New Delhi : The ministry of health and family welfare (MoHFW) has issued final notification allowing time till May 31, 2022 for the medical devices industry to comply with the ISO 13485 certification, which is a prerequisite to get the devices registered with the drug regulator.
The amendment will allow issuance of provisional registration number for those applicant medical devices companies that submit an undertaking on or before February 28, 2022, that it shall obtain the ISO 13485 certification on or before May 31, 2022 in accordance with the stipulated Rules. A draft notification issued on October 12, 2021 extended the relaxation to those who submit the undertaking before November 30, 2021.
This comes as a relief to the industry at a time when the majority of the medical devices manufacturers complained difficulty in following the earlier fixed timelines for voluntary registration, due to difficulties in getting the ISO certification amidst Covid-19 pandemic and related disruption.
The Medical Devices (…Amendment) Rules, 2022, notified by the Ministry on January 18, inserts a proviso and explanation, under the Rule 19 B, in Sub Rule (2), in item (iii), to implement the required change.
In the said sub rule and item, states that the certificate of compliance in respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of the medical devices, has to be uploaded for registration on the online system for medical devices, established by the Central Drugs Standard Control Organisation (CDSCO).
The amendment in the rule adds a provision that in case the applicant submits, on or before February 28, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before May 31, 2022, in lieu of certificate of compliance, a provisional registration number shall be generated. This will remain valid up to May 31, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The generated provisional registration number shall be valid for all purposes.
The notification explains, “For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before May 31, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes without any notice”.
Further, under the Rule 19 C, the condition that the company “shall mention the registration number” on the label of the medical device shall be substituted with the condition that the manufacturer “may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period of up to May 31, 2022, thereafter it shall be mandatory for all registration holders” to mention the registration number on the label.
The notification also amends the Rule 19D sub rule (2) item (iii), related to the registration of medical devices by importers, adding a proviso and explanation to the effect that the importer can also submit an undertaking on or before February 28, 2022, that the company shall obtain the ISO 13485 certificate on or before May 31, 2022, in lieu of certificate of compliance. A provisional registration number shall be generated which will remain valid up to May 31, 2022, or the date on which the applicant obtained such ISO certificate, whichever is earlier. The provisional registration number shall be valid for all purposes.
It has also declared that in case the ISO certificate is not obtained before May 31, 2022, as per undertaking, the provisional registration shall be deemed to be cancelled for all purposes without any notice. Here also, the relaxation has been extended to the mentioning of registration numbers on the label.
According to the ministry of health and family welfare’s notification on February 11, 2020, the medical devices were under voluntary registration scheme from April 1, 2020 till end of September, 2021. From October 1, 2021, Class A & B medical devices will be under compulsory registration scheme up to September, 2022 and Class C&D medical devices will be under compulsory registration scheme up to September 2023. After the compulsory registration period, these classes will respectively move to the licensing regime.