit Card JCPenney Credit Card Payment Old Navy Credit Card Login Wayfair Credit Card Login TJ Maxx Credit Card Login Cerulean Credit Card Big Lots Credit Card Newegg Credit Card Best Buy Credit Card Payment BDO Credit Card                                                                           Click Here for Home Read the full article

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How Do I Send a DMCA Take Down Notice?

A DMCA take-down notice is an easy and relatively inexpensive way to have your copyright protected materials removed from a website hosting company servers, or a search index on Yahoo, Google, or Bing. The first thing you need to know about how to send a DMCA notice is that you must be the copyright owner in order to send the notice. The copyright owner is typically the person who put their fingers to the keyboard, their finger to the click button on the camera, or their pen to paper. The person who is the author of the work is most often the copyright owner. Sometimes the copyright owner will license or sign their interest to an employer or third party which may then have the impact of transferring the copyright to someone who is not the author.

The next thing you need to understand about how to send a DMCA take-down notice is who to send it to. As noted above, any third party who is a service provider with a DMCA copyright policy is potentially a target for a DMCA notice letter. So, for instance, the company hosting the website is often the primary DMCA notice target. People don’t realize they can also send a DMCA notice to Google, Yahoo, and Bing in order to have their materials removed from the search index. That often gets the job done since the infringing material doesn’t come back on search.

You must strictly follow the DMCA take-down policy and rules set forth by the third party provider in order to successfully remove copyright protected materials from the internet. If a provider does not have a DMCA policy, then they may not have immunity from copyright infringement claims. This means you could send a copyright infringement threat letter directly to that third party provider unprotected by DMCA immunity provisions.

An experienced DMCA attorney can help you understand how to send a DMCA take-down notice, who to send it to and what to expect by way of response. Understanding how to send a DMCA notice correctly will save you a lot of time and money down the road.

VARIATIONS OF CYBERSQUATTING

While you may know what cybersquatting is generally and what potential legal action you can take for remedies under the Anticybersquatting Protection Act (“ACPA”), not knowing specific techniques used by cybersquatters may leave you unaware that you are currently being or have been a victim of cybersquatting. Cybersquatters use a variety of techniques to benefit from your trademark, so it is important for you to understand the variations of a cybersquatting in order to identify if your trademark has been illegally infringed upon by a cybersquatter.

One common form of cybersquatting is typosquatting. Typosquatting as a practice can be defined through a few different methods, which include misspelling or phrasing, as well as using a separate top-level domain (TLD). Misspelling or phrasing occurs when cybersquatters change the spelling of words or phrases slightly to benefit from internet users common typing mistakes to attract attention to a fake domain based on a misspelled legitimate domain, such as traverslegal.com instead of traverselegal.com. Notice the missing “e” in the first spelling? If not, you aren’t alone.

Another variation of typosquatting is top-level domain swapping by simply changing a .com domain to a separate TLD domain such as .org, or .net. A notable example was whitehouse.com, which adversely affected whitehouse.gov by displaying pornographic material. Mistakes in knowing which TLD is associated with a site like this are common, and cybersquatters take advantage of these mistakes by setting up a fake website cosmetically designed to imitate the original, and adversely affect your trademark by stealing your web traffic, compel you to buy the cybersquatted domain, or simply by spreading malware using your brand name.

Another form of Cybersquatting is a type of Identity theft associated with the registration of domain names. There are software products that a cybersquatter can use to monitor domain registration expiration, and if the domain is not renewed in time, they can purchase that domain, and either imitate your website to make your site’s visitors believe that the cybersquatter is you, or perhaps worse a website with your competitor’s products or services and redirect them to that site or advertisements that contain your competitor’s products or services.

A final type of cybersquatting is known as reverse cybersquatting or otherwise known as reverse domain hijacking. This is the practice of brand owners attempting to secure a domain name legally owned by another person and who is not otherwise a cybersquatter. A brand owner may claim that they own the rights to your domain, and threaten legal action unless you transfer that domain over to them. This practice by the brand owner is often perpetrated by large companies or famous individuals and is an abuse of their trademark rights making wrongful claims against your rightfully held domain name.

Free Consultation with a Utah Intellectual Property Lawyer

When you need help with a DMCA take down notice, cybersquatting or other IP related legal matters, call Ascent Law for your free consultation (801) 676-5506. We want to help you.

