Medical Device Registration Process In Myanmar
Medical device registration is a mandatory requirement in Myanmar for companies seeking to market and distribute medical devices. The process involves submitting detailed documentation, including technical specifications, safety data, and evidence of compliance with local regulations.
Myanmar offers tremendous business opportunities for U.S. exports of medical devices, equipment, and supplies. Myanmar’s private health sector depends on imported medical equipment and supplies to meet the increasing local demand for high-quality health services.
In Myanmar, there are no specific laws governing medical & IVD devices and laboratory diagnostic testing. Such matters generally come under the cosmetics and medical device section of the FDA, through powers under the Public Health Law 1972.
In order to import medical devices and cosmetics, you need an FDA recommendation.
Regulatory changes
- Burma’s Food and Drug Administration (FDA) announced new food import/export regulations to improve consumer safety and satisfaction.
- In 2019, the FDA implemented an online system for cosmetics and drug import registration, saving time and reducing the risks of favoritism.
Challenges in Myanmar
Along with opportunities, there are significant challenges in the Myanmar healthcare industry. These include
- Poor public health insurance coverage
- Weak enforcement of rules and regulations particularly related to the healthcare sector, and
- a Shortage of healthcare providers.
Regulatory authority for registering medical devices in Myanmar
The regulatory authority for medical devices in Myanmar is the Myanmar Food & Drug Administration.
Myanmar follows the Association of Southeast Asian Nations (ASEAN) Medical Device Directive (AMDD) classification of medical devices follows
Click here to get more details about the (ASEAN) Medical Device Directive (AMDD).
What is interesting in Myanmar is Health care IT, e-health, and mobile medical applications are not specifically regulated, and there is no specific regulation for product marking requirements of medical devices.
Foreign manufacturers
Currently, foreign manufacturers can only import, distribute and sell 24 categories of products in Myanmar. These include medicinal products, medical devices, and hospital equipment. However, they shall obtain the wholesale/retail license (Ministry of Commerce Notification 25/2018).
Classification of the medical device in Myanmar
Medical devices in Myanmar are classified as Class A, B, C, and D in accordance with risk classification rules. (Risk Classification Rules for Medical Devices other than IVD Devices) and (Risk Classification Rules for IVD Devices):
| Class | Risk Level |
|---|---|
| A | Low Risk |
| B | Low-moderate Risk |
| C | Moderate-high Risk |
| D | High Risk |
Registration process
- Based on the risk associated with the medical device, you need to first classify the medical device class before initiating any process of registration.
- If you are a local representative in Myanmar, you need to appoint an Authorized Representative.
- Prepare the technical documentation as per the requirements of the Myanmar FDA and submit it to FDA.
- Once approved by the Myanmar FDA, the medical device can be marketed in Myanmar.
Learn about nutraceuticals, generic drugs, and pharmaceutical products regulatory in Myanmar
Documents required for medical device registration
The required documents for medical devices vary based on the class of medical device. However, in general, these are the following documents that the Myanmar FDA seeks for
- Letter of authorization from a foreign manufacturer
- The free sale or export certificate from the country of origin
- Manufacturing license or GMP certificate
- ISO certificate
- Manufacturing flow chart
- Certificate of analysis for product sample
- Business license/certificate of incorporation of local representative
- Technical Documents
Applicable QMS
ISO 13485 is the applicable Quality Management Sytems for medical devices. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Authorized Representative
For registration of medical devices in Myanmar, you need a local representative who will be a legal representative for all regulatory works
License Validity
The validity of the medical device will be of 5 years.
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