UDI overview in Asia

Marked by strong economic development, Asian countries are gradually implementing UDI and regularizing their regulatory environment for medical devices. It is therefore smart to know where these countries are in their regulatory progress.

That’s why we provide here an overview of the main information regarding 15 Asian countries.

Most of these countries have regulations in lines with the Medical device Directive (AMDD) of the ASEAN (Association of Southeast Asian Nations). Note that in any cases, foreign companies must appoint an Authorized Representative (AR) to apply for registration and to delegate certain responsibilities, depending on the country.

As there are many specificities for each country, we do not go into details but provide the official link for more information.

Explanation of abbreviations:

• UDI: Unique Device Identification
• CSDT: Common Submission Dossier Template. This document is intended to provide a common template for the submission of medical device information to authorities of ASEAN member countries. See the ASEAN guidance here.
• GHTF:  Global Harmonization Task Force

	Country	Authority	Classification (Low-High)	State of the UDI Regulation link
	Bangladesh	Directorate General of Drug Administration (DGDA)	A, B, C, D	UDI not implemented Registration requirements based on the GHTF documents. More information here.
	Cambodia	Department of drugs and Food (DDF)	A, B, C, D	UDI not implemented ASEAN AMDD Member. Technical documentation according to the CSDT. More information here.
	China	National Medical products Administration (NMPA)	I, II, III	UDI implemented Approval in the home country´s market is needed for registration. More information here.
	India	Central Drugs Standard Control Organization (CDSCO)	A, B, C, D	UDI will be mandatory for all medical devices sold in India, starting on January 1st, 2022 Approval in the home country´s market is needed for registration. More information here.
	Indonesia	Ministry of Health (MoH)	A, B, C, D	UDI not implemented ASEAN AMDD Member. Technical documentation according to the CSDT. Based on the type of product, the risk class must be determined independently. More information here.
	Japan	Ministry of Health, Labor, and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA)	I, II, III, IV	UDI implemented Companies must comply with the Pharmaceuticals and Medical Devices Act (PMD Act). Japan registration process is known to be especially long, costly and complicated. More information here.
	Laos	Ministry of Health (MoH)	A, B, C, D	UDI not implemented ASEAN AMDD Member. More information here.
	Malaysia	Malaysian Medical Device Authority (MDA)	A, B, C, D	UDI not implemented ASEAN AMDD Member. Simplified registration process for devices already approved in the US, European Union, Australia, Japan or Canada. More information here.
	Myanmar	FDA of Myanmar	A, B, C, D	UDI not implemented ASEAN AMDD Member. More information here.
	Pakistan	Drug Regulatory Authority of Pakistan (DRAP)	A, B, C, D	UDI not implemented More information here.
	Philippines	Food and Drug Administration of the Philippines (FDA)	A, B, C, D	UDI not implemented ASEAN AMDD Member. More information here.
	Singapore	Health Sciences Authority (HSA)	A (Non-sterile), A (sterile), B, C, D	UDI will be mandatory for Class B, C, D medical devices, starting in 2022 for high risk implantable devices Check out this guidance for more information.ASEAN AMDD Member.More information here.
	South Korea	Ministry of Food and Drug Safety (MFDS)	I, II, III, IV	UDI implemented Machine-to-machine submission possible. More information here.
	Thailand	Medical Device Control Division (MDCD)	1, 2, 3, 4	UDI not implemented Member of the ASEAN AMDD. More information here.
	Vietnam	Department of Medical Equipment and Health Works (DMEHW)	A, B, C, D	UDI not implemented ASEAN AMDD Member. More information here.

→ We published an overview of the UDI worldwide (state July 2021) for 9 countries. Check out the article:

UDI World Overview July 2021 status