Class A non-sterile non-measuring medical devices –
Final notification GSR 777(E) was released by the Indian Ministry of Health and Family Welfare on October 14, 2022, formally exempting Class A non-measuring and non-sterile medical devices from the Import License (MD-15) procedure.
Following this most recent final notification from the MoHFW, Class A medical devices that are non-measuring and non-sterile must register immediately through a quick online registration process like the voluntary registration process. This requirement was first proposed in the draft notification GSR 710(E) on September 20, 2022. This opens a quicker route to market entry for manufacturers of Class A devices by significantly streamlining the Indian market for low-risk medical devices.
New India regulations for medical devices – Adding a new Chapter IIIB to the MDR 2017, this update to the Medical Device (Sixth Amendment) Rules, 2022 exempts Class A non-sterile and non-measuring medical devices from the licensing regime. As part of this, Class A (non-sterile, non-measuring) medical devices must be registered via a link on the online portal. Therefore, importing these devices does not require an import license (MD-14/MD-15). Class A sterile devices and Class A measuring devices, on the other hand, will need an import license; the application process for acquiring one for these medical devices is still the same.
Examples of Class A non-sterile non-measuring medical devices are walking sticks, Crutch, Scalpel, etc.
The registration process in India: The procedure for registering in India to produce or import Class A non-sterile, non-measuring medical devices is given below:
Step 1: Determine whether the device is a Class A nonsterile, non-measuring medical device.
Step 2: If so, the candidate must register the device through the Online system for medical device” add non-regulatory device” section.
Step 3: The applicant must decide whether they are an importer, a manufacturer, or both.
Step 4: The applicant must then upload the files by their category.
For manufacturer | For Importer |
Name and address of the manufacturer | Name and address of the importer and manufacturing site. |
Details of Class A medical device that comes under the non-sterile and non-measuring class | Details of Class A medical device that comes under the non-sterile and non-measuring class |
An agreement from the manufacturer attesting to the item’s classification as a Class A non-sterile, non-measuring medical device. | A declaration from the importer attesting to the item’s classification as a Class A non-sterile, non-measuring medical device. |
The manufacturer’s self-certificate attests to the product’s compliance with the fundamental guidelines and requirements outlined in GSR 777. | The importer’s self-certificate attests to the product’s compliance with the fundamental guidelines and requirements outlined in GSR 777. |
An undertaking from manufacturing stating that the details mentioned by the manufacturer are authentic | A free sale certificate from the National Regulatory Authority or a self-attested copy from the responsible authority of the manufacturing site located abroad in the country of origin. |
| An assurance from the importer that the information the manufacturer provides is accurate. |
Step 5: A “Registration number” will be generated once the documents have been uploaded. This number must be added to the label to sell it in the Indian market.
With its sale and distribution, the applicant must keep track of any manufacturing or import documentation. The license to sell Class A non-sterile, non-measuring medical devices may be revoked if the applicant fails to produce the records for verification when requested by the licensing authority.
Simple registration procedure for non-sterile and non-measuring devices – Device Master File (DMF) and Plant Master File (PMF) submission is not required for Class A non-measuring and non-sterile devices. This is significant because many manufacturers will now be exempt from registering the product’s DMF and the manufacturing site when they outsource their Class A Non-M/S instruments. This can save hundreds or thousands of dollars in CDSCO fees, up to nine months of review time, and more thorough document preparation.
The following chapters of the Medical Devices Rules, 2017 exempt importers of Class A non-sterile, non-measuring medical devices from all their provisions:
- Chapter V – Import of medical devices,
- Chapter VII – Clinical investigation of medical device and clinical performance evaluation of new Invitro diagnostic medical device,
- Chapter VIII – Import or manufacture a medical device which does not have a predicate device,
- Chapter XI – Sale of medical devices
Validity – The State Licensing Authority or the Central Licensing Authority has yet to specify the license’s validity period. Until the regulation has strict guidelines, importers and manufacturers can still use the registration number.
Timeline – For medical devices explicitly made for this purpose, the Manufacturer or Importer can immediately obtain the Registration number on the Online System by supplying the required information.
Essential Tips – When completing the registration process, keep the following important points in mind:
- The applicant must meet the medical device essential principle (EP) checklist.
- The applicant has to take great care in preparing all the necessary paperwork for registration, such as the medical device undertaking, the self-certification, and information about the overseas manufacturing site, establishment, or plant registration.
- When registering a medical device, importers are required to possess a Free Sale Certificate (FSC).
- If the applicant fails to submit the following paperwork, there may be issues during the registration process:
- An agreement certifies that the suggested medical device is a non-sterile, non-measuring Class A device. The applicant’s information must be accurate and genuine.
- The application confirms that the product satisfies the requirements outlined in these rules and self-certify that it follows the essential principle’s checklist for the safety and performance of such devices.
- A copy of the overseas manufacturing site, establishment, or plant registration that has been self-attested must be provided by importers.
Additional comments – Applicants must manually upload every model number and detail once more in the new portal if they have previously applied for Class A non-sterile, non-measuring devices on the portal. There is no way to export data submitted using the previous online system to the new one.
This Rule does not specify the need to submit information about the accessories and parts of Class A non-sterile and non-measuring, in contrast to the Voluntary Registration. This is due to the requirement placed on the manufacturer to prove that the suggested devices are Class A Medical Devices, meaning they are not sterile and are not measuring devices.
Furthermore, these products are exempt from restrictions regarding their country of origin or ability to obtain the Free Sales Certification (FSC) from the GHTF nations of the USA, UK, Japan, Canada, Australia, or the EU. In contrast to the existing requirement, it can come from any country.
Conclusion – The recent regulatory updates introduced by the Indian Ministry of Health and Family Welfare present a significant and positive shift for manufacturers and importers of Class A non-sterile, non-measuring medical devices. The exemption from various chapters of the Medical Devices Rules, 2017, further facilitates the importers of these devices. These regulatory changes create a more efficient and accessible pathway for Class A non-sterile, non-measuring medical devices in the Indian market, promoting innovation and facilitating industry growth while maintaining a commitment to safety and compliance.