Importer and Distributor Appointment and the Letter of Release in Myanmar

1. Key takeaways

In Myanmar, the commercial supply chain operates through the Local License Holder appointing importers and distributors on behalf of the product owner. The practical implication of this arrangement is that changing a distributor requires the cooperation of the licence holder, and the key document for securing that cooperation is the Letter of Release. Until the Letter of Release is obtained, the existing registration cannot move to a new distributor, which is why the document sits at the centre of any change of commercial partner.

GRZAN insight: because the Letter of Release must be signed by the original distributor and notarised, obtaining it depends entirely on the willingness of the original distributor to cooperate. For this reason, manufacturers should, at the very moment of signing the distribution agreement, agree in advance on the obligation to issue the Letter of Release, the time limit for issuing it, and the consequences of breach. Building these terms into the first contract is the only effective way to prevent the registration certificate from being locked.

• Who appoints — the licence holder appoints the importers and distributors on behalf of the product owner, so the commercial chain is designated through the holder rather than directly by the manufacturer.
• Key document — the Letter of Release, fully signed and notarised, submitted to the Myanmar FDA, is the instrument that unlocks a change of distributor.
• Timing and remedy — as a practical estimate, distributors are expected to provide the Letter of Release within 14 calendar days of a written request, with liquidated damages of USD 5,000 per week of delay as a contractual convention.

2. Legal basis

The table below consolidates the regulatory and contractual elements of the importer and distributor appointment mechanism. It distinguishes the party holding the power of appointment, the document required for a change of distributor, the signing and notarisation requirements, the authority to which the document is submitted, the way the obligation is triggered, and the associated licensing duties of importers and distributors.

3. Expert insights

Insight 1: the power of appointment rests with the licence holder, not the manufacturer. This means the manufacturer does not directly control the downstream chain. The manufacturer can only shape who distributes its products through contractual arrangements with the licence holder governing how the holder exercises its appointing power. Companies that treat the holder relationship as purely administrative often discover this only when they attempt a change of distributor and find that the decision formally belongs to someone else.

Insight 2: the Letter of Release is the key document for changing a distributor. Without the Letter of Release, the existing registration certificate cannot be transferred to the name of a new distributor, creating registration lock. The consequence is not merely administrative inconvenience: a manufacturer whose certificate is locked may be unable to onboard the commercial partner it has already chosen, and its market presence can stall until the deadlock is resolved.

Insight 3: the 14 days and the USD 5,000 are contractual conventions, not statutory standards. These two figures come from common clauses in distribution agreements and are not a regulatory requirement of the Myanmar FDA. Companies should expressly agree them in their own contracts rather than rely on industry practice. Treating the figures as automatic entitlements, without writing them into the agreement, leaves the manufacturer with no enforceable remedy when a distributor simply declines to cooperate.

Insight 4: the notarisation requirement gives obtaining the Letter of Release a procedural cost. Beyond the distributor’s willingness, the notarisation process itself takes time, which must be counted into the changeover timeline. A schedule that assumes the letter can be produced and filed immediately will underestimate how long the transfer takes, and companies should build the notarisation step into their project planning from the start.

Insight 5: agreeing in advance is better than negotiating afterwards. Agreeing the Letter of Release obligation at the time of the first signing carries far lower negotiation cost than bargaining for it when a change of distributor is already underway. At the initial signing the parties are aligned and concessions are cheap; during a changeover the interests have diverged and the original distributor holds the leverage, which is precisely when the terms are hardest to obtain.

4. Practical recommendations

• Agree on the obligation to issue the Letter of Release in the distribution agreement. State the trigger conditions and the time limit clearly, so the obligation is enforceable without further negotiation.
• Agree on liquidated damages for delayed issuance. Keep the channel for legal remedies open alongside the agreed damages, so that persistent refusal remains actionable.
• Clarify the licence holder’s obligation to cooperate in appointing importers and distributors. This prevents the appointment step from being obstructed when the commercial chain needs to be adjusted.
• Count the notarisation time into the changeover schedule. Do not plan on the assumption that the Letter of Release can be obtained and filed immediately.
• Agree in the contract on the ownership and transfer rules for the registration certificate. Addressing these rules at the source reduces the risk of registration lock later in the relationship.

5. Verification checklist

• □ Agreed on the obligation to issue the Letter of Release in the distribution agreement
• □ Agreed on a liquidated damages clause for delayed issuance
• □ Clarified the licence holder’s obligation to cooperate in appointing importers and distributors
• □ Counted the notarisation process time into the changeover schedule
• □ Agreed on the ownership and transfer rules for the registration certificate
• □ Clarified the requirement that the Letter of Release be notarised
• □ Incorporated the registration ledger into management

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