Posted in Legislative Research on May 25, 2020

This bill was posted on the Pyidaungsu Hluttaw website on 18.05.2020 and described in the state-run newspapers Myanmar Alin and The Mirror on 16th, 17th and 18th of May, requesting input from the public.

Current Status (25.05.2020) – awaiting submission to Hluttaw for debate

(1) Backgrounder

On 24th of December 2019, a Food, Drugs, Medical Devices and Cosmetics Laboratory Bill was posted on the website of Pyidaungsu Hluttaw. Drafting was led by the Food and Drug Administration (FDA). This current bill is similar in nature and the two bills are linked, and should be reviewed together.

(2) Bill Summary

The bill includes provisions relating to the classification of medical devices, including conformity assessment, registration, application for licenses and recommendations, as well as labeling, advertisement, market monitoring and reporting of adverse effects, and clinical investigation.

  • Its objectives are:
    • to ensure high-quality medical devices for the public
    • to supervise production, import/export, storage and distribution of medical devices
    • to ensure conformity of assessments among regional countries
    • to reduce trade-related technical barriers in free trade regions.
  • The Union Government will form a Myanmar Authority of Medical Devices not exceeding 15 members. The Minister for Health and Sports will be the chairperson and the Director General of FDA the secretary, with external experts. Its duties are to set policies relating to medical devices and application for licenses and registration, to form committees for technical matters, and when necessary, to establish central, region/state, district and township committees for supervising medical devices.
  • The duty and power of the MoHS are to implement policies set by the Authority and assign and supervise the Department in order to ensure the safety of medical devices.
  • The Department will classify medical devices and their supplementary devices. The classifications must be in line with those of the regional countries.
  • The bill determines the Department’s duties relating to the essential principles of safety and performance, and conformity assessment. Relating to the latter, the Department can accept the certificate of the relevant international quality examination group.
  • It also determines which medical devices need a registration certificate from the Department. If a device that is modified for patients’ needs is in line with the prescribed regulations, registration is not needed. For medical devices not registered but intended for use during a natural disaster or emergent public healthcare, or for teaching/research, the Department can permit the temporary use with the consent of the MoHS.
  • Those who want to produce locally, import/export, store or distribute medical devices have to apply for a license from the Department. Those who want to import/export registered devices have to get the recommendation of the Department to get permission from the relevant government department that issues import/export licenses.
  • Provisions relating to labeling, advertising and clinical investigation are also included.
  • The Department must devise a plan to monitor the safety and performance of medical devices in the market, and can seize devices and restrict the production, sale, use and service from the market if there is any suspicion they may harm the patient and user. For such actions, help can be requested from the police.
  • If the original owner, authorised representative, producer and distributor find about risks associated with a medical device, or a failure of a device to performance as intended by the producer and/or serious adverse effects, they have to report this to the Department. If the user or any person faces serious adverse effects relating to medical devices, they have to report to the Department.
  • The Department must publicly announce medical devices that are not suitable for use, with the consent of the MoHS.
  • Moreover, the bill prescribes administrative penalties, appeals processes, offences and penalties.

Relevant Laws

Myanmar Public Health Law (1972)

Consumer Protection Law (2019)

Link

Bill Text

Contact

Moe Aung, The Ananda, moeaung@theananda.org