Primary Regulatory Agency
Formed in September 2005. Functions to oversee approval, registration, licensing, and monitoing of medical devices. 13 positions are currently filled in the organization.
Relationship to Ministry of Health
Under the Ministry of Health
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
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
Design and manufacturing requirements can be found at the Guidance on the Essential Principles of and Performance of Medical Devices.
Standard Notification of Changes
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.
August 6, 2014.