Class A Non-Sterile and Non-Measuring Medical Device Registration & Import Process (G.S.R. 777(E)) - No License Required
Manufacture of Class A Non-Sterile and Non-Measuring Medical Devices (As per G.S.R. 777(E))
In accordance with G.S.R. 777(E), the Medical Devices (Sixth Amendment) Rules, 2022 introduce a simplified regulatory process for the manufacture of Class A non-sterile, non-measuring medical devices. These devices are now exempt from the licensing regime, meaning manufacturers are no longer required to obtain an MD-5 License. Instead, they must complete a straightforward registration process using the Online System for Medical Devices.
Streamlined Registration Process for Manufacturers class A Non Sterile and Non Measuring device
To register a Class A non-sterile, non-measuring medical device, manufacturers need to provide the following details:
- Manufacturing Site Information: Name and address of the manufacturing facility.
- Product Information:
- Generic name of the device.
- Brand name (if registered under the Trade Marks Act, 1999).
- Model number (if applicable).
- Intended use.
- Material of construction.
- Device dimensions (if applicable).
- Shelf life (if applicable).
- Self-Certification:
- Confirmation that the device is classified as Class A Non-Sterile and Non-Measuring Medical Devices under the Medical Devices Rules.
- Certification that the device complies with the essential principles of safety and performance.
- Certification that the device meets applicable standards under the Medical Devices Rules.
- Manufacturer’s Undertaking: A declaration affirming the accuracy of the information provided.
Once this information is uploaded to the Online System for Medical Devices, a registration number will be generated. This registration number authorizes manufacturers to produce and market the device without the need for an MD-5 License.
Record-Keeping and Compliance:
Manufacturers must maintain detailed records of production, distribution, and sales. These records may be reviewed by licensing authorities at any time, particularly in the event of safety or quality concerns. Non-compliance could result in the suspension or cancellation of the registration.
Import of Class A Non-Sterile and Non-Measuring Medical Devices (As per G.S.R. 777(E))
The Medical Devices (Sixth Amendment) Rules, 2022, introduced via G.S.R. 777(E), have significantly simplified the process of importing Class A non-sterile, non-measuring medical devices into India. These devices are now exempt from the MD-15 import license requirement. Importers must only complete a registration process on the Online System for Medical Devices, making the regulatory process faster and more efficient
Registration Process for Importers for class A Non Sterile and Non Measuring device:
To import Class A non-sterile, non-measuring devices, importers need to submit the following information:
- Importer and Manufacturer Information:
- Name and address of the importer.
- Name and address of the overseas manufacturer.
- Product Information:
- Generic name of the device.
- Brand name (if registered under the Trade Marks Act, 1999).
- Model number (if applicable).
- Intended use.
- Material of construction.
- Device dimensions (if applicable).
- Shelf life (if applicable).
- Self-Certification:
- Confirmation that the device is classified as Class A Non-Sterile and Non-Measuring Medical Devices.
- Certification of conformity with the essential principles of safety and performance.
- Certification of compliance with relevant standards.
- Supporting Documentation:
- Free Sale Certificate or proof of registration in the country of origin issued by the national regulatory authority.
- Importer’s Undertaking: A signed declaration affirming the truth and accuracy of the submitted information.
After the successful upload of the required information, a registration number will be generated, authorizing the import of the medical device without the need for an MD-15 import license.
Record-Keeping and Compliance:
Importers must keep records of imported devices, sales, and distribution, and these records must be available for inspection by licensing authorities. In case of any product-related issues or quality concerns, authorities may conduct investigations, which could lead to suspension or cancellation of the registration.
How Accordmed Can Help
At Accordmed, we simplify the import process for Class A non-sterile, non-measuring medical devices. Our expert team handles:
- The preparation and submission of all required registration documents.
- Self-certification and Free Sale Certificate validation.
- Compliance with safety, performance, and regulatory standards.
We ensure that your products are registered seamlessly, enabling you to bring them into the Indian market without delays. With our deep knowledge of Indian medical device regulations, we help you navigate every step of the process, ensuring full compliance and smooth market entry.
By partnering with Accordmed, you can trust that all regulatory requirements will be met, allowing you to focus on expanding your product reach without the administrative hassle.
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