Myanmar FDA Releases List of 126 Exempted Devices & Steps up on Post Market Surveillance

December 17, 2018

Myanmar releases updates on the various changes to their regulatory process in the most recent 7th AMDC Meeting.

 

The Myanmar Department of Food and Drug Administration gave news on their harmonization to ASEAN Medical Device Directive:

  • The Myanmar regulatory process is now according to technical guidance from AMDD

  • The Ministry of Health & Sports is undergoing changes to implement AMDD with them already submitting the instrument of ratification to the ASEAN office in July 2018.

  • Their department is also going through processing to develop a new coherent Medical Device Law to comply with AMDD.

 

The state of their National Legislation is as follows:

  • Time frame for the harmonization was 5 years, beginning from 2016.

  • A draft for the Medical Device Law was submitted to the Attorney General Office. 

  • When the Medical Device Law is approved, it will then be submitted to the Myanmar Parliament for additional comments.

 

The current regulation states that there are 3 steps to the importing of a medical device: pre market, post market, and cooperation with related sectors.

 

For Pre Market Control, with the exception of the 126 devices newly exempted,the type of certificates needed for medical devices can go up to 4. Namely, Import recommendation (for importation), Import Notification (for importation), Manufacturing License (for local manufacturers), and Product Registration (For local products).

 

For Post Market Surveillance, the guidelines for market survey and lab testing of market samples are as such. There should be active monthly market sampling every 2 months and a passive surveillance through adverse event (AE) reporting and field safety corrective action (FSCA) of manufacturers and importers. Post Market Surveillance activities are to be strengthened through cooperation with manufacturers and importers/distributors. This is especially true for some high-risk medical devices, which are under surveillance in cooperation with clinical profession.

 

Shown below is the number of post market samples by fiscal year.

The statistics of Certificate for Importation have steadily risen from 2015 to current as can be seen in the graph below.

Myanmar FDA had also expanded their exemption list for medical device. Please refer to the link below for the full list of exempted devices

-Exemption List

 

Contact us at info@arqon.com. 

 

 

 

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