Vietnam Eyes More Oversight of Device Management

September 25, 2015

Members of Vietnam’s National Assembly Standing Committee are urging caution as the government considers a draft decree to beef up management of medical devices.

During a Sept. 17 meeting, several members of the standing committee agreed that stricter controls are needed to ensure the safe use of devices, but said the decree, as worded, would broaden the scope of regulatory control to a degree that could prove difficult to implement. To avoid unduly burdening regulators and industry and ensure the law’s viability, the government should develop an implementation roadmap, they said.

Of the thousands of medical devices available in Vietnam, less than two dozen types are tested annually.

The draft decree covers a range of topics over the lifecycle of medical equipment, including device classification, clinical trials, procurement, advertising, labeling and maintenance within healthcare facilities. Wang Chu Luu, deputy chairman of Parliament, asked health ministry officials to review the decree to ensure it doesn’t duplicate provisions already provided for in existing laws. — Elizabeth Hollis