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- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
/in China, India, Japan, Latest Updates, South Korea, Taiwan, United States/by Albert PranotoAn outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
India Issues New Sales License Requirement for Medical Devices
/in India, Latest Updates/by Gunjan VermaOn September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.
Expedited Market Access Now Available in Philippines
/in Latest Updates, Philippines/by Charmaine RosonOn 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.
India Grants Import License Grace Period for Class A/B Devices
/in India, Latest Updates/by Gunjan VermaReleased 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.
India Issues Draft Notification for Exempting Certain Class A Medical Devices
/in India, Latest Updates/by Gunjan VermaThe 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.
Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR
/in Latest Updates, Philippines/by Charmaine RosonAnnounced 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.
Vietnam’s DMEC Provides Update on Issuance of C/D Licenses
/in Latest Updates, Vietnam/by David VoOn September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.
Philippines FDA Publishes Revised Draft of New IVD Regulations
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD Regulations along with a definitive timeline for implementation.