Tiếng Việt
Effective from May 15, 2026, Decree 90/2026/ND-CP introduces several important amendments aimed at strengthening regulatory enforcement and compliance management within Vietnam’s healthcare sector.
🔎 Key highlights organizations and healthcare businesses should pay attention to:
✅ Expanded sanctions for violations in digital environments
The Decree introduces clearer administrative penalties for violations conducted through digital platforms, electronic systems, and online healthcare activities.
✅ Increased penalties in the pharmaceutical sector
Additional violations related to pharmaceutical manufacturing, importation, quality control, storage, and distribution are now subject to stricter sanctions and higher fines.
✅ Stricter management of medical devices
The Decree strengthens penalties for violations involving classification, circulation registration, product recall, and quality assurance of medical devices, with fines reaching up to VND 100 million in certain cases.
For medical devices, the new framework reflects a significant increase in regulatory enforcement across the entire product lifecycle, including:
- Medical device classification
- Manufacturing activities
- Registration and market authorization
- Trading, distribution, and importation
- Labeling and Vietnamese Instructions for Use (IFU)
- Post-market surveillance (PMS)
- Management and use at healthcare facilities
The Decree introduces a broader and stricter penalty framework, with administrative fines ranging from VND 500,000 to VND 100 million depending on the severity of violations.
In addition to monetary penalties, supplementary sanctions may include:
⚠️ Suspension of licenses or practicing certificates for 01–24 months
⚠️ Suspension of business operations for 01–24 months
⚠️ Confiscation of non-compliant products and related materials
Notably, regulatory authorities are expected to strengthen enforcement in several critical areas:
– Classification accuracy
– Registration compliance
– Labeling and Vietnamese IFU requirements
– Technical documentation consistency
– Quality management systems
– Post-market surveillance (PMS)
The new regulations represent an important step toward improving regulatory oversight and legal compliance in the healthcare industry. Businesses and healthcare organizations are encouraged to proactively review their operational procedures, legal documentation, and compliance systems to minimize legal risks and ensure sustainable operations.
📌 As Vietnam’s regulatory landscape continues to evolve, companies should proactively review their compliance systems, validate product dossiers, strengthen PMS procedures, and standardize technical documentation to minimize regulatory risks and maintain uninterrupted market access.
👉 View more detail at: NGHỊ ĐỊNH 90/2026/NĐ-CP VỀ XỬ PHẠT VI PHẠM HÀNH CHÍNH TRONG LĨNH VỰC Y TẾ