Local Authorised Representative

Local Authorised Representative in Southeast Asia

Many Southeast Asian countries require foreign medical device and IVD manufacturers to appoint a Local Authorised Representative (LAR) if no local subsidiary is established. Also known as an in-country representative or local agent, the LAR serves as your official regulatory contact and is responsible for managing communications with national authorities throughout the product lifecycle.

At Andaman Medical, we act on your behalf to oversee essential regulatory functions across ASEAN. From product registration and import licensing to post-market surveillance, adverse event reporting, and recalls, our teams ensure your devices remain compliant and continuously supported in all markets where they are placed.

Why Is a Local Authorised Representative Important in Southeast Asia?

Appointing a LAR does not remove the manufacturer’s overall regulatory responsibilities, but the role is important for ensuring safe, compliant, and efficient market access across ASEAN. A well-chosen LAR provides key benefits, including:

Clear definition of regulatory duties, especially as many ASEAN regulations do not outline the specific tasks or authority of a LAR
Proper delegation and oversight, supported by a structured contract that clarifies responsibilities and reporting expectations
Local expertise in country-specific requirements, including submissions, vigilance systems, and approval conditions
Consistent regulatory compliance across multiple markets with differing frameworks
Smooth communication with authorities, helping prevent delays and ensure timely responses
Sustained product availability, supported by ongoing post-market obligations and regulatory updates

Partner with Andaman Medical as your Local Authorised Representative in Southeast Asia to maintain regulatory clarity, secure compliant market access, and support long-term commercial success.

What Our Local Authorised Representative Can Do For You

Regulatory Representation

Represent the manufacturer in all dealings with local medical device authorities, including:

Registering products
Obtaining import and distribution licences
Submitting change notifications
Transferring product licenses
Ensuring post-market surveillance, including handling adverse events and product recalls

Compliance Assurance

Ensure the appropriate conformity assessment procedure is carried out if required.

Labelling and Information

Ensure the medical device or IVD is correctly labelled and information is provided in the specified national language(s).

Authority Liaison

Accept all communications from local medical device authorities and coordinate with the foreign manufacturer, including scheduling facility inspections if needed.

Business Presence

Maintain a place of business with telephone and email connections within the country during the agreement term.

Complaint Handling

Assist with handling complaints.

Regulatory Monitoring

Monitor and alert the manufacturer to any regulatory changes or new regulations applicable to their product.

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:

Indonesia

IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

Malaysia

IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

Vietnam

IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

Thailand

IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

Philippines

IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

Singapore

IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

Cambodia

IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

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?

Our expert guidance through the region’s evolving regulatory landscape ensures your product remains compliant, allowing you to bring your products to market efficiently and effectively.

Local Authorised Representative