Myanmar: Medical Device Regulatory Updates

August 29, 2019

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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