Ascent Law LLC8833 S. Redwood Road, Suite CWest Jordan, Utah 84088 United StatesTelephone: (801) 676-5506

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from Michael Anderson http://www.ascentlawfirm.com/how-do-i-send-a-dmca-take-down-notice/

from Top Rated Utah Lawyer https://topratedlawyer.wordpress.com/2018/03/15/how-do-i-send-a-dmca-take-down-notice/

[jeenycruz-blog]

What Are The Steps Involved In Cosmetic Registration In India?

The Indian cosmetic industry is growing at a very fast pace. Manufacturers from worldwide seek to enter this market and reach one of the largest consumer bases in the world. When it comes to launching your product in this market, you will have to register it. The process for Cosmetic Import India can be complicated due to a variety of requirements that need to be met. This guide explains the relevant laws, requirements, and about the importance of getting assistance from consultants.

Relevant Cosmetic Products Laws in India

The Drugs & Cosmetics Act 1940 and Rules 1945 regulate the import of cosmetics in India. If your product is already approved and present in other markets, it can make it easier to have it registered in India. The steps involved in registering your product are described as following:

1. Product Classification

The first step is to classify your cosmetic product to determine whether it needs to be registered in the country or not. You should check the relevant annexure under the applicable Act to determine this. As a general rule, any cosmetic product that is imported into the country for the purpose of sale should be registered.

2. Appointing an Agent

Once you have found that your cosmetic product requires Registration in India, you will have to appoint your authorized representative. All foreign manufacturers are required to appoint their authorized Indian agent. This agent would be responsible for registration of your product in India on your behalf. They will be your point of contact for the authorities, provide support with getting approval for your product, and handle the registration process.

3. Submitting Relevant Form & Documentation

You will have to prepare a list of supporting documents and submit it online along with the relevant form. Once the application is submitted with the required fees, the registration process will start. The required documents are as following:

·         Online Generated Form 42

·         Cover letter by the applicant

·         Treasury challan as evidence of submitted fees

·         Power attorney

·         Copy/original copy of the label

·         Schedule D (III)

·         Product specifications along with COA & testing protocol

·         Manufacturing license, marketing authorization letter or free sale certificate (if available)

·         Information about the countries with granted registration/import permission/market authorization

·         Information about manufacturer, brands and products

The requirements can vary from time to time. Your local consultant can make the process simpler and faster because they stay up-to-date with the latest changes.

Seek Professional Assistance

If you want to have a hassle-free registration procedure, it is important that you have thorough knowledge of the procedure and the requirements specific to your cosmetic product. The statutes of the relevant laws can change from time to time. Besides, the complexity of the procedure makes it important for you to seek professional assistance. An experienced consultant can help throughout the process. Whether it’s determining your product needs registration, or preparing all the documentation, they can help you with each and every step of the process.

So if you want to introduce your cosmetic product into the Indian market, make sure you have the knowledge of the relevant laws. Getting assistance from a licensed consultant can make the process much simpler and faster.

[shawnhannon7785-blog]

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How Regulatory Reporting Can Help in Medical Device Introduction in India

The Indian medical device market is growing at an unprecedented rate. Currently valued at approximately USD 12 billion, it is projected to reach USD 50 billion by 2030. This growth presents a lucrative opportunity for manufacturers and importers to introduce their medical devices in India.

However, entering this market requires careful navigation through stringent regulatory approval processes. To ensure a successful launch, having a robust plan for regulatory reporting is crucial.

In this blog, we will explain how regulatory reporting can assist in introducing a medical device in the Indian market.

Governing Body for Medical Device Registration in India

The Central Drugs Standard Control Organization (CDSCO) serves as the National Regulatory Authority of India, overseeing medical device registration and ensuring compliance with regulatory standards.

Who Can Apply for Medical Device Registration Under CDSCO?

The following parties are eligible to register medical devices with CDSCO:

Manufacturers with a registered office in India

Authorized representatives of the manufacturer

Subsidiaries of the manufacturer

Importers

Domestic manufacturers

For more information, refer to our blog, "7 Key Steps In CDSCO Medical Device Registration: Easy Guide."

What is Regulatory Reporting?

