Medical Devices – Asia and ROW Regulatory News – March 2023

JAPAN (PMDA)

Medical Safety Measures for Pharmaceuticals and Medical Devices

The Ministry of Health, Labour and Welfare (MHLW) continues efforts to reduce medical accidents by improving the naming, packaging, and specifications of pharmaceuticals and medical devices. Based on committee discussions, MHLW will implement new measures designed to minimize risks associated with product use in clinical settings.

Humanitarian Clinical Trials in Japan

The PMDA will publish information on primary clinical trials and humanitarian (expanded access) clinical trials submitted as clinical trial protocols. Updated monthly, this information includes:

• Main clinical trial listings 
• Humanitarian clinical trial listings 
• Contact information for clinical trial notifiers 

TAIWAN (TFDA)

Guidelines for Evaluating Gender Differences in Medical Device Clinical Trials

TFDA has introduced guidelines recommending that manufacturers and research institutions account for gender differences in study recruitment, design, statistical analysis, interpretation, and reporting. These guidelines help strengthen evidence supporting the safety and effectiveness of medical devices.

Amended Administrative Fee Standards for Medical Devices

TFDA has revised administrative fee standards covering:

• Inspection and registration 
• Changes and extensions of licence items 
• Licence collection, reissuance, and renewal 
• Registration, annual declarations, and updates 
• Clinical trial applications 

Details are available on the TFDA website.

INDIA (CDSCO)

Registered Notified Bodies under MDR 2017

CDSCO has updated the list of notified bodies authorized to audit manufacturing sites under MDR 2017.

Medical Device Testing Laboratories (MDTL)

CDSCO published an updated list of MDTLs registered to perform testing on behalf of manufacturers under MDR 2017 (Form MD-40).

SOUTH KOREA (MFDS)

MFDS Supports Global Expansion of Korean Medical Devices

At the Global Harmonization Working Party (GHWP) annual meeting, MFDS strengthened international regulatory cooperation and advanced discussions on adopting Korean guidelines—particularly its AI-based histopathologic IVD device review guidelines—as international standards.

MALAYSIA (MDA)

Classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices

MDA issued guidance on determining whether rehabilitation, physiotherapy, and speech therapy products qualify as medical devices based on their intended purpose and mode of action under the Medical Device Act 2012.

CHINA (NMPA)

Guidelines for Dental Adhesives and Artificial Shoulder Prostheses

NMPA released two guidelines:

• Dental adhesive products for restorative and prosthetic bonding 
• Artificial shoulder prostheses, including typical components and materials 

Notice on Soliciting Proposals for 2024 Medical Device Clinical Evaluation Standards

NMPA is soliciting proposals for 2024 standard-development projects related to clinical evaluation and clinical trial quality management.

CMDE Timelines for Supplementary Information

Updated timelines for submitting additional information:

• Notices issued before Feb 20, 2023: deadline extended by one year 
• Notices issued on/after Feb 20, 2023: one-year submission deadline reinstated 

Unique Device Identification (UDI) – Third Batch Implementation

A new batch of second-class medical devices will be required to implement UDI as part of ongoing reforms to strengthen device oversight.

SINGAPORE (HSA)

GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs)

HSA published guidance for clinical laboratories developing LDTs for use within the same facility. LDTs fall under the definition of IVD medical devices and must comply with requirements outlined in the Health Products Act and Medical Device Regulations.

MEXICO (COFEPRIS)

Warning on Counterfeit Human Tech Spine GmbH Devices

COFEPRIS issued an alert regarding counterfeit orthopedic implants, noting discrepancies such as incorrect labeling, missing engravings, poor-quality text, and nonexistent catalogue references.

KAZAKHSTAN (NDDA)

Revisions to Quality Assessment Requirements

Amendments define documents required to confirm the quality of medicinal product batches and medical devices. Updates also clarify reagent supply, test verification, and additional timelines for resolving conflicting laboratory results.

PAKISTAN (DRAP)

Amendment to Medical Devices Rules 2017 – SRO 224(I)/2023

DRAP announced exemptions from registration and enlistment requirements for certain medical devices for a defined period. Stakeholders are invited to submit comments on proposed amendments within 14 days of publication.

MALAYSIA (MDA)

Notification of Custom-Made Medical Devices

Guidance has been issued outlining requirements for custom-made medical devices eligible for exemption under the Medical Device (Exemption) Order 2016.

Launch of BayarNow Online Payment System

MDA introduced “BayarNow,” an online payment and billing platform integrated with the national GRP Financial System, allowing customers to make real-time FPX payments instead of bank drafts.