Importing Sterile Single-Use Devices Into Vietnam: The 2026 Document File

In this guide

• Confirm the product and importer
• Separate customs and market labels
• Route each manufacturer document
• Check what an NMPA certificate supports
• Use the shipment-file matrix and RFQ
• Resolve inconsistencies and enforcement risks
• Request the relevant VEMERIX evidence
• Buyer questions and update triggers

What authorization must exist before a sterile SKU can enter Vietnam?

A distributor preparing its first shipment from a Chinese sterile-device manufacturer needs more than a folder of certificates. The purchase order may name a trade brand, the CFS a device owner, the QMS certificate a manufacturing site, and the Vietnamese declaration a local organization. The useful question is whether those records describe the same purchased configuration and establish the right responsibilities. A shared model-to-document schedule makes the differences visible before stock is committed.

Start with the medical-device framework in Decree 98/2021 as amended, consolidated by the Ministry of Health in Document 08/VBHN-BYT on 6 March 2026. Circular 24/2026/TT-BYT, effective 1 July 2026, continues to direct medical-device risk determination and corresponding management measures to that framework and its implementing rules. It does not replace the shipment’s device classification with a generic customs category.¹¹²

Article 21 identifies two types of số lưu hành: the declaration of applicable standards number for Class A/B, and the circulation-registration certificate number for Class C/D. This resolves a common terminology trap: a Class B declaration and a Class C registration follow different procedures, although both are circulation numbers. Article 21 generally gives circulation numbers indefinite validity, with an exception for emergency-issued numbers. Indefinite validity does not override withdrawal, product expiry or changes requiring regulatory action.¹

For an ordinary new commercial line, verify the appropriate number and its product scope before dispatch. Do not rely on the old transitional import-permit extensions: the specific transitional permissions in Article 76 ran only to 30 June 2025. Equally, do not conclude that all import permits disappeared. Article 48 retains permits for defined situations involving unregistered devices, including research, certain humanitarian purposes and exhibitions. An exhibition or evaluation shipment cannot simply be treated as commercial stock.¹

Separate the product number holder from the importer

Under Article 47(2), an importer of devices with a circulation number must be the number holder or have its authorization. When the holder authorizes another importer, the authorization is also sent to the number-issuing authority and customs. Appropriate storage and transport, or a contract with a capable provider, are required. Article 47(3) says the importer need not prove these conditions during customs formalities; this procedural provision does not remove the underlying duties.¹

For trading Class B/C/D devices, examine the eligibility conditions and declaration under Articles 40–41, including technical personnel and storage and transport suitable for the product. Article 42 provides an exception for devices on the Ministry’s list that may be traded as ordinary goods; their preservation and transport requirements still apply. Ask the local importer to document whether the declaration or the listed exception applies. A blanket demand for a trading certificate for every device would miss that distinction.¹

Keep two authorization relationships separate. The device owner’s letter authorizing the Vietnamese declaration or registration applicant belongs to the product dossier. The circulation-number holder’s authorization of a different importer belongs to the import arrangement. They may involve the same companies, but the parties, purpose and product scope should be checked independently. A distribution contract alone should not be assumed to satisfy both.¹

What belongs on the label at customs and before circulation?

Decree 37/2026/ND-CP was issued and took effect on 23 January 2026. Article 97 repeals the previous goods-labelling decrees, 43/2017 and 111/2021. Its Article 42 separates the original physical label used during import customs clearance from the information required when goods circulate in Vietnam. The official Vietnamese text controls; the linked English translation is an aid to reading it.²¹⁰

The table summarizes Articles 39–44 of Decree 37. A supplier’s foreign-language pouch is therefore not automatically unacceptable at the port because it lacks a Vietnamese supplementary label. Conversely, meeting the original-label rule is not a promise that customs will release the shipment. Confirm product authorization, goods identification and the rest of the declaration separately.²¹⁰

Build the Vietnamese market label from the actual device record

Appendix I item 13 requires the circulation number or import-permit number, lot or serial number, applicable manufacture/expiry information, warnings, instructions, storage guidance and warranty information. It expressly requires expiry information for sterilized and single-use devices, reagents, calibrators, control materials and chemicals. Certain warnings, instructions, storage and warranty information can be provided directly or through clear lookup instructions on the label. This is not permission to dispense with Vietnamese instructions required under Article 22 of the device framework.¹³

Article 44(2) needs careful reading: alongside the general imported-goods provisions on manufacturer and importer identity, its device-specific text identifies the device owner and circulation-number holder, or the organization named on the import permit where no circulation number exists. Have the Vietnamese applicant approve the responsible-party fields against the actual legal roles. Merely translating the exporter’s invoice address can omit the required device owner or number holder.²¹⁰

• Reconcile the name and model against the Vietnamese device record; do not invent a local risk class from a supplier’s Chinese class.
• Map each required lot, date and expiry field to its location on the pouch, box or accompanying information. Use the decree’s date-expression rules rather than introducing a different expiry meaning during translation.
• Translate the authorized warnings and storage conditions. Do not add an unsupported temperature limit, indication or claim to make the label look complete.
• Check the smallest unit actually supplied separately. Article 36 distinguishes units sold separately from goods sold only within secondary packaging.²¹⁰
• Review placement and adhesion without obscuring original mandatory information or compromising the sterile barrier. Document who approves the translated artwork and who applies it.

