Local Authorised Representative
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.
At Andaman Medical, we act on your behalf to manage end-to-end regulatory responsibilities. From product registration and import licensing to change notifications, post-market surveillance, adverse event reporting, and product recalls, we ensure smooth market access and sustained compliance.
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?
- 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
What Our Local Authorised Representative Can Do For You
Regulatory Representation
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
Compliance Assurance
Ensure the appropriate conformity assessment procedure is carried out if required.
Labelling and Information
Labelling and Information
Ensure the medical device or IVD is correctly labelled and information is provided in the specified national language(s).
Authority Liaison
Authority Liaison
Accept all communications from local medical device authorities and coordinate with the foreign manufacturer, including scheduling facility inspections if needed.
Business Presence
Business Presence
Maintain a place of business with telephone and email connections within the country during the agreement term.
Complaint Handling
Complaint Handling
Assist with handling complaints.
Regulatory Monitoring
Regulatory Monitoring
Monitor and alert the manufacturer to any regulatory changes or new regulations applicable to their product.
Local Authorised Representative Southeast Asia
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
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
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
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
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
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
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
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
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?
