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All Class A and B Devices Require Import Licenses beginning October 1, 2022
All Class C and D require an Import License by October 1, 2023 and Registration beforehand.
For the latest information on the regulatory process in India, please see our page on the topic here.
India Issues Draft Notification for Exempting Certain Class A Medical Devices
Published on: September 28th, 2022
Note: The CDSCO has finalized this Notification here.
Our blog on the final Notification can be read here.
The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile. In an endeavour to simplify market access for low-risk medical devices, the Ministry of Health and Family Welfare (MOHFW) through this draft notification has inserted Chapter IIIB in the MDR 2017 to exempt Manufacture/ Import Licensing of Class A medical devices that are non-sterile and non-measuring.
While Class A non-measuring and non-sterile devices won’t require an Import License, they will still require registration and self-certification to certain standards.
G.S.R. 710(E) —The draft of certain rules to amend the Medical Device Rules, 2017, is published and notice has been given that the draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date of publication, i.e. 27 September 2022 (Tuesday). Objections and suggestions may be sent to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at firstname.lastname@example.org.
Link to access draft notification:
Potential Requirements for Some Exempt Class A Devices
Main highlights from draft G.S.R. 710(E) include:
- In summary, complete exemption is being provided to Class A non-sterile and non-measuring medical devices from the requirements of Manufacturing and / or Import License (MD-15).
- However, the requirements for Quality Management System, Distribution License, Labelling and Post Market Surveillance are not exempted and are likely to remain as per the current Rules of the Medical Device Rules, 2017.
- The MOHFW / CDSCO will soon have a new online portal that will be designed to upload the information of the Class A non-sterile and non-measuring medical devices.
- While the information upload requirements appear to be largely similar to the Voluntary (and now Mandatory) Registration, there are some differences in the document requirements.
- Once the information has been submitted, a registration number will be immediately generated.
- The timelines for implementation including when the portal will be ready and the registration can begin has not been specified.
- At this time, there is no mention of next steps for the companies who have already applied for a Manufacturing License / Import License for their Class A non-measuring or non-sterile device.
- It appears that the Form MD-14 application uploads previously done by applicants may need to be repeated on the new portal unless the CDSCO provides a bridging mechanism to use the data from submitted applications and grant registration numbers.
Draft Registration Process for Class A Exempt Devices
The Draft Notification G.S.R. 710(E) would require manufacturers to still register Class A exempt devices on a new online portal similar to the current Registration process. As of October 1, 2022, only non-Notified Class C and D medical devices can be Registered while all Class A and B and Notified Class C and D require Import Licenses.
- Local manufacturers or Registrants will need to upload product information similar to the current Registration requirements. Required informaiton includes:
- The name and address of importer and the name and address of the manufacturing site
- Generic Name
- Brand Name (if registered under the Trade Marks Act,1999)
- Model No (if any)
- Intended use
- Material of construction
- Dimension (if applicable)
- Shelf life (if applicable)
- Self-certification from the Importer that the product conforms to the essential principles checklist of safety and performance of such devices
- Self-certification from the Importer that the product conforms to MDR 2017, Rule 7 Product standards for medical device
- Self-attested copy of the overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority or Free Sale Certificate issued by the National Regulatory Authority.
- If the registrant fails to comply with the conditions of the manufacturing license or any provisions of the Act and the MDR 2017, the Central Licensing Authority (CLA) may cancel or suspend the registration number of such medical devices. Adequate opportunities for grievance redressal have been provided to registrants.
Come Grow With Us
Please contact us if you’d like support from our experienced staff registering your device in India. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.