Article 37 requires legible characters and describes special handling for small packaging that cannot accommodate compulsory information using a minimum font size of 0.9 mm. That number is part of the small-package provisions, not a universal standalone acceptance test for every printed field. Resolve the physical-label and accompanying-information requirements for the actual pack size.²¹⁰

Old artwork also needs a dated decision. Article 98(3) allows compliant goods manufactured, imported, circulated or used before the effective date to continue circulating and being used to their labelled expiry. Article 98(4) separately gives compliant labels and commercial packaging manufactured or printed before that date a two-year use window. Keep proof of when the stock was made or printed; the rules do not authorize newly printed late-2026 artwork to follow superseded requirements.²

Which authentication route does the CFS or authorization letter take?

Vietnam deposited its Apostille Convention accession on 31 December 2025; the Convention entered into force for Vietnam on 11 September 2026. Decree 293/2026 took effect on the same day. These dates matter to a manufacturer assembling a dossier, but an apostille is an authentication mechanism rather than a device approval or a certification that the document’s contents are true.⁴⁵⁷

Article 25 of Decree 293 exempts qualifying public documents with valid apostilles from further consular legalization when the Convention applies between the issuing state and Vietnam. Articles 26–27 preserve refusal and authenticity checks. The apostille does not prevent rejection for a legally inadequate dossier, an excluded document, a forged record or an invalid certificate. Check both the authentication route and the substantive product evidence.⁴

This routing table is a synthesis of the Convention, Decree 293 and the device-dossier provisions. For a CFS, confirm that the issuing jurisdiction and receiving authority treat that certificate as a qualifying public document. For a private LOA, confirm the public notarial or official certification that will be authenticated. The treaty’s commercial/customs exclusion is narrow; neither “used in business” nor “has a corporate seal” settles whether a particular document qualifies.¹⁴⁷

Check the bilateral relationship before ordering an apostille

The HCCH notifications record objections to Vietnam’s accession from Germany on 20 May 2026, Austria on 19 June 2026 and Czechia on 2 July 2026. Article 12 of the Convention and Article 5(4) of Decree 293 mean it does not apply between Vietnam and an objecting state. Thailand’s status-table entry shows an entry-into-force date of 28 February 2027, still in the future at this review. Recheck the relevant state and territory before commissioning authentication; a general count of member countries does not answer the bilateral question.⁴⁵⁶⁷

For a China-to-Vietnam file, identify which papers are Chinese public documents and which are manufacturer-signed instruments requiring a notarial or official certification. Obtain the apostille from a competent authority in the state where the qualifying document originates. Ask for the proposed route and completion date before commissioning it. This guide does not assign a universal turnaround time or assume that every document in a Chinese export file follows the same chain.⁴⁷

Do not discard correctly legalized historical documents just because the treaty took effect. Article 36(2)(a) of Decree 293 preserves the use in Vietnam of qualifying foreign public documents already consular-legalized before its effective date and prohibits demanding a replacement apostille for them. That preserves authentication; it does not extend the underlying CFS validity, renew an expired LOA or correct a changed product scope.⁴

Translation and copy requirements remain document-specific

The device rules do not require a notarized Vietnamese translation of every foreign-language paper. Articles 27 and 31 distinguish documents: QMS certificates and specified circulation/CFS evidence in English or Vietnamese do not trigger the same translation requirement as documents in other languages; Vietnamese IFU submissions have their own provisions. Where a translation is required under those clauses, it must be certified as prescribed. Record the language, copy form and authentication requirement separately for each document.¹

For apostilled public documents, Article 27(1) of Decree 293 sets a default of a notarized or certified Vietnamese translation unless specialized legislation provides otherwise. Apply the device rules’ English-language exceptions only to the document types they identify; do not automatically extend them to every authorization letter.⁴¹

This matters commercially. A request for “all documents apostilled and notarized in Vietnamese” can create unnecessary work while missing the one authorization letter that actually needs authentication. Before commissioning translation or legalization, the Vietnamese applicant should approve a document schedule listing the source language, accepted copy form, required translation and authentication route. For generic CFS authenticity checks, use the Certificate of Free Sale verification guide; then apply Vietnam’s additional requirements to that verified document.

Where does an NMPA registration help?

