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

Philippines FDA Publishes Revised Draft of New IVD Regulations

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The Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD Regulations along with a definitive timeline for implementation.

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Philippines’ FDA Issues Customs Clearance Guidance for Radiation Products

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On June 3, 2022, the Philippines’ FDA issued Circular No.2017-013-A: amendment To FDA Circular No. 2017-013, titled, “Guidelines On The Issuance of Clearance for Customs Release (CFCR) of Radiation Devices by the Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR).” The amendment updates the guidance to align FDA Circular 2017-013 with DOH AO 2018-0002 and to help clarify the Clearance for Customs Release (CFCR) requirements for the industry and at the Bureau of Customs (BOC) for radiation products.

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China Issues Recommendation for Medical Device Clinical Data

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For medical device registration in China, one of the most important documents to be provided is  clinical data. 

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NMPA Issues New Guidance for Medical Device Software in China

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In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.

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TFDA Updates Review Timelines for Medical Device Applications

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A Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.

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Philippines FDA Issues New Guidance for Vet Products

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The Philippines FDA released an advisory stating veterinary products and medical devices will now be handled exclusively by the CDRR.

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Philippines Extends Grace Period for Registration of Certain Medical Devices

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The Philippines FDA released a draft Circular announcing an extension of the grace period for certain medical devices by 12 months.

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TFDA Implements New Annual Reporting Requirements in Thailand

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On June 1, 2022, the Thai FDA released Gazette 138, Section 118 requiring license holders submit annual reports by March 30th of every year.

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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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