2023-07-18T04:58:01
19D. (1) Any person who imports any medical device referred in rule 19A shall upload the following information relating to that medical device for registration on the "Online System for Medical Devices" established by the Central Drugs Standard Control Organisation for this purpose.
(2) The importer shall upload, —
(i) name of the company or firm or any other entity importing the medical device and specification and standards of that medical device, (ii) Details of medical device
Generic
Name
Model
No.
Intended
Use
Class of
Medical
device
Material of
Construction
Dimension
(if any)
Shelf
Life
Sterile
or
NonSterile
Brand Name
(if registered
under the
Trade Marks
Act, 1999)
(iii) certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device: 9 [PROVIDED that in case the applicant submits, on or before the 28th February, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st 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 31st 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.
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