Regulatory reporting involves the systematic preparation and submission of documentation required for gaining approval to launch medical devices in the Indian market. This process is key to ensuring compliance with CDSCO regulations and other local standards.

Importance of Regulatory Reporting

Effective regulatory reporting facilitates:

Timely Market Access: Accelerating product approvals for quicker entry into the market.

Risk Minimization: Identifying and mitigating potential regulatory risks.

Regulatory Compliance: Ensuring adherence to evolving standards and regulations.

Resource Optimization: Enabling efficient allocation of resources during the approval process.

Key Components of Regulatory Reporting

A comprehensive regulatory reporting strategy consists of the following elements:

Product Type Identification Determine whether the product falls under medical devices, In Vitro Diagnostics (IVDs), cosmetics, or drugs, as each has distinct regulatory frameworks.

Risk Classification Establish the risk class of the device, as this impacts the regulatory requirements and approval pathway.

Existing Predicate or Similar Device Identify if a similar device exists in India. A predicate device demonstrates substantial equivalence and simplifies the approval process. If no predicate exists, additional steps are required. For more details, refer to our blog, "CDSCO Approval Process for Medical Devices Without Predicate in India."

Regulatory Status in Other Countries Leverage approvals from other countries to demonstrate safety, efficacy, and quality. This may also qualify the device for certain waivers, such as clinical trial exemptions.

Warehouse Availability & Registration Ensure that a warehouse is available and registered (Form MD-42). This is a mandatory prerequisite for introducing a medical device in India. Refer to our blog, "Registration Certificate for Sale," for further guidance.

Conclusion

The Indian medical device market presents tremendous opportunities but also demands adherence to stringent regulatory requirements. Comprehensive regulatory reporting ensures a clear pathway for product approval, minimizing delays and ensuring compliance.

Regulatory Solutions India (RSI) offers over 12 years of expertise in regulatory reporting, guiding companies through the complex process of medical device, IVD, cosmetics, and drug registration. Contact us today to streamline your product’s journey into India’s rapidly growing healthcare market. Partnering with RSI will help you bring your innovations to patients while ensuring compliance and commercial success.

[godollyfan]

[rajnidhiman]

What is cosmetic analysis testing and how to obtain a cosmetic license in India?

As per the present scenario in India, the cosmetic industry is not only blooming but it is also estimated that the growth of this industry will increase by three times in the next 5 years. 

At the same rate, the awareness of these cosmetic products is also increasing. Indeed, establishing a cosmetic business can prove to be highly profitable but there are certain regulations you have to abide by.

The cosmetics products are the kind of products that are rubbed, sprayed, poured and sprinkled to the human body to cleanse, beautify, and enhance the appearance and attractiveness. In India, cosmetic products are regulated by the Central Drugs Standard Control Organization.

To meet the vast requirement of the Indian population, various cosmetic products are imported as well as extensively manufactured. 

But to make sure they are safe for use, they must undergo strict quality assurance checks before reaching the customer. 

The Ministry of Health and Family Welfare in our country ensures the safety of these products by mandating cosmetic analysis tests to check whether the product abides by the set quality standards or not.

It is also mandatory to get the sample tested before the product registration and to present the results during cosmetic registration. Several cosmetic testing service providers are offering hassle-free testing starting from initial analysis to penning down the outcomes.

The cosmetic analysis test is done as per the rules set by the Bureau of Indian Standards. The cosmetic testing includes:

●       Physical and chemical analysis.

●       Tests to know about the presence of any heavy metals.

●       Microbial testing to make sure the absence of microbial counts as well as pathogens.

●       All kinds of physical testing such as viscosity, pH, specific gravity etc.

●       Analysis of fragrances, colorants, and the preservatives used.

Before there were no such rules for importing and manufacturing of cosmetic products, but with increasing awareness the government of India is compelled to frame various policies to make sure that the cosmetic products are accurately tested in various labs and are free from all potentially harmful ingredients.

One such requirement is the cosmetic registration license which the importer needs to obtain before the introduction of their products in the Indian market.

For the operation of cosmetic business the following licenses should be obtained

●       For selling or manufacturing, the cosmetic license is provided in form 32.

●       Form 32-A is a loan license is issued for manufacture/ sale or distribution of cosmetics. 

In short, every cosmetic product being imported and intended to be marketed and distributed in India should be registered with licensing authority under Drugs & Cosmetic Rules, 1945. The license is provided for three years after which it should be renewed.

