🇲🇲 Myanmar medical device regulatory data

Statement

Myanmar's Consumer Protection Law 2019 prohibits an entrepreneur from publishing any of six categories of advertisement: fraudulent advertisements about the quality, quantity, ingredients, mode of use, price, rate of service or time needed to deliver the goods or services; fraudulent advertisements about the warranty of goods or services; advertisements containing false information about goods or services; advertisements that are not informative about the risk of using the goods or services; advertisements using any person or event without that person's permission; and advertisements inconsistent with existing laws or ethics. The prohibition is a general one addressed to entrepreneurs in respect of 'goods or services'; a medical device is 'goods' within the Law's definition ('objects that are purchased, used or consumed aiming at a consumer or other persons'). No device-specific advertising instrument, pre-approval requirement or advertising code issued by the Department of Food and Drug Administration was located, so these general prohibitions are the advertising rules that apply to a medical device in Myanmar.

Prohibited Advertisement Categories

quality/quantity/ingredients/mode of use/price/rate of service/delivery time misrepresentation; warranty misrepresentation; false information; failure to inform about the risk of use; use of a person or event without permission; inconsistency with existing laws or ethics

Applies To

goods or services; a medical device is 'goods' under s. 2(d)

Sanction

offence under s. 70 (Chapter XXIV, Offences and Penalties)

Statement

Myanmar's Consumer Protection Law 2019 separately restricts sale promotion. An entrepreneur may not make a sale promotion regarding goods or services by offering to sell the goods at a special price within a period without any plan to sell the advertised amount or quality within that period; by offering to sell goods by pledging to pay a bonus or to provide free services which cannot actually be provided; or by any means that disturbs the consumer physically or mentally. The Law also makes it unlawful to produce, trade or sell goods or services that are not in conformity with the information stated on the label under s. 41, or that are not in conformity with the descriptions in the advertisement and sale promotion — so a promotional claim about a medical device must match the goods actually supplied.

Prohibited Promotions

unplanned special-price offers with no plan to supply the advertised amount or quality; unfulfillable bonus or free-service pledges; promotions that physically or mentally disturb the consumer

Conformity Duty

s. 67(a) and (b): goods must conform to the label information under s. 41 and to the descriptions in the advertisement and sale promotion

Medical device import registration certificates are subject to validity extension (renewal, သက်တမ်းတိုး); DFDA publishes half-yearly lists of renewed certificates (e.g. July-December 2025 list published 2 February 2026).

Department of Food and Drug Administration (DFDA, Myanmar FDA) under the Ministry of Health is the competent authority for medical devices.

A dedicated Medical Device Section within DFDA administers medical device pre-market control (manufacturing licences, product registration, import recommendation/notification certificates) and post-market surveillance.

A clinical evaluation report is required in Class C and Class D import recommendation applications; it is not listed in the Class A or Class B document requirements.

'Medical Device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article intended by the product owner for human use for diagnosis, prevention, monitoring, treatment or alleviation of disease, and related listed purposes, which does not achieve its primary intended action by pharmacological, immunological or metabolic means.

Class A (low risk) import recommendation applications require: cover letter; letter of authorization from owner or manufacturer; product description (if necessary); manufacturing licence or GMP certificate copy; ISO 13485 certificate copy; complete labeling information; copy of local business licence or certificate of incorporation.

Class B (low-medium risk) import recommendation applications require: cover letter; LOA; product description (if necessary); manufacturing licence/GMP/EC certificate; ISO 13485 certificate copy; certificate of analysis or declaration of conformity including compliance standard; declaration of product safety; manufacturing process; evidence of marketing approval; risk analysis and risk management report; complete labeling information; local business licence/incorporation copy.

Class C and D import recommendation applications require 13 items: cover letter; LOA; product description; manufacturing licence or GMP certificate copy/EC certificate; ISO 13485 certificate copy; certificate of analysis/declaration of conformity including compliance standard; risk analysis and risk management report; clinical evaluation report; declaration of product safety; manufacturing process; evidence of marketing approval; complete labeling information; local business licence/incorporation copy.

Both the dossier and product samples must be submitted for medical device import applications; dossier requirements are published on www.fda.gov.mm.

The applicant is a local company (copy of business licence or certificate of incorporation required) acting with a letter of authorization from the product owner or manufacturer.

