Malaysia
Assess MDA classification, registration, a local authorised representative and applicable CAB conformity assessment or verification.
ASEAN · Market access
ASEAN medical device registration
A shared product dossier can support a regional plan, but national applications and local responsibilities remain separate. SUNGO coordinates six priority markets.
How SUNGO supports your project
Singapore
Separate HSA product registration from dealer licensing. Class A registration exemption does not remove all import, manufacturing or wholesale obligations.
Thailand
Assess the national route, applicant and documentation using device risk, intended purpose and available evidence.
Vietnam
Plan classification, a local responsible entity and applicable product documentation, with labelling and import arrangements.
Indonesia
Coordinate a local registration holder and application, reviewing manufacturer authorisation, product documentation and local labelling.
Philippines
Assess product and local-establishment requirements and coordinate technical documentation, authorisations and maintenance.
The Common Submission Dossier Template (CSDT) helps organise shared evidence, but there is no single registration certificate covering every ASEAN member. Classification, language, local licensing and post-market obligations remain country-specific.
AFTER THE INITIAL DISCUSSION
Build a product-specific document plan
You do not need every document for the first enquiry. We identify gaps after understanding your product and target market.
Target countries and launch priorities
Instructions, model range and classification rationale
Existing certificates, testing and quality-system documentation
Local partners and their proposed responsibilities
Specific requirements are subject to product assessment and the competent authority’s current regulations.
HSA · Device registration overview ↗ · HSA · Medical devices and dealer licensing ↗ · MDA · Guidance documents ↗
INITIAL CONSULTATION
Start with two things
Send your product name and instructions for use, and tell Serena which market you are considering.
- Product name
- Instructions for use