For obtaining the license for cosmetics the documents that are needed are power of attorney, duly signed copy of Form 42, a certificate for free sale, certificate of marketing authorization and manufacturing, fees as required, product-related documents like product formula, certificate of analysis and artwork and some other documents.

For obtaining the license you have to undertake the following steps:

●       First, fill up the cosmetic license application form online and provide accurate details related to the manufacturer.

●       Then upload all required documents using the online portal in form 42

●       After proper verification of documents, your license for cosmetic business will be provided in Form 43

So, these are a few important things you should know if you are thinking of getting involved in cosmetic business in India.

[godollyfan]

Cosmetic Registration in India

The brand name proprietor, who has no manufacturing unit in India intends to sell his goods by the method of import through their appointed shippers/merchants/advertisers in India, is currently needed to obtain a registration authentication to continue with their marketing exercises in India. An application for registration on Form-42, alongside all essential documents is required to be submitted to Drugs Controller General (I), CDSCO, FDA office in New Delhi.

[godollyfan]

The Criteria Of Application Fee For Cosmetic Registration In India

In India, the cosmetic industry is gaining immense popularity at a rapid speed. With a rapidly growing industry it is important to make sure the product safety and this is the reason the Ministry of Health and Family Welfare in India has made it mandatory to obtain the registration certificate for cosmetic imports in India.

For importing cosmetics in India

 The manufacturer should have a registered office in India.

An authorized agent of the manufacturer or a subsidiary agent of the manufacturer.

The cosmetics should be registered with CDSCO under the Ministry of Health and Family Welfare.

Submit the filled application form to Central Drug Standards Controller of India in electronic form.

It is also required to submit the application form 42 along with the cover letter. It is a receipt in support of the original payment of the registration fees of amount USD 2000.

The office of the DCGI will then provide a copy of the cover letter that serves as an acknowledgement.

The whole process of issuance of registration certificate takes about 60-90 days and once obtained the certificate is valid for about 3 years. With the completion of the validity period, it is required to renew the registration certificate.

Some of the necessary documents required for obtaining a registration certificate are:

Complete detail of the manufacturer along with the manufacturing unit.

A valid import export code.

Proof of payment of the registration fees.

Details of the product that is to be registered that includes the name of the brand, date of manufacture, size of the pack, etc.

Details on the manufacturing license or the registration or the marketing authorization.

In the proposed guidelines for registration of imported cosmetics, all the cosmetic products have been put into a category.

This categorization of the cosmetic product is very important as it is required by the Government for charging the cosmetic registration application depending on every category as well as a variant. As per the new rules, the fees are 2000 USD per each category and 50 USD for every variant.

[godollyfan]

Some Insights On The Renewal Of Cosmetic Registration Certificate

For a better approach to lifestyle along with self-care and increasing capacity for purchasing, demand for all kinds of cosmetic products is increasing day by day in India.

To protect and uphold the real worth of cosmetics, all products are under the regulation of Drugs and Cosmetics Act 1940. All manufacturers, producers along with the distributors are required to obtain a registration certificate before introducing the cosmetic product in the market.

A registration certificate has a validity period of three years from the date when it is issued. Once the validity period is over, it should be renewed to continue selling the products.

The registration of cosmetic products along with its renewal is to make sure the product is effective, is of good quality and is safe for use. But the whole process needs some tedious paperwork that too within some stringent timelines.

On 15th October 2015, CDSCO issued some new clarifications along with existing guidelines with a focus on import and registration of cosmetics.

Here are the documents required for obtaining the renewed cosmetic registration certificate:

Power of attorney

Required fees

Form 42 filled and signed along with the product list that has to be renewed.

Certificate of free sale or the manufacturing license or marketing authorization.

Copies of the original registration certificate along with the endorsement certificates.

Undertaking or the self-declaration that states there is no change in the information provided earlier about the product details and the constitution of the form along with the source of location or the product site.

The registration certificate has to be renewed only after the validity has expired. However, to ensure proper compliance with legal regulations, a renewal application must be filed before the date of expiration of the certificate.

The whole process of obtaining cosmetic registration and re-registration might be tedious but with the help of an agent, the process becomes easy, quick and simple. They help the process by removing all unnecessary challenges.