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Medical Device Product Registration and Approval in Myanmar

MEDICAL DEVICE REGULATION IN MYANMAR

Myanmar has not enacted a Medical Device Act, which is required to be in accordance with the ASEAN Medical Device Directive (AMDD). Nonetheless, medical devices are currently regulated by the FDA of Myanmar, which falls under the purview of the Ministry of Health and Sports. The FDA began accepting applications for registration of medical devices since 2000, by issuing import notifications and import recommendations. Today, the FDA applies the AMDD standards when examining applications. Applications for registration of medical devices have to be filed at the FDA in the name of a local representative, usually the authorized distributor of a foreign manufacturer.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN IN MYANMAR

Generally, medical devices to be imported into Myanmar must be registered with the FDA, by obtaining an import recommendation / notification. The application dossier should include the following documents, although the FDA may stipulate additional documents and information which it may require, depending on the product:

1. Letter of authorization from foreign manufacturer;

2. Free sale or export certificate from country of origin;

3. Manufacturing license or GMP certificate;

4. ISO certificate;

5. Manufacturing flow chart;

6. Sterilization method, where applicable (i.e. for sterile products);

7. Certificate of analysis for product sample;

8. Business license / certificate of incorporation of local representative.

The FDA is in the practice of requiring pre-submission consultations to be held, before applications for import recommendations / notifications are made. This allows the FDA to scrutinize the product and to request additional documents / information that should be furnished at the time of application.

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Resources:

Regulations:

http://www.fdamyanmar.gov.mm/?cat=17