On September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.
Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.
The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.
Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.
On September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.
The Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD Regulations along with a definitive timeline for implementation.
The Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.
Hong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.
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