Establishment licensing · Southeast Asia
MediPass provides pre-incorporation compliance advice and local business licensing support for overseas medical device manufacturers. Plan personnel, premises and quality management arrangements before starting import and distribution activities.
Singapore · Malaysia · Indonesia · Thailand · Vietnam
Consider medical device licensing during company setup to reduce later changes to business scope, premises and responsible personnel.
MediPass can work with your appointed law firm or accounting firm to check planned activities and licensing requirements early, helping reduce document rework and repeated coordination.
Overseas medical device manufacturers planning to manage local markets through their own teams should review foreign ownership, funding, local personnel and medical device operating requirements, and confirm whether the proposed entity may conduct import or sales activities under local rules. The following outlines key setup considerations for medical device import and distribution companies in Singapore, Malaysia, Indonesia, Thailand and Vietnam.
Yes. An overseas manufacturer may establish a wholly owned subsidiary and apply for the relevant HSA medical device importer’s and wholesaler’s licenses for its intended activities. The company must have at least one director who meets Singapore’s local residency requirements and appoint an eligible company secretary.
Alternatively, appoint MediPass as the license holder to directly submit product registration applications and hold the product registration certificates on your behalf. Your company then only needs to issue distributor authorizations to develop and manage its local distributor network.
Singapore Licensing / License HoldingYes. A wholly foreign-owned company must meet the RM 1 million shareholders’ funds requirement where the relevant distributive trade rules apply. Alternatively, a joint venture with genuine Malaysian local ownership of at least 51% may be considered. The applicable funding and operating conditions must be assessed against the planned activities and ownership structure.
Alternatively, appoint MediPass as the license holder to directly submit product registration applications and hold the product registration certificates on your behalf. Your company then only needs to issue distributor authorizations to develop and manage its local distributor network.
Malaysia Licensing / License HoldingYes. An overseas manufacturer may establish a wholly foreign-owned medical device import and distribution company as a PT PMA. The general minimum paid-up capital is IDR 2.5 billion, while wholesale activities also require an investment value exceeding IDR 10 billion. Even where Indonesian shareholders hold a majority stake, a company with direct foreign ownership generally remains classified as a foreign investment company.
Alternatively, appoint MediPass as the license holder to directly submit product registration applications and hold the product registration certificates on your behalf. Your company independently selects, develops and manages its distributor network. MediPass works with your designated local distributors to coordinate compliant imports and follow-up regulatory matters.
Indonesia Licensing / License HoldingYes, but the applicable foreign business licensing or exemption route must first be confirmed. Under the Foreign Business License (FBL) route, minimum capital is at least THB 3 million per business activity, with the actual amount assessed against projected operating expenditure. Paid-up capital of THB 100 million per wholesale outlet is a separate route that may qualify the wholesale business for an FBL exemption. A joint venture with genuine Thai local ownership of at least 51% may also be considered. Medical device activities must still meet Thai FDA requirements.
Alternatively, appoint MediPass as the license holder to directly submit product registration applications and hold the product registration certificates on your behalf. Your company independently selects, develops and manages its distributor network. MediPass works with your designated local distributors to coordinate compliant imports and follow-up regulatory matters.
Thailand Licensing / License HoldingYes. Subject to applicable market access conditions, a wholly foreign-owned company may import and wholesale medical devices without a mandatory Vietnamese shareholder. These activities generally have no uniform statutory minimum charter capital, but funding should remain consistent with the business plan. At least one legal representative must reside in Vietnam, and technical personnel, storage and operating-condition declaration requirements must be assessed according to the device category.
Alternatively, appoint MediPass as the license holder to directly submit product registration applications and hold the product registration certificates on your behalf. Your company then only needs to issue distributor authorizations to develop and manage its local distributor network.
Vietnam Licensing / License HoldingAfter establishing a local company, you must also meet the target country’s medical device import and distribution requirements and obtain the applicable business approvals. The following outlines key requirements and official sources for five countries.
