Question 1

What is MDA and why is it important for medical device companies?

Accepted Answer

MDA (Medical Device Authority) is Malaysia's national regulatory authority for medical devices under the Ministry of Health. MDA implements the Medical Device Act 2012 (Act 737), regulating medical devices, IVDs, and accessories in Malaysia's expanding medical device market. All medical device companies must obtain MDA registration through the MeDC@St system and maintain compliance to sell products in Malaysia.

Question 2

What is the Malaysia-China Regulatory Reliance Program?

Accepted Answer

The Malaysia-China Medical Device Regulatory Reliance Programme was launched in 2025 with Pilot Phase 1 running July 30 - September 30, 2025. This program enables expedited registration for devices with prior NMPA (China) approval by leveraging reference country technical assessments. It represents Malaysia's commitment to international regulatory harmonization and faster market access for pre-approved devices.

Question 3

What are the recent conformity assessment procedure updates?

Accepted Answer

On March 11, 2025, MDA implemented Circular Letter No. 1/2025 (superseding Circular Letter No. 2/2014) regarding conformity assessment procedures for devices approved by recognized foreign regulatory authorities. MDA Guidance Document MDA/GD/0068 Second Edition (September 2025) added Singapore HSA and Thailand FDA as recognized regulatory authorities, expanding the list of reference countries for verification pathways.

Question 4

How are medical devices classified in Malaysia?

Accepted Answer

Malaysia classifies medical devices as Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (highest risk), aligned with the EU classification scheme. Classification is based on intended use, duration of use, invasiveness, and whether the device is active or implantable. MDA provides guidance documents to assist manufacturers with proper device classification.

Question 5

What is MeDC@St and how does device registration work?

Accepted Answer

MeDC@St (Medical Device Centralised Online Application System) is MDA's web-based electronic registration platform. Per Section 5(1) of the Medical Device Act 2012, no device may be imported, exported, or placed on the market unless registered through MeDC@St. Only the local Authorized Representative can submit registration applications through the system.

Question 6

What is an Authorized Representative and do foreign manufacturers need one?

Accepted Answer

An Authorized Representative (AR) is a Malaysia-based legal entity required for foreign medical device manufacturers. The AR acts on behalf of the manufacturer in all regulatory interactions with MDA, including MeDC@St registration, post-market surveillance, and compliance activities. All foreign companies must appoint an AR to register and sell medical devices in Malaysia.

Question 7

How can I stay updated on MDA regulatory changes?

Accepted Answer

This page automatically aggregates MDA and Malaysia medical device news from 7 premium regulatory intelligence sources daily, including RAPS, Pacific Bridge Medical, Emergo by UL, Asia Actual, and others. Pure Global provides comprehensive regulatory support for Malaysia market access.

MDA News & Malaysia Medical Device Regulatory Updates 2025

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