Key Medical Device Regulatory Updates in Asia in 2023

Welcome to our comprehensive guide to the most crucial regulatory updates in Asia during 2023.

Bangladesh

Bangladesh Launches New Medical Device Regulations

10/17/2023

China

NMPA Adjusts Medical Device Classification Catalogue	9/19/2023
China NMPA Adds 47 Products to Clinical Trial Exemption List	8/22/2023
China to Regulate Medical Device Advertising	8/2/2023
China CMDE Supplementary Documents Submission Deadline Extended	4/11/2023
China Continues to Implement UDI of Medical Devices with Third Batch Release	3/16/2023

Hong Kong

MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong	12/7/2023
Hong Kong Government Prioritizes Purchase of Locally Registered Medical Devices	6/14/2023
Hong Kong Refines Medical Device Post-Market Surveillance Report	1/27/2023

India

CDSCO Issues Updates to IVD Classification List in India	11/30/2023
India Grants Import License Grace Period for Class C/D Devices	10/16/2023
New Plastic Wasste (PWM) Rules Affect Medical Device Importers in India	8/22/2023
An Introduction to GeM, India’s Online Portal For All Public Hospital Purchases	5/30/2023
India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline	4/21/2023
India’s CDSCO Releases Guidance for Renewing Medical Device Import Licenses	3/24/2023
India Requires Mandatory Local BIS Certifications for Certain Medical Devices	2/22/2023

Indonesia

Indonesia to Require In-Country Testing

10/11/2023

Philippines

Philippines FDA Extends CMDN Deadline to 2024	3/31/2023
Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies	2/7/2023
Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices	1/13/2023
Philippines FDA Announces New Fee Schedule For Medical Devices	12/15/2023

Taiwan

UDI Labelling Mandatory for Certain Taiwan Medical Devices

4/6/2023

Thailand

Thailand Releases Draft Guidance for Software and AI Registration	9/18/2023
TFDA Announces Key Updates to Medical Device Application Management System	6/27/2023
Thai FDA Issues Guidance on Specialist Review Criteria	2/16/2023
Thailand FDA Provides Guidance on Classification of Physical Therapy Devices	1/20/2023

Vietnam

Vietnam Adjustments to the Medical Device Application Requirements	6/6/2023
Vietnam Diagnostic Imaging Center Hosts AI Software Conference	5/11/2023
Vietnam Extends Validity of Medical Device Import Licenses	3/8/2023