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

Hong Kong Refines Medical Device Post-Market Surveillance Report Form

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On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.

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Thailand FDA Provides Guidance on Classification of Physical Therapy Devices

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On December 3rd, 2022, the Thailand FDA (TFDA) issued new regulation to re-classify Physical Therapy Devices as Class 1 medical devices.

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India Issues New Sales License Requirement for Medical Devices

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On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.

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Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices

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On December 29th, 2022 the Philippines FDA (PFDA) issued an advisory reiteration concerning unethical business practices, specifically in regards to companies that sell/manufacture Prescription Pharmaceutical Products and Medical Devices (PPPMD) and their relationship/interaction with healthcare professionals (HCPs).

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Indonesia e-Catalogue Implementation Review, December 2022

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On April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.

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Indonesia Revamps eCatalogue Procurement System

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On February 11th and 14th, the Ministry of Health of the Republic of Indonesia implemented significant structural and procedural changes to the government procurement system known as e-Catalogue as it applies to medical devices (reference announcement KN.01.04/3/630/2022). Under the new rules, oversight of the e-Catalogue has been moved under the Ministry of Health and will not require negotiations.

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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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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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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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China NMPA Updates Compulsory Standards for Medical Devices

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On November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year.

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