On October 7, 2021, the Philippines FDA released FDA Circular No.2021-0021. The new regulations apply to establishments that provide medical devices Direct to Consumers (DTC) including pharmacies and eCommerce storefronts.
On September 30, 2021 the Thai FDA published (reference Gazette Volume 138, Special Section 239N) a revised fee schedule covering medical and diagnostic device registration applications, license establishments, quality systems, and other review processes.
In public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date.
With the release of Circular 13/2021/TT-BYT on September 16, 2021, the VietNamese Ministry of Health has provided a new, expedited review process for specified medical devices related to COVID-19.
On September 21, 2021, the CDSCO released the Guidance Document for Registration of Non Notified Medical Devices to provide additional clarity as the Voluntary registration deadline approaches on September 30, 2021.
On September 14th, the Philippines FDA released FDA Advisory No.2021-2293, outlining the list of VAT-Exempt Products pursuant to Republic Act No. 11534, otherwise known as the “Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act.”
Asia Actual is excited to launch R.O.S.E., the Registration Optimized Search Engine. The goal of R.O.S.E. is to provide centralized access to medical device registration data in Asian markets.
the FDA has released a list of Class A 1,242 product categories in Circular 2021-017 on August 16, 2021. Medical device manufacturers of Class A products specified in Annex A or under the ASEAN MDD, must obtain a Certificate of Medical Device Notification (CMDN).
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- The Philippines FDA Issues Guidance for Retailers of Medical Devices October 15, 2021
- Thai FDA Updates Medical Devices Applications Fees October 15, 2021
- India Temporarily Suspends Compulsory Medical Device Registrations October 5, 2021
- VietNam Expedites Registration of COVID-19 Related Medical Devices October 4, 2021
- India to Require All Medical Devices be Registered Before Importation September 23, 2021
- The Philippines FDA Releases List of VAT Exempt Therapeutic Products September 22, 2021
- Asia Actual Launches Online Medical Device Approval Search Service September 16, 2021
- Philippines Releases New Guidance on Class A Medical Devices August 24, 2021
- Philippines Extends Grace Period for Non-Notified Class B, C, and D Medical Device Registration August 18, 2021
- Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices July 7, 2021