A medical device manufacturing licence application requires: application letter, company profile, product list and specifications, organisation set-up, factory location map and layout plan, staff education/responsibilities, QC supervisor name and background, staff health certificates, machinery list with photos, manufacturing process with photos, QC procedures and tests, raw-material supplier list and specifications, certificate of analysis for each product, labeling information, copy of company business licence, and copy of the old manufacturing licence for renewal cases.

Complete labeling information must be included in the dossier for import recommendation applications at all classes (A, B, C/D).

DFDA regulates and classifies medical devices according to the ASEAN Medical Device Directive (AMDD), and hosts the AMDD document on its official website (PDF uploaded October 2024).

DFDA Medical Device Section post-market control comprises market sample collection, laboratory testing of market samples, handling of medical device adverse event reporting, field safety corrective action, and awareness programs to consumers and healthcare professionals.

DFDA operates an official e-submission portal ('E-Submission of Food, Drug, Medical Device and Cosmetic System') at esubmission.fda.gov.mm covering medical device submissions, with account registration, login, a product validation check (search-product) and a user manual guide.

Medical device import applications start with an online booking at https://onlineservices.fda.gov.mm to obtain a submission date, selecting an individual or grouping category.

A copy of the ISO 13485 certificate is required in import recommendation applications for all classes (A, B, C/D).

A manufacturing licence or GMP certificate copy is accepted as manufacturing-site evidence (Class A); for Class B, C and D an EC certificate is additionally accepted (manufacturing licence/GMP/EC certificate).

Field safety corrective action, including repair/modification and market recall, is an established DFDA post-market measure for medical devices.

DFDA issues four pre-market certificates: Manufacturing Licence and Product Registration Certificate for locally manufactured devices; Import Recommendation Certificate and Import Notification/Registration Certificate for imported devices.

134 categories of medical devices (e.g. adhesive bandage/tape/plaster for general use, ambu bag, autoclave, audiometers) are exempt from the DFDA import recommendation, per the official exemption list published 20 March 2019.

A local company applies to DFDA for a medical device import recommendation certificate (တင်သွင်းခွင့် ထောက်ခံချက်) before importing; documentation requirements are published separately per AMDD risk class (Class A, Class B, Class C/D lists).

If the device applied for is a Rapid Diagnostic Test Kit, an original recommendation from the National Health Laboratory must be attached to the import recommendation application.

During COVID-19, DFDA relaxed the import recommendation: (a) not requiring recommendation - face shield, non-medical use face mask, PPE, surgical/isolation gown (non-sterile), BP cuff (manual), apron, examination glove; (b) temporarily not requiring - thermometer (digital and non-contact infrared), oxygen concentrator, pulse oximeter, oxygen nasal prong, oxygen face mask, BP cuff (digital); (c) still requiring - infusion and suction pump, nebulizer, ventilator, patient monitor, surgical glove.

Statement

Myanmar's Consumer Protection Law 2019 provides an administrative appeal channel. A person dissatisfied with an administrative order passed by the Office under s. 52 may appeal to the Committee concerned; a person dissatisfied with an administrative order passed by the Committee under s. 53, or with an order passed under s. 56(a), may appeal to the Commission, in each case within 30 days from the date the order was passed. On an appeal the Committee may confirm, amend or cancel the order of the Office, and the Commission may confirm, amend or cancel the order of the Committee or its own earlier decision; the Commission's decision is final and conclusive. This is the only appeal or review channel evidenced for a supplier of goods in Myanmar: no instrument of the Department of Food and Drug Administration providing for reconsideration, review or appeal of a medical-device registration decision could be reached.

First Instance

the Committee concerned (against an Office order under s. 52)

Second Instance

the Myanmar Consumer Protection Commission (against a Committee order under s. 53 or an order under s. 56(a))

Time Limit

30 days from the date of the order appealed against

Finality

the decision of the Commission is final and conclusive

DFDA publishes the list of approved medical device import registrations (e.g. January-June 2026) as a downloadable spreadsheet with columns: No., Company Name, Product Name, Brand Name, Name and Country of Legal Manufacturer, Name and Country of Physical Manufacturer.

The list of companies and medical devices holding import certificates is announced weekly on www.fda.gov.mm.

DFDA publishes a Mandatory Problem Reporting Form (ADR report format PDF) on its official website for download and use in medical device problem/adverse-event reporting.