Local Authorised Representative (LAR)
What is a LAR?
A Local Authorised Representative (LAR) is a legal entity or individual established in Malaysia appointed by a foreign manufacturer to act on their behalf for all regulatory purposes relating to medical devices in Malaysia.
The LAR is the regulatory interface between the foreign manufacturer and MDA. All registration applications, correspondence with MDA, and regulatory obligations are channelled through the LAR.
Legal Basis
The LAR requirement is established under Act 737 and the Medical Device Regulations 2012. A foreign manufacturer cannot place a medical device on the Malaysian market unless a LAR has been formally appointed and holds the appropriate establishment licence.
Who Can Act as a LAR?
A LAR must be:
- A legal entity (company) registered in Malaysia (registered with SSM)
- Holding a valid establishment licence from MDA
- Not the foreign manufacturer itself — must be a separate Malaysian entity
- Capable of fulfilling all regulatory responsibilities
Typical LAR entities include:
- Malaysian subsidiaries of the foreign manufacturer
- Independent regulatory affairs companies
- Trading companies or distributors appointed with additional LAR responsibilities
LAR Appointment
The appointment must be formalised through a written agreement (LAR Agreement) between the foreign manufacturer and the Malaysian LAR. The agreement must:
- Clearly identify both parties
- Define the scope of products covered
- Grant the LAR authority to act on the manufacturer's behalf with MDA
- Obligate the manufacturer to provide all necessary documentation
- Include provisions for termination and transition
A copy of the LAR agreement is required as part of the establishment licence and device registration applications.
Responsibilities of the LAR
The LAR bears significant legal responsibilities in Malaysia:
| Responsibility | Detail |
|---|---|
| Device registration | Submit and maintain device registrations via MyMDA |
| Regulatory correspondence | Respond to MDA queries on behalf of manufacturer |
| Technical documentation | Hold or have access to all technical documentation |
| Post-market surveillance | Implement PMS activities in Malaysia |
| Adverse event reporting | Report serious incidents to MDA |
| FSCA management | Implement recalls and field safety corrective actions |
| Label compliance | Ensure labelling meets Malaysian requirements |
| Vigilance | Act as point of contact for MDA vigilance activities |
Responsibilities of the Foreign Manufacturer
The foreign manufacturer must:
- Provide the LAR with all technical documentation required for registration
- Inform the LAR promptly of any safety-related information, incidents, or FSCAs
- Maintain the quality system required for device class
- Cooperate with MDA inspections (via the LAR)
Termination of LAR Appointment
If the LAR appointment is terminated:
- The foreign manufacturer must appoint a new LAR before the existing appointment ends
- The new LAR must apply to transfer device registrations
- Devices cannot be supplied during a period with no appointed LAR
- MDA must be notified of any LAR change
The LAR can be held liable under Malaysian law for non-compliance with Act 737. Before accepting a LAR appointment, conduct thorough due diligence on the foreign manufacturer's quality and compliance systems.