Registration Process for Class A Non-Sterile and Non-Measuring Medical Devices in India

Medical devices are a vital part of the healthcare industry, playing a significant role in the prevention, diagnosis, treatment, and rehabilitation of medical conditions. India has been making rapid progress in the medical device industry, and the Central Government of India has taken several steps to simplify and improve the regulation of medical devices in the country.

One of the recent developments in this area is the amendment of the Medical Device Rules, 2017, which aims to simplify and improve the registration process for Class A NS/NM medical devices in India.

What are Class A Non-Sterile and Non-Measuring Medical Devices?

Medical devices are classified based on their risk profile, and the regulatory authorities have defined several medical device classes, including Class A non-sterile and non-measuring medical devices (NS/NM). These devices are considered low-risk medical devices and are generally exempt from the rigorous testing and certification requirements required for higher-risk devices.

Examples of Class A NS/NM devices include scissors, scalpels, examination gloves, ostomy bags, ophthalmic lenses, hospital beds, and other similar items.

Registration Procedure for Class A NS/NM Devices

The new registration process for Class A NS/NM devices allows manufacturers and importers to self-certify and self-attest, alleviating the regulatory burden on the industry and making it easier to bring these devices to market. The registration process involves uploading information such as the name and address of the manufacturing site and details of the medical device onto an online portal established for this purpose. Once the information is uploaded, a registration number is generated, and the manufacturer/importer must maintain records of manufacturing/import and sales/distribution.

Documentation and compliance required for Class A NS/NM devices registration:

Documentation and compliance required for Class A NS/NM devices registration in India includes confirming the Class A Medical Device status, certifying that the product conforms to essential principles checklist for safety and performance, self-certifying that the product conforms to MDR 2017, signing an undertaking to affirm that the information provided is accurate and authentic, presenting a self-attested copy of the registration of the manufacturing site or a Free Sale Certificate issued by the National Regulatory Authority in the country of origin, and taking full responsibility for the authenticity of the information provided and ensuring compliance with all regulations and requirements.

Conclusion:

In conclusion, Class A Non-Sterile and Non-Measuring Medical Devices (NS/NM) are important in various medical procedures. Importers/manufacturers must follow the proper registration process to ensure that their devices are properly registered and compliant with regulations. The simplified registration process for Class A Non-Sterile/Non-Measuring Devices is a welcome move by the regulatory authorities for the medical devices industry.

Regulatory Solutions India (RSI) offers high-quality registration services for Class A non-sterile and non-measuring medical devices in India, as well as technical, strategic, and project management support to clients. Choose RSI for all your regulatory compliance needs, and we guarantee excellent customer service.