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:
Letter of authorization from foreign manufacturer;
Free sale or export certificate from country of origin;
Manufacturing license or GMP certificate;
Manufacturing flow chart;
Sterilization method, where applicable (i.e. for sterile products);
Certificate of analysis for product sample;
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.
Example Of Approval
ASEAN / Asia REP
Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance.
Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative.
ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally.
Whether you are a local or foreign manufacturer, ARQon can assist to:
Be your local representative in the country.
Submit product registrations for all product classifications.
Set up the QMS & technical file for ISO13485, GDP and CE
Hold product license in the country.
Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
Appoint multiple importers and distributors.
ကြှနျုပျတို့ကိုဆကျသှယျရနျ။ ကူညီရန် ကျွန်ုပ်တို့ ဤနေရာတွင် ရှိနေပါသည်။ ATTOPOLIS ပလပ်ဖောင်းတွင် ကျွန်ုပ်တို့ကို ဆက်သွယ်ပါ။