How Medical Packaging Can Help Medical Device Manufacturers in Vietnam Win Tenders
Vietnam’s regulatory system operates through multiple layers. While the National Assembly passes broad laws, these typically outline general principles rather than detailed requirements. The government then issues decrees to further define how these laws should be implemented, and relevant ministries, such as the Ministry of Health, issue “Circulars” to provide detailed technical guidance, documentation requirements, and practical instructions for compliance.
Early this year, Vietnam’s Ministry of Health introduced Circular 57/2025/TT-BYT (English translation), changing how medical devices are evaluated for public procurement and hospital tenders.
Under the new regulations, hospitals will no longer assess devices only on price or basic performance. They must now also consider technical standards, quality, and regulatory readiness. For medical device manufacturers, the message is clear: strong documentation, standards compliance, and consistent product quality are now critical for tender success. While most attention is paid to device performance under this regulation, medical packaging also plays an important supporting role in meeting these new requirements.
What is Circular 57/2025/TT-BYT?
This Circular introduces a structured framework for classifying medical devices in the context of procurement. It provides guidance on how devices should be grouped based on technical standards (including national, international, regional, or recognised foreign standards) and quality criteria.
This classification framework applies to procurement activities under Vietnam’s Bidding Law, including hospital tenders and public sector purchasing processes.
Circular No. 57/2025/TT-BYT took effect on 15 February 2026, and the medical device classification provisions will take effect starting 1 January 2027. Medical device manufacturers in Vietnam or selling into the Vietnam market should begin compiling documents that show they meet the required technical standards and quality criteria to support a smoother classification review.
Why does medical packaging matter under Circular No. 57/2025/TT-BYT?
Although Circular No. 57 /2025/TT-BYT does not directly regulate medical packaging, packaging forms part of a device’s overall technical and quality profile, especially for sterile medical devices. If the packaging’s documentation is weak or incomplete, it can reduce a device’s classification or weaken a tender submission, even if the device itself meets performance requirements.
Packaging directly impacts a device’s:
- Sterility maintenance
- Shelf-life
- Protection during transport
Together, these factors help reduce risks related to contamination, damage, and device performance.
How does medical packaging support Circular No. 57/2025/TT-BYT requirements?
Meets international technical standards (ISO 11607)
Validated sterile barrier systems, compliant with standards such as ISO 11607, help demonstrate that a device meets technical and quality expectations. This typically includes evidence of:
- Process‑controlled sealing and manufacturing
- Package integrity verified through performance and stability testing
- Documented validation processes
Improves tender submissions and audit readiness
Packaging contributes significantly to the completeness of a tender submission. An experienced packaging supplier can provide:
- Packaging specifications
- Verification and validation summaries (for example, seal strength, ageing, and transport testing)
- Compliance statements aligned with national or international standards
Clear and well‑structured documentation helps reduce questions during tender reviews and regulatory audits.
Protects sterility and reduces risk (supports higher classification)
Robust packaging systems protect devices throughout storage, transport, and shelf‑life conditions. While not always essential, custom-designed packaging can be worth considering, as it is tailored to the device’s form, fit, and function and typically provides better protection than standard off-the-shelf pouches. Poorly designed packaging can allow unnecessary movement, increasing the risk of damage or loss of sterility.
Proper packaging systems also ease audits by ensuring:
- Consistent validation records
- Controlled and well‑documented packaging changes
- Reliable traceability throughout the product lifecycle
5 Key questions to ask your packaging supplier
To prepare for Circular No. 57 /2025/TT-BYT, manufacturers should ask their packaging suppliers the following:
Can you provide ISO certifications and demonstrate compliance with recognised quality standards?
Can you share material data sheets with relevant testing information (e.g. shelf life, storage, and sealing conditions)?
What documentation can you provide to support product evaluation or tender submissions?
(If you are still sourcing for a packaging supplier) Can you provide samples so we can assess the packaging before making a buying decision?
By engaging suppliers early and confirming what documentation and support are available, manufacturers can strengthen their tender submissions.
Circular No. 57 /2025/TT-BYT raises the bar for medical equipment procurement in Vietnam. Success will depend not only on product performance, but also on how well quality, compliance, and readiness are demonstrated. For sterile medical devices, packaging is no longer just a cost, it is a strategic asset. Preparing early and working with a capable medical packaging partner can make a meaningful difference.
