Advertising and Promotion Compliance for Medical Devices in Myanmar

1. Key takeaways

The promotion and advertising of medical devices in Myanmar is governed by the Consumer Protection Law (Law No. 9 of 2019). Because Myanmar has not yet enacted a dedicated medical device law, the rules on device promotion come from the general provisions on consumer protection, not from device-specific provisions. The definitions of advertisement and sales promotion are likewise taken directly from that law, so the vocabulary of the compliance analysis is the vocabulary of consumer protection rather than of device regulation.

GRZAN insight: the direct consequence of this arrangement is that device promotion is placed within the legal framework for general consumer goods. When designing promotional materials, companies must satisfy both the quality and labelling requirements of device regulation and the general truthfulness requirements of the Consumer Protection Law — the two obligations stack, rather than one applying in place of the other. The compliance perimeter can be remembered as: 1 governing law, 2 core definitions, and 1 prohibition on promoting unregistered products.

• 1 governing law — the Consumer Protection Law (Law No. 9 of 2019), which applies to device promotion and advertising in the absence of a dedicated device law.
• 2 core definitions — advertisement and sales promotion, both defined in that law, must be identified separately in every campaign.
• 1 prohibition — unregistered products must not be advertised or promoted in any form.

2. Legal basis

The table below sets out the legal sources governing promotion and advertising. It records the applicable law and the reason it applies, the two statutory definitions taken directly from it, the status of the dedicated device law, and the enforcement authorisation and technical framework that complete the regulatory picture.

3. Expert insights

Insight 1: device promotion is governed by general consumer law, not by a dedicated device law. This differs from the other ASEAN markets that have completed their device legislation, and companies preparing promotional materials should benchmark them against general consumer protection standards. A campaign that would pass review in a market with device-specific advertising rules may still fall short here, because the applicable standard asks consumer-protection questions rather than device questions.

Insight 2: advertisement and sales promotion are two distinct legal definitions and must be identified separately. A single promotional activity may fall within both at the same time, and companies should assess the compliance requirements for each in turn. The definitions are not interchangeable: one concerns informing consumers about goods or services, the other concerns raising awareness and utilisation, and an activity can satisfy one definition while triggering the other, so each element of a campaign needs its own classification.

Insight 3: unregistered products must not be advertised or promoted. This prohibition, together with the requirements on labels and instructions for use, forms the compliance loop that products must complete before entering the market. Promoting a device ahead of registration is not a marginal infraction of taste; it touches the boundary between a product that may lawfully be offered and one that may not, and it should be treated as a hard stop in every launch plan.

Insight 4: promotional materials must be consistent with the approved instructions for use. Contradictions among the three — label, instructions for use, and advertisement — create compliance risk. The approved documentation defines what the product may claim to do, so any promotional statement that departs from it introduces a claim the authority has not reviewed; keeping the three aligned is what makes every public statement traceable back to an approved source.

Insight 5: the Consumer Protection Law provides the catch-all basis for promotion compliance. Even with the dedicated device law absent, promotional conduct remains subject to clear legal constraints. There is no gap through which unreviewed claims can pass: the general law reaches the same conduct that a device law would regulate, which means the absence of device-specific rules narrows the detail of the requirements but not their existence.

4. Practical recommendations

• Self-check promotional materials item by item against the advertisement definition in the Consumer Protection Law. Distinguish advertisement from sales promotion within each campaign.
• Do not conduct promotion of any form before registration is complete. Observe the prohibition on unregistered products strictly.
• Ensure promotional content is consistent with the approved instructions for use. Establish a comparison mechanism to verify the alignment.
• Bring labels, instructions for use, and advertisements under a unified review. Update the three in step whenever any of them changes.
• Track updates to the implementing rules of the Consumer Protection Law. Rely on the latest official announcements as the governing text.

5. Verification checklist

• □ Confirmed that device promotion is governed by the Consumer Protection Law (Law No. 9 of 2019)
• □ Distinguished the two legal definitions of advertisement and sales promotion
• □ Suspended all promotional activities before registration is complete
• □ Completed the consistency comparison between promotional content and the instructions for use
• □ Brought labels, instructions for use, and advertisements under unified review
• □ Established a tracking mechanism for updates to the Consumer Protection Law
• □ 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