Myanmar: Medical Device Regulatory Updates

Myanmar FDA shared the following statistics:

Local Manufacturer

• Manufacturers for low and medium risk device: 6, excluding small and medium enterprises and export-only device factories

Myanmar announced the updates on:

1. Exemption List of Medical Devices

• Previously 126 items, now updated to 130 items

• These products are exempted for import recommendation and import notification

2. Grouping System

• Approval on application of Device grouping system, with effect from May, 2019

• 3 Categories – Family, System and Group (kit)

Online booking is first step for medical device application.

Case submission is according to booking appointment date.

3. Post Market Surveillance

• Mandatory reporting form is circulated through Medical Device Importer Association

• Local manufacturers are regularly assessed for distribution records and complaint handling records

• Specific medical device such as high-risk equipment are in surveillance in cooperation with clinical profession

4. Future Plans

• ​Advocacy workshops for Medical device law

• Develop the Orders and Guideline for Product registration and Manufacturer/Importer Licensing

• Post market surveillance guidelines

• Online registration system

• Medical Device Vigilance system with cooperating partners

Reference: Department of Food and Drug Administration, Ministry of Health and Sports Myanmar

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