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

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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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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India Announces New Notified Medical Devices Now Requiring Import Licenses

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After the voluntary period ends on October 2021, all class A and B non-regulatory medical devices will have 12 months (i.e., by October 1st, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1st, 2023) to meet the same requirement.

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India’s Public Hospitals Advised to Purchase Local Products

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On March 25, 2021, a notification was released specifying 19 more devices belonging to categories such as gloves, syringes, orthopedic products, x-ray machines, etc. that only local manufacturers could bid on.

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Philippines Announces New PEMDL Essential Medical Device List

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Notification AO 2021-0038 was released on June 11th, 2021 with the goal of creating a standardized system for determining and maintaining a database of essential medical devices, hereby known as the Philippine Essential Medical Device List (PEMDL). Additionally, the Medical Devices and Supplies Price Reference Index (MDSPRI) will also be established to provide more price transparency when it comes to medical devices in the Philippines.

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Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices

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Per Presidential Regulation 12/2021, the Ministry of Health (MOH) is requiring products with a Domestic Component Level (TKDN) and Benefit Weigh Value (BMP) of 40% or more be purchased by government hospitals regardless of available foreign products.

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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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