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Updates on Compulsory Registration for Class C and D Medical Devices

Introduction:

In a significant regulatory shift, the Central Drugs Standard Control Organization (CDSCO) is set to revamp the compliance landscape for Class C and Class D (non-notified) medical devices, effective from October 1, 2023. The traditional mandatory registration process is making way for a more streamlined licensing system, in accordance with GSR 102(E) dated 11.02.2020. This article provides a comprehensive overview of these updates and what they mean for manufacturers and importers in the medical device industry.

Understanding the Regulatory Evolution:

Under the new licensing paradigm, manufacturers and importers must align with the Medical Devices Rules (MDR) 2017 while utilizing CDSCO's online portal for application submissions. This transition not only promises greater efficiency but also a significant reduction in paperwork. However, it is imperative that stakeholders remain diligent in preparing comprehensive documentation and complying with prescribed fees to expedite the licensing process.

Embracing Collaborative Progress:

As these changes take root, it's essential for industry stakeholders, including associations and regulatory bodies, to collaborate effectively. By working together, they can ensure a seamless transition and support the development of a more streamlined and resilient regulatory framework for the future.

Conclusion:

The shift from compulsory registration to a licensing system for Class C and Class D medical devices marks a pivotal moment in the industry's evolution. Manufacturers and importers must prepare for this regulatory transformation by understanding the new requirements and compliance procedures. As the industry adapts, a cooperative approach among all stakeholders will be vital in paving the way for a more efficient and responsive regulatory environment.

For expert guidance on navigating the changing regulatory landscape for Class C and Class D medical devices, reach out to Operon Strategist today.

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CDSCO Import License for Medical Devices

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India. The CDSCO is responsible for the registration, licensing, and regulation of medical devices in India.

To import medical devices into India, a valid CDSCO import license is required. The import license is issued by the CDSCO after the device has been registered with the organization. The registration process involves submitting an application along with relevant documents, such as product information, manufacturing details, and clinical trial data, to the CDSCO.

Once the registration process is complete, the CDSCO will review the application and issue an import license if the device meets the required standards and regulations. The import license will include details such as the name and address of the importer, the name and model of the device, and the quantity and value of the device.

It is important to note that certain medical devices may require additional approvals or certifications from other regulatory bodies in India, such as the Bureau of Indian Standards (BIS) or the Indian Council of Medical Research (ICMR) before they can be imported and sold in the country.

In summary, obtaining a CDSCO import license for medical devices in India involves registering the device with the CDSCO and ensuring that it meets the required standards and regulations. The CDSCO import license is a crucial requirement for importing medical devices into India, and importers must comply with all relevant regulations and requirements to ensure the safety and effectiveness of the device.

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CDSCO Classifications of medical devices.

CDCSO manages the affairs relating to the classification of medical devices. CDSCO classifies medical devices into four classes based on risk (A, B, C, and D) as per the regulation, which are as follows

Class A (Low Risk)

Class B (Low-Moderate Risk)

Class C (Moderate High Risk)

Class D (high Risk)

Class A (Low Risk) covers Absorbent cotton wools, surgical dressing, alcohol swabs etc.

Class B (Low-Moderate Risk) covers Thermometer, BP monitoring device, disinfectants etc.

Class C (Moderate High Risk) covers Implants, hemodialysis catheter etc.

Class D (high Risk) covers Angiographic guide wire, heart valve.

For more information Click here

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CDSCO Manufacturing License for Medical Device

CDSCO manufacturing license is mandatory for a company who want to manufacture any medical device in India. License is issues by The central Drugs Standard Control Organisation (CDSCO).

If you are looking for manufacturing License for medical device, We are here to help you. Following are the steps of CDSCO Manufacturing License:

Applicant Registration

Test License application

Manufacturing license application

Documents Requirements:

Documents required for this phase are address proof like certificate of registration or certificate of incorporation or Import-export certificate or MTNL/BSNL bill of corporate site, ID proof of authorized person, this person can be any person apart from management team who will be authorized to all types of registration.

For more information

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Cdsco medical device classification, Classification of medical devices in india,

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ISO 13485 Certification - ISO 13485 Medical Device Consultant

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Know more About Medical Device Regulatory Consultants

Medical device consultancies or the regulatory consultants are highly experienced professionals from healthcare industries. With rapid positive growth  in medical science, the medical device industry is coming up with more and more advanced devices. But launching a new product on the market is not easy. The devices should comply with all the regulatory bodies. For this reason, many companies hire a medical device regulatory  consultant, who helps them through the complex process of bringing their medical device into the market. These professional guide through many issues like regulatory compliance, clinical evaluation, and literature searches.  

Why do we need a medical device regulatory consultants ? 

The first and best answer for this is to avoid rejections.  In short, we need a consultant for easy and hazel free process. When we follow certain regulatory pathways we may face a few obstacles like rejection of application, queries raised by FDA or regulatory bodies can be resolved by consultant. Also, the medical device consultant always has an eye on changing regulations which we aren’t aware of. These professionals prepare technical files of documents like in FDA 510(k) case medical device consultant prepare FDA510(k) dossier or CE mark technical file which helps in the clearance process.  These people also analyze clinical trial data and optimize medical device design & development. 

Read More  - medical device regulatory consultants

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How to Choose a Medical Device Regulatory Consultants

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Clean Room Consultant for Medical Devices

Medical device manufacturing and packaging regulations and requirements are complex and compliance is critical. Our team of medical device cleanroom engineers take the time to understand your business, your products and your medical manufacturing processes to propose the perfect medical device cleanroom environment to comply with all requirements and ensure successful business operations. Our medical device clean rooms are certified to meet or exceed the required classification conditions in accordance with Federal Standard 209E and ISO 14644. The temperature, pressure and humidity are highly regulated and the air is repeatedly filtered to protect your medical device products and packaging from contamination. 

To ensure that your products remain under controlled contamination levels during your production process and packaging process, our medical device clean rooms guarantee to control and maintain temperature, humidity, pressure and contaminant levels. Our ISO 14644 calibrated medical device clean rooms control the introduction, generation, and retention of particulate, protecting your products and process from airborne contaminants or human-borne contaminants. 

Contact us to take advantage of our offer of expedited services with Operon Strategist as part of our clean room for medical device . 

Clean room consulting for compliance with USP 800 and 797, cGMP, as well as other regulatory requirements are often the most stressful aspect of starting your new healthcare or pharmacy cleanroom. Cleanroom Connection works with Operon, one of the nation’s leading pharmacy and healthcare consultants. Operon Strategist Associates is a pharmaceutical and healthcare consulting firm that provides comprehensive guidance globally to pharma and healthcare related organizations. Their experienced team helps organization overcome or confront challenges, reduce risks, and identify opportunities to outperform competition, setting them to achieve higher and more rapid success and to comply with applicable regulatory protocols. 

Operon has a track record of excellent service to public sector agencies. They are committed to providing a quality consultation and the valued services and expertise of a larger firm, while maintaining a personal touch and modest fees. 

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Medical Device Process Validation Guidance for Manufacturers

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Medical device validation Process consultant 

Medical Device Process Validation is a system of organising documentary proof demonstrating that a procedure, system or hobby completed in manufacturing continues the preferred degree of compliance in any respect stages.

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ISO 15378 certification