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

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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India Postpones Registration Requirements for Certain Medical Devices

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With the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.

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Asia Actual Launches Online Medical Device Approval Search Service

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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. 

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The Philippines FDA Releases List of VAT Exempt Therapeutic Products

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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.”

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India to Require All Medical Devices be Registered Before Importation

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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.

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VietNam Expedites Registration of COVID-19 Related Medical Devices

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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.

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India’s CDSCO Updates Classification of Several Product Categories

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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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India Temporarily Suspends Compulsory Medical Device Registrations

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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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India Establishes Committees to Streamline Regulatory Framework and Address Denovo Products

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The Indian government has established 2 committees to help streamline the regulatory framework and establish denovo guidance.

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