Draft The Medical Devices (.........Amendment) Rules, 2022

Sep 20, 2022 | by TeamLease RegTech Legal Research Team

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Industry Specific ComplianceThe Ministry of Health and Family Welfare (MoHFW) on September 20, 2022, notified a Draft The Medical Devices (.........Amendment) Rules, 2022 to amend the Medical Device Rules, 2017 further.

The amendments are as follows-

•After CHAPTER IIIA, the following CHAPTER IIIB REGISTRATION OF CLASS A (NON-STERILE and NON-MEASURING) MEDICAL DEVICES shall be inserted.

•In the said rules, in the Eighth Schedule, in the table under the heading “Extent and conditions of exemption”, after S.N. 7, entries 8 and 9 shall be inserted.

The said draft rules shall be considered on or after the expiry of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.

[Notification No. G.S.R. 710(E)]


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