In Country Representation

Local Authorised Representative (LAR)

Manufacturers located outside of Malaysia, wishing to sell in Malaysia, must have a local authorised representative (LAR) representing them. This is a mandatory requirement. We can act for you, register your medical devices with the Medical Device Authority (MDA), hold your product licences and help ensure your products are compliant with local laws and regulations. We can also assist you with any post market activities which may be required, for example reporting any incidents or field safety corrective actions involving the medical devices we represent to the competent authorities. We also keep you up to date with local changes and new developments as new regulatory intelligence becomes available so you stay ahead of industry changes.

Contact Point

The LAR role is an important regulatory role – we serve as your contact point with MDA, ensures your product compliance with local regulatory requirements, keep your importers and distributors up to date with your product registration certificates. Thus appointing the right partner is crucial. Our service goes beyond the obligations of Act 737 and the Medical Device Regulations 2012, we provide you with professional advice and support for your medical device regulatory

Post Market Activities

As your LAR, we can assist with complaints handling and adverse events reporting. Sometimes situations can occur which require a manufacturer to carry out field safety measures such as safety notifications or corrective actions or even product recalls. We can provide advice based on local requirements and act as your liaison with MDA to resolve issues.

Consulting Service for Medical Device in Malaysia

Searching for a Local Authorised Representative?

We only undertake regulatory services and do not import nor distribute products so will be the ideal partner to hold your product licences.