The Department issued two decisions to cancel a total of 70 self-declared dossiers for category A and B medical devices. The move followed a review of submissions on the national online public service portal for medical device management, which revealed numerous non-compliant filings.

The withdrawals were based on findings that certain products did not meet the definition of medical devices or were not suitable for the risk categories declared.

Several businesses had misrepresented product types, turning non-medical goods into medical devices. Others understated the level of risk to fall under simpler regulatory requirements.

In some cases, applications involved in vitro diagnostic devices, but the stated purposes did not match the relevant classification criteria. Many lacked valid Certificates of Free Sale (CFS), and ISO 13485 certificates were deemed invalid due to being issued by organizations not registered in Vietnam.

Further issues included missing documents on storage and transportation facilities, and errors or omissions in personnel records, labeling, usage instructions, and test results, some originating from unaccredited laboratories.

Amid these findings, the Department urged all entities involved in manufacturing, distributing, or using medical devices to familiarize themselves with applicable regulations and classification procedures.

It also called on them to proactively review their documentation to ensure compliance and to fully cooperate with inspections and post-market surveillance efforts

The Department affirmed its commitment to intensify supervision and will take strict action against any deliberate misreporting for personal or commercial gain.

HCM City increases medical surveillance amid Congo mysterious disease

VOV.VN - The Ho Chi Minh City Department of Health on December 18 directed the City Center for Disease Control (HCDC) to closely monitor the fatal mysterious disease which has emerged in Congo, and to prepare plans to cope with the disease.