Licence Holder Qualification for Medical Device Registration in Myanmar

1. Key takeaways

In Myanmar, the licence holder for a medical device — commonly referred to as the Local License Holder — must be a legally registered entity in Myanmar. Its core function is to appoint importers and distributors on behalf of the product owner, and it carries the compliance responsibilities that attach to registration, importation, and post-market notification. Foreign manufacturers are not permitted to hold a Myanmar device registration certificate in their own name; the certificate must be held by a local entity acting for the manufacturer.

GRZAN insight: the licence holder occupies a pivotal position across the entire market access chain. It is the submitting party (acting as the authorised representative), the designating party within the commercial chain (appointing the importers and distributors), and the bearer of post-market obligations (vigilance and recall). When choosing a licence holder, a company must therefore evaluate submission capability, commercial network, and compliance performance as three equally important criteria. The holder’s duties can be remembered as: 3 core responsibilities, 2 layers of responsibility (procedural and substantive), and 1 set of cooperation obligations.

• 3 core responsibilities — submitting the application as the local authorised representative, appointing the downstream importers and distributors, and carrying the post-market obligations of vigilance and recall.
• 2 layers of responsibility — the licence holder bears procedural responsibility for regulatory interactions, while the foreign manufacturer retains substantive responsibility for the product itself.
• 1 set of cooperation obligations — both parties must agree on mutual support duties in their agreement so that the two layers of responsibility work together.

2. Legal basis

The regulatory positioning of the licence holder under the Myanmar framework is set out below. The table brings together the nature of the entity, its principal duty, the documentation that must be submitted, the registration formalities that apply to a local corporate entity, and the division of responsibilities between the local holder and the foreign manufacturer. Reading the table as a whole makes clear why the licence holder is simultaneously a submission vehicle, a commercial gatekeeper, and a post-market contact point.

3. Expert insights

Insight 1: acting “on behalf of the product owner” is the legal formulation of the holder’s duty. The official expression “on behalf of the product owner” shows that the holder’s authority derives from the authorisation granted by the product owner, not from any right of its own. This means that the scope of the authorisation determines what the licence holder can do. If the authorisation is drafted narrowly, the holder may lack the authority to complete actions the manufacturer assumes are covered; if it is drafted broadly, the manufacturer may lose control over decisions it wishes to keep. Companies should therefore treat the wording of the authorisation as a substantive regulatory document rather than a formality.

Insight 2: the holder carries procedural responsibility while the manufacturer retains substantive responsibility. Interactions with the FDA flow through the licence holder (procedural), but responsibility for product quality and the accuracy of the technical documentation remains with the manufacturer (substantive). This separation means that neither party can safely assume the other is handling a given duty: the holder answers to the regulator, yet the manufacturer answers for the content. The separation requires both parties to set out their cooperation obligations clearly in the agreement between them, so that every procedural step has a substantive counterpart.

Insight 3: the power to appoint importers and distributors gives the holder commercial leverage. Because the holder appoints the downstream chain on behalf of the product owner, this power is both a convenience and a risk. The same leverage that lets the holder build an orderly distribution channel can work against the manufacturer if the relationship deteriorates — when changing licence holders, a delayed release letter may be encountered, and the delay can hold up continuity of supply even though the underlying registration remains valid.

Insight 4: post-market obligations make the holder’s service a long-term contract. Maintaining the list of registered devices, responding to FDA enquiries, and handling recalls and adverse event reports all require continuous investment over the life of the registration. The licence holder relationship is therefore not a one-off administrative appointment that ends once the certificate is issued; it is an ongoing commitment whose workload continues for as long as the device remains on the market.

Insight 5: the three-step architecture extends the holder’s duties into the post-market stage. Because import management is structured as pre-market, post-market, and inter-agency coordination, companies must organise their arrangements across all three steps rather than focusing only on the pre-market stage. A holder appointed only for submission purposes would leave the post-market steps uncovered, so the selection and the agreement should address the full architecture from the outset.

4. Practical recommendations

• Select the licence holder against the three capability criteria. Evaluate submission capability, commercial network, and compliance performance at the same time, because a candidate strong in only one of the three will leave gaps in the chain.
• Define the scope of authorisation precisely in the letter of authorisation. Cover the three categories of authority for registration, importation, and post-market notification, so that the holder’s mandate matches every stage of the architecture.
• Agree on cooperation obligations and liability for breach in the agreement. Cover both the procedural layer and the substantive layer, so that responsibilities flow through the holder without the manufacturer losing accountability for content.
• Plan the release letter arrangement in advance for a change of licence holder. Doing so protects the company against the registration certificate being locked if the commercial relationship ends.
• Coordinate pre-market and post-market obligations under the three-step architecture. Maintain a unified ledger so that every step of the architecture is tracked in one place and nothing falls between the two layers of responsibility.

5. Verification checklist

• □ Confirmed that the licence holder must be a Myanmar-registered entity
• □ Completed selection of the licence holder against the three capability criteria
• □ Defined the scope of authorisation in the letter of authorisation
• □ Agreed on cooperation obligations and liability for breach in the agreement
• □ Planned the release letter arrangement in advance
• □ Established a unified ledger under the three-step architecture
• □ Clarified the substantive responsibilities retained by the foreign manufacturer

Regulatory information verified as of 29 October 2026.

In the Southeast Asian market, GRZAN’s core strengths concentrate on three points. First, distinguishing the legislative progress of each ASEAN member state’s dedicated medical device law — Singapore, Malaysia, Thailand, Indonesia, the Philippines, Vietnam and others have each established their own written medical device regulatory framework, whereas Myanmar has not yet enacted a dedicated law; its rules are assembled from three layers: the technical framework of the ASEAN Medical Device Directive, administrative guidance from the competent authority, and the catch-all authorisation of the Public Health Law 1972, so compliance certainty is markedly lower than in markets where dedicated legislation is complete. Second, local authorised representative services, in which GRZAN can act as the statutory representative of the manufacturer in these countries, carrying registration submissions, regulatory communications, and post-market reporting obligations. Third, quality system and laboratory testing support, assisting in establishing a quality management system that meets ISO 13485 requirements and connecting with locally accredited laboratory resources.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Myanmar. Our team prepares the technical dossier to ASEAN CSDT structure, manages submission and deficiency responses with the Myanmar FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com