Medical Device & Cosmetic Registration and Regulatory Services in Southeast Asia
Registration and notification for medical device (GMD), in vitro diagnostic (IVD) and cosmetic companies entering Singapore, Malaysia, Thailand, Vietnam and Indonesia. We arrange the dossier, the local licence holder or responsible party, and ongoing post-market compliance, by product type and target market.
Medical device licences held by our own companies in five markets, no sub-agents · Licence holding separated from sales, you choose the distributor · Feasibility confirmed before we quote
Start with your product type, then see what each market requires.
Medical devices (GMD) and in vitro diagnostics (IVD)
Classification, registration route, dossier and local licence holding. The five markets use similar classification rules but different procedures; we work from the intended use market by market, and our own local companies hold the registrations and the post-market responsibilities.
- General medical devices
- IVD reagents & instruments
- Self-testing IVDs
- Software as a medical device (SaMD)
Cosmetics
Local notification, import support and post-market maintenance in five markets. You develop the brand and the sales channels; MediPass puts the notifier, the import arrangement and the product file in place under each country's rules.
Cosmetic notification overview →Registration, import and post-market responsibilities for medical devices sit with a MediPass company in each market.
| Market | Local entity | Roles | Licences & certifications | |
|---|---|---|---|---|
| Singapore | MediPass Pte. Ltd. | Registrant · Importer · Wholesaler | HSA importer's licence MDIL260115W05 · wholesaler's licence MDWL260115L06 · SS620 GDPMDS certification GDPMDS-SG-082 | Singapore → |
| Malaysia | Medipass Sdn. Bhd. | Authorised Representative (AR) · Importer · Distributor | MDA establishment licences MDA-10150-W126 · MDA-10171-P126 · MDA-10149-D126 · GDPMD certification 4260477 | Malaysia → |
| Thailand | MediPass Healthcare Solutions (Thailand) Co., Ltd. | Importer · Licence holder | Thai FDA medical device importer establishment registration สน. 175/2569 | Thailand → |
| Vietnam | Công ty TNHH Medipass Việt Nam | Registration holder · Trading enterprise | Class B/C/D medical device trading declaration 260000166/PCBMB-HCM | Vietnam → |
| Indonesia | PT Medipass Indonesia Sejahtera | Licensed distributor (IDAK) | CDAKB certificate PB UMKU 080426009746700010038 | Indonesia → |
Validity is as recorded by the issuing authority; certificate extracts are on the credentials page. For cosmetics, the notifier and responsible party are arranged separately for each market; see the cosmetics services page.
MediPass holds the licence. You control the sales channels.
The registration does not have to sit with a distributor. With a MediPass local company as licence holder, you can choose, change and add distribution partners as the market develops.
- You build your own distribution networkChoosing or changing a distributor does not need the licence holder's consent; MediPass works with the distributors you appoint on import and supply.
- MediPass carries the agreed local responsibilitiesLicence holding, registration maintenance, regulator liaison and post-market duties are performed by the local company; document custody, termination and handover are written into the service agreement.
- Changing a distributor normally does not mean a transferWhere the licence holder stays the same, a change of distributor generally needs no re-registration; the new distributor still needs the import or operating licence required locally, and markets where the distributor holds the licence, such as Indonesia, are assessed separately.
- If the current holder will not cooperate, there is a routeWe assess a transfer or a fresh filing by the MediPass local company, and set out what each party has to provide.
Where are you now?
Entering Southeast Asia for the first time
Not sure which class your product falls into in each market, what to prepare, or which country to start with. We confirm feasibility first, then give a market-by-market route and quotation.
Registered in one market, expanding to others
You already have a registration and a technical file and want to reuse it and shorten the timeline. We check each market's requirements for overseas approvals and abridged routes so nothing is prepared twice.
Changing the licence holder or distributor
The certificate sits with a former agent who will not cooperate, or a distributor holds it but is not selling. We assess transfer and re-registration, and our local company takes it on.
You send the intended use, existing approvals and target markets
We confirm whether the product can be filed in each market, the likely class and the route.
Quotation by market and product scope
Registration service fee, annual holding fee and government fees listed separately; government fees at cost, holding fee from one year after issue. Fee structure →
Document review once the project starts
We list the gaps, prepare and submit the dossier, and handle the regulator's queries.
Changes, renewals and post-market matters as agreed
The local licence-holding company carries the ongoing regulatory duties.
Latest regulatory insights
Send us your product details
Tell us the product name, intended use, target markets and any existing registrations. We confirm whether each market is feasible, then set out the registration route and an itemised quotation.