All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.
This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.
With the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.
The MOH officially released Decree 98/2021 ND-CP, which implements significant new changes to the medical device registration in VietNam.
The Thai FDA has formally adopted the Regulatory Reliance Program in which Class D (Class 4 in Thailand) medical devices and IVDs listed on the Singapore Medical Device Registry can be exempted from the Specialist Review requirement in Thailand.
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.
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- Vietnam Requires Resubmission of Many Medical Device Registration Applications January 10, 2022
- China to Accept Foreign Generated Test Reports December 7, 2021
- India Postpones Registration Requirements for Certain Medical Devices November 18, 2021
- VietNam Releases New Medical Device Regulations November 16, 2021
- Thailand Fast Tracks Class D Medical Device Registration with Singapore Approval Status October 25, 2021
- 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