Myanmar medical device regulatory resources

Competent authority

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

Medical Device Section

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

ASEAN Medical Device Directive as regulatory framework

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).

Medical device definition

'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…

AMDD risk classes A through D for general devices and IVDs.

Class A, Class B, Class C, Class D

Market-access route (import recommendation)

A local company applies to DFDA for a medical device import recommendation certificate (တင်သွင်းခွင့် ထောက်ခံချက်) before importing; documentation requirements are published separately per…

Pre-market certificate types

DFDA issues four pre market certificates: Manufacturing Licence and Product Registration Certificate for locally manufactured devices; Import Recommendation Certificate and Import Notificat…

Foreign marketing-approval evidence required

Class B, C and D import recommendation applications must include Evidence of Marketing Approval from abroad, such as an export certificate, free sale certificate, or marketing history.

Applicant role and authorisation

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.

Manufacturing licence application documents

A medical device manufacturing licence application requires: application letter, company profile, product list and specifications, organisation set up, factory location map and layout plan,…

Class A import dossier

Class A (low risk) import recommendation applications require: cover letter; letter of authorization from owner or manufacturer; product description (if necessary); manufacturing licence or…

Class B import dossier

Class B (low medium risk) import recommendation applications require: cover letter; LOA; product description (if necessary); manufacturing licence/GMP/EC certificate; ISO 13485 certificate…

Online booking for submission dates

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.

FDA e-submission system

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…

Complete labeling information

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

ISO 13485 certificate required

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

Manufacturing-site evidence

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/…

Medical electrical evidence

Electrical safety

No source-verified answer is published for this dimension yet.

Imported medical-device certificate · FDA Myanmar import review

30-90 working days

Renewal of import registration certificates

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 l…

No source-verified answer is published for this dimension yet.

Public list of approved import registrations

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, Nam…

Weekly publication of certificate holders

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

Clinical evaluation report (Class C/D)

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.

COVID-19 import-recommendation relaxations

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…

DFDA post-market control activities

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 co…

Mandatory Problem Reporting Form

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.

Field safety corrective action

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

No source-verified answer is published for this dimension yet.

No source-verified answer is published for this dimension yet.