Decree to better supervise and manage medical devices

The National Assembly’s Standing Committee on September 17 agreed with the Government about the need to pass a decree to better supervise and manage medical devices.

However, many members of the committee said the Ministry of Health, which is in charge of compiling the draft decree, was overly ambitious when it said the decree should cover almost all fields relating to medical devices, including production, registry for circulation and trade, clinical trials, advertising and labeling, and medical device management at healthcare units.

Deputy Minister of Health Pham Viet Tien said medical devices are special goods that directly affect the quality and efficiency of healthcare services.

Medical devices are rapidly evolving by the day and must be upgraded to meet the latest technological advancements, Tien said, emphasising that it is important to oversee the life cycle of the devices, including production, testing, circulation, use and maintenance at healthcare centres.

Truong Thi Mai, Chairwoman of NA's Social Affairs Committee, said there are thousands of medical devices in use in Vietnam, but current regulations require only 20 devices to undergo testing on a yearly basis.

She added that medical devices made up to 40 percent of assets at public healthcare units. At non-public healthcare units, the cost of medical devices would be part of the medical price that patients had to pay.

NA Chairman Nguyen Sinh Hung said medical device management is loose, which causes damages, affects medical treatment and threatens people's health. For instance, he said the use of outdated technology devices is an issue.

The draft decree will be revised and placed on the agenda of the NA Standing Committee's next meeting.-VNA