The Ministry of Health and Family Welfare vide notification dated January 18, 2022, has issued the Medical Devices (….. Amendment) Rules, 2022 further amending the Medical Devices Rules, 2017.
The following amendment has been made:
· A new proviso shall be inserted in item (iii) in sub-rule (2), of rule 19B which reads as- Provided 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 a 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 May 31, 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.
· Rule 19C shall be substituted which reads as- After furnishing of the above information on the “Online System for Medical Devices” established by Central Drugs Standard Control Organisation for this purpose by the applicant's registration number will be generated. The manufacturer may, if so desired, mention the registration number or provisional registration number for a period up to May 31, 2022, thereafter it shall be mandatory for all registered holders.
· A new proviso shall be inserted in item (iii) in sub-rule (2), of rule 19D which reads as- Provided 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 a 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 May 31, 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.
· Rule 19E shall be substituted which reads as- After furnishing of the above information on the “Online System for Medical Devices” established by the Central Drugs Standard Control Organisation for this purpose by the applicant's registration number will be generated. Importers may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to May 31, 2022, thereafter it shall be mandatory for all registered holders.
(Notification no: G.S.R. 19(E))
