Letter of Authorization Requirements in Myanmar

1. Key takeaways

The Letter of Authorization (LoA) is the legal-standing document in the Myanmar registration dossier, and it must be signed by the foreign manufacturer on its company letterhead. Section 5 of the guideline specifically prescribes its format, which makes the LoA a format-controlled document rather than a piece of free text. Companies that redesign the structure around their own habits routinely create avoidable clarification rounds, because reviewers compare the submitted document against the format the guideline defines, element by element.

GRZAN note: the four mandatory contents of the LoA are (1) it is signed by the overseas manufacturer and set out on company letterhead; (2) it lists the full legal-entity details of the local authorised representative; (3) it defines the device scope (product name, models, manufacturer address); and (4) it states the responsibilities of the authorised representative in registration, import and post-market notification. A missing item affects the legal-standing review. The essentials can be memorised as: the format comes from Section 5 of the guideline, it contains 4 mandatory items, and 1 letter of authorisation is signed.

2. Legal basis

The following points summarise the requirements attached to the LoA in the Myanmar framework. Each row corresponds to an element that reviewers verify during the formal check of the application dossier.

3. Expert insights

Insight 1: the company letterhead requirement in the LoA serves an identity-verification function. The instruction to use company letterhead is not a formality for its own sake: it binds the document directly to the legal identity of the manufacturer, which makes it easier for the Myanmar FDA to verify the authenticity of the signing entity. A letter on plain paper, however carefully worded, does not carry the same evidentiary weight, because it cannot be tied visually and structurally to the corporate entity it claims to represent. When preparing the document, companies should treat the letterhead as part of the substance of the LoA rather than as decoration, and should confirm that the details printed on the letterhead match the manufacturer information given elsewhere in the dossier.

Insight 2: the device scope clause determines the room for later changes. The LoA must list product names and models one by one. Models that are not listed cannot be added through a simple variation; the authorisation must be re-processed or a separate application made. This points to a planning principle: the models a company intends to commercialise in Myanmar should be covered in a single pass at the time of the initial authorisation, because extending the scope later costs a new authorisation cycle rather than a routine amendment. Companies that keep the scope deliberately narrow to save effort at signing often pay for that saving when their commercial roadmap expands, so the drafting session should always involve the product plan, not only the current catalogue.

Insight 3: the responsibility clause is the contractual basis for post-market obligations. The LoA must state the responsibilities of the authorised representative in post-market notification. This arrangement anchors the vigilance reporting obligation at the contract level, so it does not fall away when the cooperation arrangement between the parties changes. In other words, the duty to notify is not an informal expectation between two companies; it is written into the very document the regulator holds on file. A precisely drafted clause also removes ambiguity about who handles safety notifications, which matters most at the moment an incident occurs and every day of delay carries regulatory and commercial consequences. Companies should review this clause with the same care they apply to commercial contracts.

Insight 4: notarisation or legalisation is a conditional requirement. The official wording is that the document must be notarised or legalised when the FDA requires it. The word conditional should not be read as optional: because the condition depends on the judgement of the authority rather than on the preference of the applicant, companies are well advised to prepare for the notarisation scenario in advance. Notarisation that is arranged only after a deficiency letter arrives typically adds weeks to the project, since the document may have to travel back to the country of the manufacturer and pass through the relevant formalities there. Building the notarised version from the start turns a conditional requirement into a settled item.

Insight 5: the LoA, the FSC and the company registration documents form a cross-verification chain. The three documents must match exactly on product names, models and manufacturer information. Any mismatch triggers a request for clarification and can delay the project by months. The most common sources of mismatch are small and preventable: legal suffixes abbreviated in one document and spelled out in another, addresses formatted differently, or product names rendered inconsistently between the certificates and the authorisation letter. A field-by-field comparison carried out before submission costs far less than a clarification round after it. Reviewers use these cross-checks as their primary test of the credibility of an application, so consistency here protects the whole dossier.

4. Practical recommendations

• Use the format text prescribed in Section 5 of the guideline. Do not design an in-house template for the letter of authorisation.
• Cover all planned models in the initial authorisation. This reduces the cost of adding authorisations later in the project.
• State the post-market notification responsibilities of the authorised representative explicitly. Write the vigilance obligations into the contractual terms of the letter.
• Complete the preparation for notarisation or legalisation in advance. Process it ahead of any possible FDA requirement rather than in response to one.
• Build a comparison checklist between the LoA and the FSC. Compare the two documents field by field before submission.

5. Verification checklist

• □ The LoA format prescribed in Section 5 of the guideline has been used
• □ The letter has been signed by the foreign manufacturer on company letterhead
• □ The full legal-entity details of the local authorised representative have been listed
• □ The device scope (product name, models, manufacturer address) has been defined
• □ The responsibilities of the authorised representative in registration, import and post-market notification have been agreed
• □ Notarisation or legalisation has been completed as the FDA requires
• □ The consistency comparison between the LoA and the FSC has been completed

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