CDSCO Announcement ISO 13485

CDSCO – Medical Device Industry – Announcement on ISO 13485 Certification

Announcement from MoHFW

NOTIFICATION Dt 18th January, 2022

Notification Content :

G.S.R. 19(E).—Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017, was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 729(E), dated the 12^th October, 2021, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of seven days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas, copies of the said Official Gazette were made available to the public on 12^th October, 2021;

And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), with consideration that consultation with Drugs Technical Advisory Board shall be held as per the provisions, the Central Government hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:― 

1. (1) These rules may be called the Medical Devices (….. Amendment) Rules, 2022.

                (2) These rules shall come into force on the date of their publication in the Official Gazette.           

• In the Medical Devices Rules, 2017 (hereinafter to be referred as said rules), in rule 19B,  in  sub-rule (2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

 “Provided that in case the applicant submits, on or before the 28^th February, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31^st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the 31^st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31^st May, 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.”

• In the said rules, in rule 19C, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31^st May, 2022, thereafter it shall be mandatory for all registration holders”.

• In the said rules, in rule 19D, in sub-rule (2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 28^th February, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31^st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number shall be generated which will remain valid up to the 31^st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.                          

Explanation.—For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31^st May, 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.”

5. In the said rules, in rule 19E, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31^st May, 2022, thereafter it shall be mandatory for all registration holders”.

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