Foreign Manufacturer Scope and Licence Requirements in Myanmar

1. Key takeaways

The activities that foreign manufacturers may undertake in Myanmar are subject to an explicit scope restriction: they may engage in import, distribution and sale only for 24 categories of products, and they must obtain a wholesale or retail licence under Notification 25/2018 of the Myanmar Ministry of Commerce. Activities beyond that scope require separate confirmation of the legal basis.

• This restriction, stacked on top of the requirement that a foreign manufacturer must submit through a local AR, forms a dual entity threshold for market access in Myanmar: the submitting entity must be a local entity, and that entity must hold the corresponding commercial licence.
• When selecting an AR, companies must verify the business scope and the licence qualifications at the same time, because a representative that is registered but unlicensed, or licensed but outside the device scope, will fail one of the two threshold tests even though it appears qualified on paper.
• The 24 product categories include pharmaceuticals, medical devices and hospital equipment, so the coverage is broad but still bounded.
• The wholesale or retail licence is a Ministry of Commerce permit, not a health authority permit, so the two procedures cannot substitute for each other.
• The enforcement basis for non-compliant activity remains section 3(3)(d) of the Public Health Law 1972, which means that acting outside the licensed scope is not merely a commercial irregularity but an enforceable compliance defect.
• The dual threshold operates cumulatively at different authorities: DICA registration validates the entity, the Ministry of Commerce licence validates the commercial activity, and the FDA validates the product. A gap at any one of the three layers stalls the whole access chain, so the verification of all three should be completed before contract signature with the local partner.

2. Legal basis

The table below sets out the scope and licensing requirements applicable to foreign manufacturers, together with the institutional coordinates that govern the device pathway.

3. Expert insights

Insight 1: the scope restriction and the entity restriction are two different layers and must be satisfied separately. The scope restriction answers what may be done; the entity restriction answers in whose name it may be done. Satisfying only one of the two does not constitute compliance, and a submission that passes the entity test can still be refused at import if the underlying commercial activity falls outside the licensed scope.

Insight 2: the 24 categories include pharmaceuticals, medical devices and hospital equipment, with broad coverage but a clear boundary. Before planning entry into Myanmar, companies should check whether their specific product category falls within the list, rather than assuming that all devices are covered. The composition of the list should be confirmed against the current text of Notification 25/2018, as a practical estimate pending verification.

Insight 3: the wholesale or retail licence is a commerce-side permit, not a health-side permit. This means that companies must run two procedures in parallel: the health authority (FDA registration) and the commerce authority (wholesale or retail licence), and neither can replace the other. In practice the two timelines are also governed by different review rhythms, so a delay in the commerce licence cannot be recovered by accelerating the FDA submission, and the project schedule must reserve independent buffers for both.

Insight 4: the business scope of the AR must match the product category. If the registered business scope of the AR does not cover medical devices, the submission may still fail even if the AR holds a wholesale or retail licence.

Insight 5: compared with ASEAN markets that have completed dedicated legislation, Myanmar restricts foreign entities more directly. This determines that the selection of the local partner is the first decision of Myanmar market access, and its importance is higher than the preparation of documentation itself. A well-documented dossier submitted by a partner without the proper licences cannot move forward, while a properly licensed partner can carry a standard dossier through the system.

4. Practical recommendations

• Verify the company registration and business scope of the AR before signing. Obtain the DICA registration documents and check the wording of the business scope.
• Confirm that the AR already holds the Ministry of Commerce wholesale or retail licence. Request a copy of the licence and check its validity period.
• Check whether the products fall within the 24 categories. Complete this at the project initiation stage to avoid rework midway.
• Agree on cooperation obligations for changes of business scope in the agreement. Prevent submission interruption caused by qualification problems.
• Schedule according to the dual threshold. Plan the commerce licence and the FDA registration on a parallel timeline.

5. Verification checklist

• □ Confirmed that the activities of foreign manufacturers in Myanmar are limited to 24 categories of products
• □ Confirmed that a wholesale or retail licence under Notification 25/2018 of the Ministry of Commerce must be obtained
• □ Verified the DICA company registration and business scope of the AR
• □ Confirmed that the AR holds a valid wholesale or retail licence
• □ Checked whether the products fall within the 24 categories
• □ Agreed cooperation obligations for qualification changes in the agreement
• □ Scheduled the commerce licence and the FDA registration in parallel

Regulatory information verified as of 29 October 2026.

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