Malaysia: Diagnostics

Primary Regulatory Agency

Medical Device Authority

Major Functions

Formed in September 2005. Functions to oversee approval, registration, licensing, and monitoing of medical devices. 13 positions are currently filled in the organization. 

 Organizational chart

Relationship to Ministry of Health

Under the Ministry of Health

Key Contacts

Chief Executive
Mr. Mohd Zulhisham  
Level 5, Menara Prisma, No. 26, Jalan Persiaran Perdana Precint 3
62675 Putrajaya, MALAYSIA
Tel  : +603-8892 2400
Fax : +603-8892 2500
E-mail: mdb@mdb.gov.my

Contact Page

Relevant Regulatory Harmonization Initiatives

Regulatory framework is based on trends promoted by the Global Harmonization Task Force (GHTF), Asian Harmonization Working Party (AHWP) and Medical Device Product Working Group (MDPWG) of the ASEAN Consultative Committee for Standards and Quality (ACCSQ) and supported by the World Health Organization (WHO). The  ASEAN Medical Device Directive will be fully implemented by member states by January 1, 2015.

List of international standards for medical devices can be found here.

Known Collaborations with WHO

Collaborating Center in WHO's medical devices network. Participant in WHO's 2013 Global Forum on Medical Devices.

Common Technical Document (CTD) Acceptance

Common Submission Dossier Template

CMC Requirements

Design and manufacturing requirements can be found at the Guidance on the Essential Principles of and Performance of Medical Devices.

Standard Notification of Changes

News and Events page.

Clinical Trial Data Requirements

Conformity Assessment is the term given for the evaluation and approval process for medical devices. Details can be found in the "Placement of Medical Devices on the Malaysian Market." The Common Submission Dossier Template is required.

More information on Conformity Assessment can be found in the guidance document Principles of Conformity Assessment for In-Vitro Diagnostic Medical Devices.

Classification of Medical Devices:
-A, risk level: low
-B, risk level: low-moderate
-C, risk level: moderate-high
-D, risk level: high

Principles of Medical Devices Classification provides examples of classification.

Precedent (Clinical Trials Approved/Denied in Last 2 Years)

3 clinical trials approved from July 2012 to July 2014.

Product Registration Data Requirements

Guidance for how to apply for medical device registration under Medical Device Act 2012  (Act 737) can be found here.

Application must be done online through the MeDC@St system. The new application form consists of 8 parts:
1) General information
2) Manufacturer information
3) Medical device grouping
4) Common Submission Dossier Template (CSDT)
5) CSDT supporting documents
6) Post-market vigilance history
7) Declaration of Conformity
8) Attestation for medical device registration application

Product Registration Costs

A full list of fees can be found here.

Product Registration Process for Products Approved by SRA/WHO

According to this presentation by the Medical Device Authority, abridged registration available for devices already approved in the US, EU, Canade, Australia, and Japan. 

Post Registration Labeling Requirements

Malaysia follows the former Global Harmonization Task Force's labelling guidance. The guidance is available here.

In-Country Manufacturing Requirements

See CMC Requirements.

Post Registration Pharmacovigilance Requirements

The Conformity Assessment requires that a manufacture have a system for post-marketing surveillance to make sure a product continues to comply with the Essential Principles of Safety and Performance. This involves handling of complaints, post market vigilance reporting and subsequent corrective and preventive actions.

Additional information on adverse incident reporting is available here.

Last Updated

August 6, 2014.