Myanmar: Medical Device Regulatory Updates
Myanmar FDA shared the following statistics:
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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