Company Qualification Documents for Myanmar Registration

1. Key takeaways

The Myanmar registration dossier imposes three requirements on the company qualification of the local authorised representative (AR): (1) provide a business licence or company registration certificate; (2) the company registration must be valid (for legal entities, DICA registration applies); and (3) the business scope must match the declared product category. The third item, although not explicitly named in the document list, is the substantive standard reviewers apply when verifying the AR’s entity qualification.

GRZAN note: the role of company qualification documents goes beyond proving that the entity exists — it must prove that the entity is entitled to act. If the AR’s business scope does not cover medical devices, the submission may fail even when every listed document is present. The requirement set can be remembered as 3 company qualification requirements plus 1 purchase and sale licence, four in total, and all four should be verified before the appointment agreement is signed.

• Business licence or company registration certificate of the local authorised representative;
• Valid company registration — DICA registration for legal entities;
• Business scope in the company licence that matches the declared product category;
• Purchase and sale licence for importers and distributors.

A practical way to frame the difference: the documents on the list answer the question of who the representative is, while the scope and licence requirements answer the question of what that representative is legally allowed to do. Reviewers check both questions, and only the first one is visible in the published document list, which is why companies must verify the second one themselves before signing any appointment agreement.

2. Legal basis

The qualification requirements for the AR, the parallel licensing duties of importers and distributors, and the separate obligations of foreign manufacturers are summarised below. Submissions go through the Myanmar FDA e-Submission system’s medical device module, and from 8 June 2026 portal login mandatorily requires two-factor authentication (2FA), which means the qualified entity must also have portal-ready accounts and verified staff before it can file anything.

3. Expert insights

Insight 1: the business licence and DICA registration are two different layers. The business licence proves the entitlement to operate; DICA registration proves that the legal entity validly exists. When verifying an AR’s qualification, both are indispensable — checking only one leaves the other unverified and the qualification claim incomplete.

Insight 2: the match between business scope and product category is a hidden threshold. The document list only asks for a business licence, but in practice reviewers check whether the stated scope covers medical devices. This implicit requirement is a common cause of submissions being returned, precisely because it is invisible on the checklist and only surfaces when a human reads the licence text.

Insight 3: importers and distributors carry a separate purchase and sale licence requirement. This licence runs in parallel with the AR’s company registration, and the licence holder is the party designated by the product principal. Companies mapping their local supply chain should treat it as its own workstream rather than assuming it is covered by the AR file.

Insight 4: the foreign manufacturer’s wholesale / retail licence is an independent step. Under Ministry of Commerce Notification 25/2018, foreign manufacturers must obtain this licence, and it cannot be replaced by the FDA registration certificate — the two instruments serve different authorities and different legal purposes. Planning them as separate workstreams with separate owners avoids the assumption that finishing one has advanced the other.

Insight 5: validity-period management of qualification documents is part of ongoing compliance. Business licence renewals, DICA annual requirements and the various licences all carry deadlines. A single consolidated reminder register across all these expiry nodes prevents a lapsed certificate from silently invalidating an otherwise valid qualification set, and it also gives the AR a documented basis for proving continuity of qualification when reviewers or the product principal ask for it.

4. Practical recommendations

• Verify the AR’s business licence and DICA registration before signing. Request copies and cross-check them against the product manual information.
• Check that the business scope explicitly covers medical devices. Do not accept vague or generic wording.
• Confirm that importers and distributors hold purchase and sale licences. Build this into the local supply chain access checklist.
• Obtain the wholesale / retail licence for the foreign manufacturer. Process it under Ministry of Commerce Notification 25/2018.
• Set up an expiry reminder register for all qualification documents. Cover annual inspections and licence renewals.

Taken together, the four requirements form a single qualification gate: the entity must exist validly, be licensed to operate, hold a scope that covers the declared product category, and — where it moves goods rather than merely represents the principal — carry the corresponding purchase and sale or wholesale / retail licence. Verifying all four before the dossier is drafted is far cheaper than discovering a gap after the application has been filed and returned.

5. Verification checklist

• □ Business licence or company registration certificate of the local authorised representative obtained
• □ Validity of the AR’s DICA registration verified
• □ Business scope confirmed to explicitly cover medical devices
• □ Importers and distributors confirmed to hold purchase and sale licences
• □ Wholesale / retail licence obtained for the foreign manufacturer
• □ Expiry reminder register established for all qualification documents
• □ Qualification maintenance obligations agreed in the contract

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