Local Authorised Representative

Many countries require foreign manufacturers to have a Local Authorised Representative (LAR) in Southeast Asia if they don’t set up a foreign subsidiary. Also called an in-country representative, local agent, or marketing authorization holder, the LAR is the regulatory contact for medical devices or IVDs. They handle all interactions with local medical device authorities, including product registrations, import and distribution licenses, change notifications, post-market surveillance, adverse events, and product recalls.

Local Authorised Representative Southeast Asia

While the appointment of a Local Authorised Representative (LAR) ASEAN does not change the manufacturer’s responsibilities, the LAR must be carefully selected and supervised. Regulations often do not detail the role and obligations of a LAR, so it is crucial to set up a contract specifying the tasks and authority delegated to the LAR. The chosen LAR must understand the regulatory requirements of the country to act in the manufacturer’s best interest.

What Our Local Authorised Representative Can Do For You

How Andaman Medical Can Help You with In-Country Representation

With local offices in the seven major markets throughout Southeast Asia, Andaman Medical offers in-country representation services for the following countries:

Why Andaman Medical Is Your Ideal Medical Device (MD) Compliance Consultancy

With a deep understanding of both local and international regulations, we provide comprehensive support to ensure your products meet all necessary standards. Here’s what we can do for you:

Ensuring compliance with labelling and packaging regulations

Risk management and assessment services

Preparation of technical files and design dossiers

Conducting compliance audits and gap analysis

Preparation of technical files and design dossiers

Market access strategy and support

Monitor and report on any regulatory changes to ensure ongoing compliance

Why Choose Andaman Medical?

Get Expert Help Today

Contact us today to discuss how Andaman Medical can be your trusted partner for Local Authorised Representative in Southeast Asia. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
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