GDPMDS — Good Distribution Practice for Medical Devices
Importers and wholesalers may adopt GDPMDS as their distribution quality management system and apply for HSA importer’s and wholesaler’s licences.
Under the GDPMDS route, companies handling Class B, C or D medical devices must submit a certificate and audit report. Companies handling Class A medical devices only may submit a declaration of conformity under the applicable requirements. Certification must be performed by a certification body accredited by the Singapore Accreditation Council (SAC).
HSA: Quality Management System Requirements for Medical Devices ↗
GDPMD — Good Distribution Practice for Medical Devices
Importers, distributors and authorised representatives (ARs) need GDPMD certification appropriate to their activities and must apply for an MDA establishment licence.
GDPMD auditing and certification are carried out by an MDA-registered conformity assessment body (CAB). Establishments must implement the applicable distribution procedures and submit the resulting certificate as part of their establishment licence application.
CDB (CDAKB) — Good Distribution Practice for Medical Devices
After obtaining a medical device distribution business licence, an establishment must obtain CDB certification before starting distribution activities.
Establishments must meet requirements for a qualified technical person responsible (PJT), storage facilities and distribution management. Certification preparation includes PJT training, quality management documents, implementation records and self-assessment evidence.
Indonesia Ministry of Health Regulation 11/2025: Distribution and CDB Certification ↗Document pages 261 and 443–444.
GDP — Good Distribution Practice for Medical Devices
Medical device importers and sales licence holders must comply with Thai FDA GDP requirements.
Establishments must manage personnel, storage, transport and distribution, and prepare quality management documents and implementation records for the applicable implementation phase. Thai FDA’s inspection and assessment guide can support self-assessment and preparation for regulatory inspections.
Thai FDA: GDP Inspection and Assessment Guide ↗Document reference: GDP-G-1-001.
Trading Eligibility Declaration, Storage and Transport Controls
Trading Class B, C and D medical devices requires compliance with local operating conditions and the applicable declaration, unless an exemption applies.
Establishments must have qualified technical personnel, meet storage and transport conditions, and submit a trading eligibility declaration to the local health authority before starting operations. Exempt devices remain subject to the applicable storage and transport requirements.
Vietnam Ministry of Health: Medical Device Trading Conditions ↗08/VBHN-BYT, Articles 40–42.
Based on target-country requirements and your business progress, MediPass can help prepare premises, arrange technical personnel, develop quality system documents, follow up local submissions and support applicable on-site audits.
Discuss Licensing SupportMediPass provides specialist support for medical device business licensing. Your law firm or accounting firm handles company incorporation and related legal, tax and financial matters. MediPass can review business scope, premises, personnel and import and distribution system requirements early, and work with your advisers to prepare the subsequent licensing application.
Usually not; we can first assess whether your existing company can be adapted. MediPass reviews its business scope, licences, premises and personnel arrangements to identify what can be retained and what needs to be added or adjusted before planning the application.
Yes. Based on the target country and product requirements, MediPass can help prepare premises, arrange technical personnel and organise application documents. Reviewing licensing requirements before signing a lease or finalising personnel arrangements can help reduce later changes.
Product-specific market access requirements still need to be checked. Business approvals and product market access are managed separately. Products must follow the registration, declaration or notification requirements applicable in the target country. MediPass can plan product submissions alongside business licensing to coordinate both workstreams.
Timing depends on the target country and your local company’s readiness. Once premises and personnel are ready, the licensing documents and application can move forward. Contact us to discuss the arrangements applicable to your business.
MediPass provides an itemised quotation based on the application scope, identifying service fees, premises rental, equipment and supplies, official fees and any applicable third-party certification or audit fees; official fees are passed through at cost with no mark-up. Additional costs for premises, warehousing or technical personnel arrangements are explained separately in the proposal. If product registration and licence holding are engaged together, the annual holding fee starts one year after the certificate is issued; see the fee structure.
Tell us your target country, whether your local company is already established and the products you plan to handle. MediPass can help confirm preparations for premises, personnel, quality system documents and licensing applications.
Discuss LicensingYou can also email contact@aseanmedipass.com.
