In Feb 2020, Ministry of Health and Family Welfare (MoHFW) issued Gazette Notification G.S.R 102E defining the rules for registration requirements of non-notified medical devices under India Medical Devices Rules 2017. These rules are effective from 01 April 2021 along with transition timelines of 18 months for the purpose of voluntary registration. Based on various representations received from stakeholders, Ministry has amended Rules 19B, 19C, 19D and 19E to introduce new provisions for registration of non-notified medical devices through Gazette Notification G.S.R 19E on 18 Jan 2022. Following are the key features of this update:
1. Relaxation in ISO 13485 certificate timelines (amendment in Rule 19B and 19D):
Applicants are allowed to submit undertaking on or before 28 Feb 2022 that they shall obtain ISO 13485 certificate on or before 31 May 2021. A provisional registration number will be issued to applicants submitting undertaking which will remain valid up to 31 May 2022 or the date on which applicant obtained such ISO certificate whichever is earlier. Provisional Registration will stand cancelled if ISO 13485 certificate is not obtained before 31 May 2022.
2. Relaxation in labelling timelines (amendment in Rule 19C and 19E):
Manufacturer/ Importer may voluntarily provide registration or provision registration number on the label of product up to 31 May 2022. However, the labelling requirements will become mandatory for all registration holders from 01 June 2022.
It should be noted that Rule 19A subrule 2 is not amended to extend voluntary registration period of 18 months from the date of commencement of G.S.R 102(E). Hence, we are already into the period of mandatory registration from 01 Oct 2021 along with additional relaxation given to applicants not having ISO 13485 certificate, as mentioned above. All importers and manufacturers must make all efforts to complete registration of non-notified devices as soon as possible. Reach out to us at info@innoreg.in in case you need regulatory assistance with the registration process.
Reference: https://egazette.nic.in/WriteReadData/2022/232729.pdf, seen on 23 Jan 2022
Disclaimers: The information contained in this blog is intended for general information purpose only and does not consider the particular circumstances of your business. InnoReg Solutions or the author is not liable for any consequences of any action taken by the user relying on material / information provided in this blog. You should separately seek regulatory advice or consultation for your particular business needs.
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