Manufacturer Licence
Who is a Manufacturer?
Under Act 737, a manufacturer is any natural or legal person who:
- Designs and/or manufactures a medical device with the intention of making it available for use under their name
- Assembles or adapts a medical device for its intended purpose
- Performs significant sterilisation, packaging, or labelling of a device
This definition includes contract manufacturers who manufacture under another entity's brand.
Malaysian Manufacturers
A Malaysian company or individual manufacturing medical devices in Malaysia must obtain a manufacturer establishment licence from MDA.
Key Requirements
| Requirement | Detail |
|---|---|
| Legal registration | Must be registered with the Companies Commission of Malaysia (SSM) or equivalent |
| Physical premises | Must have a physical manufacturing site in Malaysia |
| QMS | ISO 13485-certified or equivalent GMP system |
| PRRC | Designated Person Responsible for Regulatory Compliance |
| Records | Maintain full manufacturing and batch records |
QMS / GMP Requirements
Malaysian manufacturers must maintain a Quality Management System (QMS) meeting the requirements of:
- ISO 13485:2016 — Medical devices — Quality management systems
- MDA's GMP guidelines for medical devices
- Malaysian Standard MS ISO 13485 (equivalent to international standard)
MDA conducts Good Manufacturing Practice (GMP) audits of licensed manufacturers. Manufacturers should be prepared for announced and unannounced inspections.
Documentation Required for Application
- Company registration documents (SSM)
- Site master file or site description
- ISO 13485 certificate (or equivalent QMS evidence)
- Organisational chart
- Details of manufacturing scope (device types)
- PRRC appointment letter and CV
- Site layout plan
Foreign Manufacturers
Foreign manufacturers cannot directly hold a Malaysian establishment licence. They must appoint a Local Authorised Representative (LAR) who acts on their behalf for all regulatory purposes in Malaysia.
The foreign manufacturer must:
- Appoint a Malaysian LAR via a formal written agreement
- Ensure the LAR has access to all technical and quality documentation
- Provide the LAR with authority to respond to MDA queries and manage recalls
See Local Authorised Representative for full LAR requirements.
Recognised Foreign Regulatory Systems
MDA recognises manufacturers holding current regulatory approvals or QMS certifications from recognised jurisdictions. MDSAP certificate holders may benefit from a streamlined QMS review. See MDSAP Recognition.
Annual Renewal
The manufacturer licence must be renewed annually. Renewal requires:
- Confirmation of continued QMS certification
- Updated responsible person information if changed
- Payment of renewal fee
- No material changes unreported to MDA
If a manufacturer licence lapses, all associated device registrations are at risk of suspension. Set reminders for annual renewal — the MDA portal sends notifications but do not rely solely on these.