A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

Vietnam Releases New Medical Device Regulations

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The MOH officially released Decree 98/2021 ND-CP, which implements significant new changes to the medical device registration process in Vietnam.

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Thai FDA Streamlines Medical Device Registration Process

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The TFDA will adjust the registration process and remove the initial pre-submission step beginning March 15, 2022. Beginning April 1, 2022, any classification and/or grouping questions can be submitted through a separate E-submission process for a 500 THB (US$15) fee each.

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Thai FDA Updates List of Chemical Pollutants

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The TFDA has updated their list of chemical pollutants to comply with the Stockholm Convention on Persistent Organic Pollutants.

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Hong Kong’s MDD Formalizes Expedited Approval Scheme

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Hong Kong’s Expedited Approval Scheme has been upgraded from a trial. Approvals from at least 2 GHTF countries plus China.

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COVID Test Kits Now Require In-Country Testing in the Philippines and Indonesia

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At this time Indonesia’s Ministry of Health will only regulation Rapid Diagnostic Tests (RDTs) while the Philippines Department of Health will require testing for RDTs, along with other related products such as Nucleic Acid Extraction Kits and COVID-19 antibody tests. It’s expected that the process will require 1-2 months in each country.

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Taiwan FDA Increases Regulatory Fees for Medical Devices

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The Taiwan FDA has announced a price increase for many regulatory items, with some seeing an increase as much as 163%. This notice has been in effect since May 1st, 2021.

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Regulatory Spotlight: UDI Requirements in Singapore

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Singapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system.

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India Exempts COVID Test Kits Approved in Reference Countries from Validation Testing

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As of April 27th, India’s CDSCO will allow COVID test kits with the following approvals to bypass in-country validation testing. Previously only tests approved by the USFDA (including Emergency Use Authorization) were exempt

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Thai Requirements for COVID Test Kits

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Similar to other markets in the region, manufacturers of COVID test kits will need to undergo in-country validation as part of the Class 4 Licensing process in Thailand.

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VietNam’s MOH to Require CSDT Documentation for Class B, C, and D Devices

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On May 15, 2021, the VietNamese Ministry of Health (MOH) released new Guidance announcing Class B, C, and D devices will need to submit their applications in accordance with the ASEAN Common Submission Dossier Template (CSDT) format.

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