Malaysia–China Medical Device Regulatory Reliance Programme: Pilot Phase I (30 July – 30 September 2025)

The Medical Device Authority (MDA) of Malaysia has officially launched the Malaysia–China Medical Device Regulatory Reliance Programme, marking the first reciprocal regulatory arrangement of its kind worldwide under the Global Harmonization Working Party (GHWP) framework. This pilot programme is a groundbreaking step in international regulatory collaboration, aimed at accelerating market access for high-quality, safe, and effective in-vitro diagnostic (IVD) medical devices.

This bilateral initiative stems from a Memorandum of Understanding (MoU) signed in November 2023 between Malaysia’s MDA and China’s National Medical Products Administration (NMPA). Both authorities agreed to mutually recognize certain regulatory decisions for IVD medical devices, significantly reducing duplication in evaluations and fostering trust between regulatory systems.

Regulatory Reliance involves one regulatory authority leveraging the work products, decisions, or assessments of another trusted regulator to expedite product reviews and approvals. This approach avoids duplicative evaluations, reduces time-to-market, and fosters mutual trust between agencies.

• In this initiative: Malaysia and China mutually recognize regulatory decisions for selected IVD medical devices, streamlining access to markets in both countries.

• In-Vitro Diagnostic (IVD) Device: Medical device, whether used alone or in combination, intended for the in-vitro examination of specimens derived from the human body.

• Verification Pathway (Malaysia): A regulatory route that allows certain foreign-made devices to be verified and registered more quickly due to recognition of the original regulatory approval (here, Chinese approvals).

• Green Channel (China): Special accelerated regulatory pathway for fast-tracking review/approval of innovative or urgently needed medical devices

The programme will run from 30 July to 30 September 2025, focusing on:

• Enhancing regulatory efficiency

• Accelerating market entry for eligible IVD medical devices in Malaysia and China

• Strengthening international regulatory reliance

• Prioritising access to innovative and rare disease-related medical technologies

Submission Process for Chinese-Made IVD Devices (Malaysia’s Verification Pathway)

Step 1: Appoint a licensed Authorised Representative (AR) in Malaysia with a valid Establishment License (Act 737).

Step 2: AR submits Premarket Documentation to MDA for eligibility screening. Required documents include:

• Quality Management System (QMS) certificates (ISO 13485, MDSAP, FDA QSR, Japan MHLW)

• Medical Device Information (name, intended use, classification, grouping)

• CSDT Documentation (Executive Summary, Essential Principles of Safety and Performance, design verification & validation, clinical performance data, labelling, IFU, risk analysis, manufacturing details)

• Post-Market Surveillance Plan

• Declaration of Conformity (DoC)

• Regulatory Approval (Class II or III certificates from China)

Step 3: MDA appoints a Conformity Assessment Body (CAB) for verification assessment.

Step 4: CAB conducts assessment and issues a certificate upon satisfactory review.

Step 5: AR submits a Medical Device Registration Application via the MeDC@St system.

Step 6: MDA evaluates and issues a registration certificate valid for 5 years.

📌 For full official requirements, detailed submission instructions, and contact information, please read the announcement and appendix directly:

• Implementation of the Malaysia–China Medical Device Regulatory Reliance Programme—Pilot Phase I (MDA Document, PDF)