In order to strengthen state management and ensure strictness in the healthcare sector, Decree 90/2026/ND-CP was issued with many important adjustments and additions regarding the sanctioning of administrative violations. Below are the notable new points that healthcare facilities, pharmaceutical, and medical equipment enterprises need to grasp to ensure legal compliance.

Adding regulations on handling violations in the electronic environment

One of the prominent new points of the Decree is the official legalization of regulations on handling administrative violations in the electronic environment (at Clause 13, Article 3). This is implemented synchronously according to current regulations, helping management agencies strictly control healthcare, pharmaceutical, and medical equipment business activities in cyberspace.

Increasing fines for violations in drug registration and manufacturing

The new Decree has increased fines for many violations in the stages of drug registration and manufacturing (Article 56, Article 57). Specifically, a fine of 30 – 50 million VND is applied for acts such as: failing to implement a risk management plan for vaccines; failing to report the revocation of a foreign facility’s license; or having a drug registration certificate revoked. A fine of 50 – 70 million VND is applied for the act of failing to notify the decision to recall outsourced drugs or discovering falsified Good Manufacturing Practice records. Regarding manufacturing, putting drugs using untested raw materials into circulation will be heavily fined from 30 – 40 million VND.

Tightening regulations on the wholesale, export, and import of drugs

For wholesale (Article 58) and export-import (Article 60) activities, the Decree details violations and corresponding fines to ensure the quality of circulating drugs. The act of storing drugs at the wrong location is subject to a fine of 30 – 40 million VND, while trading outside the licensed scope is fined from 40 – 60 million VND. Especially in import activities, the act of importing without a license or with incorrect information will face very high fines, ranging from 70 – 80 million VND.

Strongly increasing sanctions for the medical equipment sector

The medical equipment sector recorded a doubling of fines for many violations (Article 71, Article 73). Failure to classify or announce classification results is fined from 25 – 50 million VND. More seriously, if failing to stop circulation or not recalling medical equipment with a circulation number (when the classification has been revoked, goods have been cleared but not yet sold to users), the facility can be fined from 80 – 100 million VND. Errors regarding the lack of labels or lack of Vietnamese instructions for use are also strictly penalized from 20 – 40 million VND.

Abolishing warnings for violations of health insurance contributions

In the field of Health Insurance (Articles 81, 82), the Decree shows a tougher stance against delayed or evaded health insurance payments. Typically, the abolition of the warning penalty for failing to pay health insurance for mandatory subjects; instead, violators will immediately face a direct fine of 300,000 – 500,000 VND.

Healthcare facilities and enterprises need to urgently review and update these new regulations to perfect their operating procedures and avoid unnecessary legal risks.

Center for Support & Continuing Education – According to the Vietnam Ministry of Health