A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
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.
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.”
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.
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.
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.
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.
The Indian government has established 2 committees to help streamline the regulatory framework and establish denovo guidance.
During this transition period, Class B, C, and D medical devices that are not included in the specified list in Circular No. 2021-001-A may continue to be manufactured, imported/exported, distributed, and/or sold without a CMDN until March 31, 2022.
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 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.
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