Vietnam Requires Resubmission of Many Medical Device Registration Applications
All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.
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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 process in Vietnam.
The scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).
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.
The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
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.
The Indian government has established 2 committees to help streamline the regulatory framework and establish denovo guidance.