Medical devices play a crucial role in maintaining the health and well-being of people. The number of medical devices on the market is increasing quickly due to the quick advancement of medical technology. The Central Government of India has amended the Medical Device Rules, 2017 to simplify and improve the regulation of medical devices in the country for Class A Non-Sterile and Non-Measuring Medical Devices.
What are Class A Non-Sterile and Non-Measuring Medical Devices?
The regulatory authorities have defined a number of medical device classes, including Class A non-sterile and non-measuring medical devices (NS/NM). As these are low-risk medical devices, they are generally exempt from the rigorous testing and certification required for higher-risk devices. Common non-measuring and non-sterile devices include items such as
- Scissors/knives
- Scalpels
- Examination gloves
- Ostomy bags
- Ophthalmic lenses
- Hospital Beds, etc,
Registration Procedure for Class A NS/NM Devices
The Class A Non-Sterile and Non-Measuring Medical Devices Rules, 2022 aims to simplify registration. The rules propose to alleviate the regulatory burden on the industry by allowing manufacturers and importers of these devices to perform self-certification and self-attestation. The goal is to make bringing these medical devices to market easier.
1. The manufacturers and importers must register their medical devices through an online portal established for the purpose of registering Class A NS/NM devices.
2. The manufacturer/importer must upload the following information for registration: name and address of the manufacturing site, details of medical device and other required information.
3. After the information is uploaded, a registration number will be generated.
4. The manufacturer/importer must maintain records of manufacturing/import and sales/distribution and produce them upon request from Licensing Authorities.
5. The State/Central Licensing Authority may cancel or suspend the registration number if the registrant fails to comply with any of the above compliances.
Documentation/Compliance required for class A non-measuring non-sterile medical devices registration in India
1. Confirmation of Class A Medical Device Status: The proposed devices are categorized as Class A Medical Devices and are non-sterile and non-measuring.
2. Essential Principles Compliance: The Importer/Manufacturer must certify that the product conforms to the essential principles checklist for safety and performance.
3. MDR 2017 Compliance: The Importer/Manufacturer must also self-certify that the product conforms to MDR 2017.
4. Authenticity Guarantee: The Importer/Manufacturer must sign an undertaking to affirm that the information provided is accurate and authentic.
5. Registration Number: Upon submitting the required information online, a registration number will be provided to the Importer/manufacturer.
6. Manufacturing Site Documentation: The importer must additionally present a self-attested copy of the registration of the manufacturing site, establishment, or plant abroad, or a Free Sale Certificate issued by the National Regulatory Authority in the country of origin.
7. Responsibility: The Importer/Manufacturer must take full responsibility for the authenticity of the information provided and for ensuring compliance with all regulations and requirements.
Conclusion
Class A Non-Sterile and Non-Measuring Medical Devices (NS/NM), though having a low-risk class, these devices play an important role in a variety of medical procedures. It is important that importers/manufacturers follow the proper registration process ensuring that their devices are properly registered and compliant with the regulations. The simplified registration process for Class A Non-Sterile /Non-Measuring Devices is indeed a welcome move by the regulatory authorities for the medical devices industry.
About Regulatory Solutions India
Regulatory Solutions India (RSI) has provided registration services for over 400 medical products in India since its establishment in 2011. Our expertise covers a wide range of products including medical devices, IVD, and cosmetics across more than 25 categories such as stents, catheters, intraocular lenses, orthopedic implants, ablation devices, surgical dressings, hypodermic syringes, needles, and more. We have served clients from 15+ countries and offer technical, strategic, and project management support to our clients.
RSI specializes in providing registration services for Class A non-sterile and non-measuring medical devices in India, and we take pride in our high-quality work and excellent customer service. Choose RSI for all your regulatory compliance needs, and we guarantee that you will not be disappointed.
