The registration was supposed to be completed by September 30, 2021 on the timeline which was earlier awarded by the Controller General of Drugs of India (DCGI) to medical device manufacturers for voluntary registration.

Ministry of Union Health, MD Amendment Draft Rules, 2021, ISO 13485, DCGIThe voluntary registration was supposed to be completed by September 30, 2021 on the schedule earlier awarded by the Controller General of Drugs of India (DCGI) to medical device manufacturers.

The Ministry of Health notified the union of Medical Device Amendment (MD) Draft Rules, 2021 to allow more time for medical device manufacturers to comply with ISO 13485 certification by November 30, 2021 than the previous schedule on September 30, 2021. A prerequisite for securing registration for medical devices as part of the licensing process.

The voluntary registration was supposed to be completed by September 30, 2021 on the schedule earlier awarded by the Controller General of Drugs of India (DCGI) to medical device manufacturers.

As per the union health ministry’s earlier notification on February 11, 2020, medical devices were subject to the voluntary registration system from April 1, 2020 until the end of September 2021.

The Medical Device Amendment Draft Rules, 2021 notified by the Ministry proposed the inclusion of a requirement and explanation, under Rule 19b, in sub-rule (2), in Clause (3), where the rules state that certification of compliance with respect to the ISO 13485 standard approved by The National Accreditation Council of Certifying Bodies or the International Accreditation Forum in relation to medical devices must be uploaded for registration on the online system for medical devices, established by the Central Drug Standards Monitoring Organization (SEDCO).

The notification further states that “provided that in the event that the applicant submits, on or before 30 November 2021, an undertaking that the applicant will obtain an ISO 13485 Certificate on or before 31 May 2022 in lieu of a Certificate of Compliance as referred to in Clause (3) of Sub-rule (2) of Rule 19b, a provisional registration number which shall remain valid until May 31, 2022 or the date on which the applicant obtained such ISO certification, whichever is earlier, shall be established.The said provisional registration number shall be valid for all purposes.

For the removal of doubt, it is hereby declared that in the event that the ISO 13485 certificate has not been obtained before May 31, 2022 in accordance with the undertaking referred to in the clause by the applicant, the provisional registration shall be deemed to have been revoked for all purposes without any notice.”

In the said rules, in Rule 19c, for the phrase “registration number shall be cited”, the following words, letters and numbers shall be substituted, namely: – “The registration number or provisional registration number may, if desired, be mentioned, as the following may be the case , for a period of up to May 31, 2022, after which it becomes mandatory for all registrants.

In the said Rules, in Rule 19D, in sub-rule (2), in clause (3), at the end, insert and explain the following clause, i.e.: or before November 30, 2021, undertake that the applicant will obtain ISO 13485 certification on or Prior to May 31, 2022 in place of a Certificate of Compliance as referred to in Clause (3) of Sub-Rule (2) of Rule 19d, a provisional registration number must be generated that will remain valid until May 31, 2022 or the date on which the Applicant obtained this ISO Certificate , which is closer. The said temporary registration number must be valid for all purposes.

For the removal of doubt, it is hereby declared that in the event that the ISO 13485 certificate has not been obtained before May 31, 2022 in accordance with the undertaking referred to in the clause by the applicant, the provisional registration shall be deemed to have been revoked for all purposes without any notice.”

In the said rules, in Rule 19E, the phrase “the registration number shall be stated” shall be replaced by the following words, letters and numbers, namely: – “The registration number or provisional registration number may, if desired, be mentioned, as the following may be the case, for a period up to May 31, 2022, after which it becomes mandatory for all registrants.”

According to the notification of the union health ministry, the following draft specific rules for the amendment of the Medical Devices Rules, 2017, which are proposed by the central government, in the exercise of the powers granted under subsection (1) of subsection 12 and subsection. Section 1 of Section 33 of the Medicines and Cosmetics Act 1940 (23 of 1940) and in consultation with the Pharmaceutical Technical Advisory Board (DTAB) is hereby published for information to all potentially affected persons.

Notice is hereby given that said Draft Rules shall be taken into consideration upon or after the expiry of a period of seven days from the date on which copies of the Official Gazette of India containing these Draft Rules are made available to the public. The Central Government will consider the objections and suggestions that may be received from any person within the specified period.

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