Local Authorised Representative
Local Authorised Representative Southeast Asia
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.
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?
