Establishment Licence Overview
What is an Establishment Licence?
Under Section 6 of the Medical Device Act 2012 (Act 737), any person who carries out an activity as a manufacturer, importer, or distributor of medical devices in Malaysia must hold a valid establishment licence issued by the Medical Device Authority (MDA).
An establishment licence is:
- Issued per establishment (physical site or business entity)
- Valid for 1 year from the date of issue
- Renewed annually
- A prerequisite for device registration — you cannot register a device without a valid establishment licence
Who Needs an Establishment Licence?
| Activity | Licence Type Required |
|---|---|
| Manufacturing medical devices in Malaysia | Manufacturer licence |
| Importing medical devices into Malaysia | Importer licence |
| Distributing medical devices within Malaysia | Distributor licence |
| Acting as Local Authorised Representative for a foreign manufacturer | LAR (treated as importer/manufacturer agent) |
Foreign manufacturers do not directly apply for a Malaysian establishment licence. Instead, they must appoint a Local Authorised Representative (LAR) in Malaysia who holds the licence on their behalf. See Local Authorised Representative.
General Requirements for All Licences
Regardless of licence type, all applicants must:
- Be a legally registered business entity in Malaysia
- Have a physical address in Malaysia
- Maintain a Quality Management System (QMS) appropriate to the activities performed
- Designate a qualified Person Responsible for Regulatory Compliance (PRRC) or equivalent responsible person
- Maintain records as required by MDA
Licence Conditions
MDA may attach conditions to an establishment licence, including:
- Restrictions on the types of devices covered
- Requirements to maintain specific quality standards
- Obligations to report specific events or changes
- Requirements to allow MDA inspection at any time
Consequences of Non-Compliance
Operating without a valid establishment licence is an offence under Act 737:
| Offence | Maximum Penalty |
|---|---|
| Operating without a licence | Fine up to RM 500,000 and/or imprisonment up to 3 years (first offence) |
| Continued offence | Fine up to RM 1,000 per day |
| Providing false information | Licence cancellation and prosecution |
Application Process
All establishment licence applications are submitted via the MyMDA portal. See MyMDA Portal — Establishment for a step-by-step guide.
Processing time: Approximately 30 working days for new applications; 14 working days for renewals.
Change Notification
Licence holders must notify MDA promptly of material changes, including:
- Change of business address
- Change of responsible person
- Change in scope of activities
- Change in company ownership or structure
- Cessation of activities