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

Registering Innovative Medical Devices in India

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Innovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.

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China NMPA Updates Classification of Sodium Hyaluronate Products

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On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.

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China Releases Draft Clinical Evaluation Exemption List for 2022

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On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.

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India Requires Mandatory Local BIS Certifications for Certain Medical Devices

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This blog serves as an important enforcement notice for manufacturers/importers that BIS certification is required for some of the electronic components/accessories included in medical devices, including batteries, monitors, power adaptors and more.

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UDI Labelling Mandatory for Certain Taiwan Medical Devices

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In Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.

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India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline

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On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.

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Vietnam’s DMEC Provides Update on Issuance of C/D Licenses

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On September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.

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The Vietnamese MOH Issues Draft Decree to Address Delays

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On November 15th, the Vietnamese Ministry of Health (MOH) issued a draft decree to amend a number of articles from a previous decree related to the registration of medical devices.

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Vietnam Extends Validity of Medical Device Import Licenses

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On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.

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Thailand FDA Publishes Guidance for Software as Medical Device

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On December 12th, the Thai FDA published guidance to assist with the determination of medical device status and risk classification for medical device software in Thailand.

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