On 6 July 2026, the Ministry of Health (MoH) issued an official dispatch seeking comments from agencies and organizations on the project formulation dossier for the Medical Device Supply Chain Management Project 2026–2030, Vision to 2035, attached herewith in Vietnamese.
Although the consultation period has concluded, the draft project provides an important indication of the MoH’s proposed direction for the future management of the medical device supply chain in Vietnam.
The proposed measures indicate a gradual shift toward greater digitalization, traceability, post-market regulatory oversight, and strengthened quality management throughout the medical device lifecycle.
Read the full official dispatch here: PROJECT MEDICAL DEVICE SUPPLY CHAIN MANAGEMENT 2026 – 2030, VISION TO 2035.
Purpose of the Official Dispatch
To seek comments from agencies and organizations on the project formulation dossier based on the Official Dispatch No. 5003BYT-HTTB.
To outline the proposed direction for strengthening medical device supply chain management in Vietnam.
Scope of Application
This proposed roadmap is relevant to manufacturers, importers, distributors, suppliers, healthcare facilities, and other stakeholders involved in the medical device supply chain in Vietnam.
It is particularly relevant to stakeholders involved in registration, distribution, traceability, pricing, quality management, and post-market surveillance of medical devices.
Project Objective
The Project aims to establish a modern, transparent, data-driven, and interoperable medical device supply chain management system, supported by a unified national database and comprehensive digital transformation.
The system is intended to enable end-to-end traceability, ensure the continuous supply of safe and quality medical devices, and strengthen regulatory oversight throughout the product lifecycle.
By 2035, Vietnam aims to achieve Maturity Level 3 (ML3) for supply chain governance and meet certain criteria of Maturity Level 4 (ML4) in accordance with World Health Organization (WHO) standards.
Proposed Roadmap for 2026–2030
The 2026–2030 period focuses on developing the legal, digital, and operational foundations for stronger supply chain management.
Key proposed measures include:
- Develop a harmonized legal framework and inter-agency coordination mechanism for medical device supply chain management.
- Operate the national medical device database system linked with the National Population Database.
- By 2028, 100% of newly issued registration numbers for implantable devices, life-support equipment, diagnostic imaging, and In Vitro Diagnostics (IVD) must incorporate Unique Device Identification (UDI) code.
- By 2030, 100% of Class C and D medical devices, as well as certain Class B medical devices, must incorporate a UDI code upon new registration.
- Implement real-time online price listing.
- Issue and implement Good Distribution Practice (GDP) standards specifically for implantable and life-support device groups.
- By 2030, at least 50% of suppliers of implantable and life-support device categories are expected to comply with GDP requirements.
- Transition from pre-market inspection to post-market surveillance for quality control.
Proposed Roadmap for 2031–2035
The 2031–2035 period focuses on further digitalization, data-driven supply management, and broader traceability across the medical device lifecycle.
Key proposed measures include:
- Apply Artificial Intelligence (AI) and Big Data to forecast demand and regulate market supply.
- Expand comprehensive traceability from market circulation to end-use across most types of medical devices.
- Finalize GDP standards for 100% of Class C and D medical devices.
- Establish real-time safety alert and recall systems.
Key Regulatory Focus Areas
The proposed roadmap indicates increasing focus on:
- Digitalization of medical device supply chain management
- National medical device database development
- Unique Device Identification (UDI) implementation
- Good Distribution Practice (GDP) requirements
- Real-time online price listing
- Post-market surveillance
- Traceability from market circulation to end-use
- Real-time safety alert and recall systems
Implications to Clients
Clients should monitor further developments regarding the Medical Device Supply Chain Management Project and assess the potential impact of the proposed roadmap on their medical device operations in Vietnam.
In particular, clients should consider the potential future implications of the proposed UDI, GDP, traceability, pricing transparency, and post-market surveillance requirements.
Clients should also assess whether any adjustments to their existing regulatory, supply chain, quality, or data management processes may be required.
Implementation Date
The official dispatch was issued on 6 July 2026.
The measures outlined above form part of the proposed 2026–2035 roadmap and should not be considered as immediately applicable mandatory requirements unless and until implemented through the relevant legislation or regulatory instruments.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Vietnam, please contact sales@andamanmed.com.