Importer Licence
Who is an Importer?
An importer is any natural or legal person established in Malaysia who places a medical device from a foreign manufacturer onto the Malaysian market in their own name or under their own brand — or who imports devices for onward supply to distributors or end users.
Licence Requirements
| Requirement | Detail |
|---|---|
| Malaysian legal entity | Must be registered with SSM |
| Physical address | Office/warehouse in Malaysia |
| QMS | Appropriate quality system for import activities |
| Written agreements | Formal agreement with foreign manufacturer |
| Product knowledge | Technical documentation access |
Importer vs LAR
The roles of importer and Local Authorised Representative (LAR) are closely related but distinct:
| Aspect | Importer | LAR |
|---|---|---|
| Primary role | Brings goods into Malaysia for supply | Represents foreign manufacturer to MDA |
| Regulatory responsibility | Compliance of imported devices | Regulatory submissions and compliance on behalf of manufacturer |
| Can be same entity? | Yes — often the importer also acts as LAR | Yes |
Many entities in Malaysia hold both roles for the same foreign manufacturer.
Quality System Requirements
Importers must maintain quality procedures covering:
- Incoming goods inspection and verification
- Storage conditions appropriate to device requirements (temperature, humidity)
- Traceability of products — batch numbers, expiry dates, quantities
- Complaint handling procedures
- Adverse event reporting procedures
- Recall and FSCA procedures
Importers do not typically need full ISO 13485 certification but must have documented procedures consistent with good distribution practice.
Responsibilities of the Importer
- Verify the device is registered with MDA before import and supply
- Verify the foreign manufacturer holds appropriate QMS certification
- Maintain records sufficient to trace products to their destination
- Report serious adverse events to MDA
- Cooperate with MDA inspections and audits
- Implement recalls and FSCAs as directed by the manufacturer or MDA
Documentation Required for Application
- SSM registration documents
- Physical address evidence (tenancy agreement, utility bill)
- Organisational chart and responsible person details
- List of devices to be imported (or device categories)
- Evidence of agreements with foreign manufacturers
- QMS procedure overview
Annual Renewal
Importer licences are renewed annually via MyMDA. Updated documentation required only if material changes have occurred.
Most foreign market entry strategies in Malaysia involve one local entity acting as both the importer and the LAR. This simplifies regulatory responsibility and reduces the number of licences to manage.