Authorized Representative Requirement in Myanmar

1. Key takeaways

Myanmar imposes a non-bypassable entity threshold on medical device registration: a foreign manufacturer may not submit an application directly to the Myanmar FDA without a local entity. The application must be filed in the name of a Myanmar local authorised representative (Authorized Representative, AR), who is typically a registered importer, distributor or specialised regulatory agent in Myanmar. The AR is the legal face of the application in Myanmar, and all FDA correspondence flows through the AR.

• This means that the authorised representative in Myanmar is not a submission agent but the legal applicant. The focus of selection criteria should therefore shift from whether the party can submit to whether it can perform its duties continuously.
• The entity threshold can be summarised as: 1 local entity, 1 authorised letter, and 2 types of identity documents (NRC or passport).
• Corporate entities are required to hold registration with DICA (the Directorate of Investment and Company Administration).
• Submissions are made through the medical device module of esubmission.fda.gov.mm under the AR’s account.
• The foreign manufacturer remains responsible for product quality, the accuracy of the technical documentation and supply chain compliance, while all FDA correspondence flows through the AR.
• Because the AR holds the account and signs as legal applicant, the continuity of the AR relationship directly affects the continuity of the registration, so the stability of the appointment should be assessed at selection rather than assumed.

2. Legal basis

The table below sets out the entity and authorisation requirements as they operate in the FDA submission system. Because the AR carries the procedural status of the application, each row affects the validity of the registration chain.

3. Expert insights

Insight 1: the AR is a legal face, not a mailing address. The official formulation describes the AR as the legal face of the application in Myanmar. The legal meaning is that the counterparty recognised by the FDA is the AR, not the foreign manufacturer. The substantive rights of the manufacturer are not transferred by the existence of the AR, but the procedural status is carried by the AR.

Insight 2: the responsibilities of the AR and the manufacturer are separated, but the consequences are linked. The manufacturer is responsible for quality and technical documentation, while the AR bears the submission, communication and reporting duties. If either party fails, the commercial consequences are borne jointly by both. This signals that cooperation obligations must be agreed in both directions in the agreement.

Insight 3: the account identity document requirements bind the person to the company. Myanmar citizens submit the NRC, foreign applicants submit a passport, and corporate entities additionally require DICA registration. This design makes the entity qualification of the AR verifiable, and it also means that any change of AR requires the identity verification to be completed again.

Insight 4: the AR also designates importers and distributors. The local licence holder designates importers and distributors on behalf of the product owner. This arrangement places the AR at a hub position in the commercial chain, and the manufacturer must bind this hub through contract.

Insight 5: the AR must continue to perform throughout the post-market phase. Its duties include maintaining the device list, responding to enquiries and handling recalls and adverse event reports. This determines that AR services are a long-term contract, not a one-off submission service.

4. Practical recommendations

• Select the authorised representative against a standard of continuous performance. Examine the validity of its company registration, its dedicated staffing and its vigilance system capability.
• Agree on cooperation obligations in both directions in the agreement. Define the manufacturer’s duty to supply documents and the AR’s duty to report and communicate.
• Configure at least two authorised persons for the AR account. Avoid a single point of failure while the FDA issues deficiency requests.
• Establish an annual review reminder mechanism for AR entity qualifications. Cover DICA annual reviews, NRC renewals and passport validity.
• Complete the letter of release arrangement before changing the AR. Prevent the registration certificate from being locked due to a change of entity.

5. Verification checklist

• □ Confirmed that a foreign manufacturer may not submit on its own
• □ Appointed a Myanmar local authorised representative with DICA registration
• □ Signed the authorised letter in the format of Section 5 of the guideline
• □ Configured at least two authorised persons for the AR account
• □ Established an expiry reminder mechanism for AR entity qualifications
• □ Agreed two-way cooperation obligations in the authorised representative agreement
• □ Pre-arranged the letter of release for a future AR change in the agreement

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