Article 29(2)(a) includes a CFS or market authorization from China’s central-level NMPA among the evidence supporting accelerated issuance of a new circulation number. That wording is narrower than “any Chinese registration certificate.” Do not assume that a provincial Class II certificate meets this specific reference-authority condition. Ask the Vietnamese applicant to identify the exact Article 29 basis and the qualifying evidence for the proposed route.¹

The supplier’s registration remains useful for product identity and due diligence even when it does not establish accelerated-route eligibility. Check it using the NMPA registration-certificate verification guide. An NMPA document never substitutes for the Vietnamese circulation number. Likewise, an MDSAP audit certificate is QMS evidence rather than the CFS or product market authorization named in Article 29. No clinical-evidence waiver or guaranteed review time should be inferred from either document.¹

For procurement planning, record the proposed Vietnamese route, evidence supporting eligibility, application status and unresolved queries. Set the dispatch milestone against the authorization actually obtained, rather than a consultancy’s estimated review duration. If the registration is still pending, keep the commercial release decision open; an estimated approval month is not an authorization to ship ordinary sale stock.

Who owns each part of the shipment file?

The matrix below is a buyer’s coordination tool, not a statement that every row is a separate customs attachment or that it exhausts every legal obligation. It separates dossier evidence, importer responsibilities, shipping records and market-release controls. Complete it for the exact SKU and legal entities, adding the application or document reference, responsible person, current version and unresolved action to each row.

The regulatory rows derive from the device framework and Decree 37; the staging, owner assignment and hold decisions are editorial procurement recommendations. A practical implementation is a shared schedule with one line for each ordered model. Reference the supporting certificate and label version rather than pasting an entire manufacturer dossier into the purchase order.¹²³

What should the manufacturer RFQ request?

• Identify the parties: “Please identify the device owner, legal manufacturer, manufacturing site and exporter for each quoted SKU, and explain differences across the proposed CFS, LOA, QMS certificate and packaging.”
• Agree the authentication schedule: “Before commissioning authentication, submit the issuing country, document type, accepted original/copy form, translation language and proposed apostille, consular or exemption basis for the Vietnamese applicant’s review.”
• Separate authorization letters: “Confirm who will issue the owner-to-applicant authorization for the product dossier and, if needed, the number-holder-to-importer authorization. State product scope and validity for each.”
• Approve both label states: “Supply actual pouch and carton artwork before production approval. Identify the original-label fields for customs and the Vietnamese information to be added before circulation. Agree who approves, applies and records the supplement.”
• Define lot evidence: “Agree the lot-release and sterilization records relevant to this product, and how each shipped lot will link to the approved configuration and expiry.” Treat this as a quality-agreement requirement, not a claim that a generic CoA proves every sterility or packaging characteristic.
• Control changes: “Notify the buyer before changes to the device owner, manufacturing site, model, intended use, label or document validity. Obtain the local applicant’s assessment before shipping the changed configuration.”

Keep the RFQ product-specific. A sterile single-use product should not acquire an equipment-warranty document by copying a reusable-equipment checklist: Article 22 recognizes the single-use/no-warranty boundary, and Article 26 also addresses dossier warranty evidence. Have the applicant mark the requirement applicable or exempt with its basis. The same discipline applies to testing and sterilization records: request evidence relevant to the actual device and process, rather than imposing an assumed EO or radiation cycle on every SKU.¹

Which inconsistencies should stop dispatch?

Use an internal hold when a discrepancy prevents the team from establishing what the shipment is or why it can be imported. This is a procurement recommendation; it is not a prediction that every mismatch automatically produces seizure, a fixed delay or detention of an entire container. Customs handling depends on the goods, declaration and applicable rules.

• Model mismatch: A quotation adds a suffix absent from the Vietnamese product record. Ask whether it is a covered variant or a change requiring regulatory action; do not silently shorten the code on the invoice.
• Party mismatch: The CFS names a device owner different from the exporter. Obtain the relationship and manufacturing-site explanation; different roles are not automatically misconduct.
• Label mismatch: A Vietnamese supplement changes the storage statement or claimed use. Resolve against the authorized product information before application.
• Authentication mismatch: A German-issued public document has an apostille chosen because the exporter is based in China. Reassess the issuing jurisdiction and bilateral route.
• Lot mismatch: The packing list, physical goods and lot-release record identify different batches or expiry dates. Reconcile the actual goods before approving the shipment.
• Customs-data mismatch: Descriptions, origin or declared values differ across records. Have the customs representative resolve the applicable classification, origin and valuation questions; this guide supplies no HS-code or tariff determination.

Use the current offence and the correct penalty basis

Decree 90/2026/ND-CP governs healthcare administrative sanctions from 15 May 2026, replacing the older Decree 117/2020 regime. Its medical-device provisions distinguish trading, importation and other activities. Do not use a single invented “documentation penalty” for every discrepancy.⁸⁹

Article 75 addresses medical-device import violations, including an importer of registered devices failing to satisfy the required conditions. It provides a VND 20–30 million fine for the listed acts and related business suspension of one to three months. Article 4 makes Chapter II fines individual amounts; the same violation by an organization attracts twice that fine. These are offence-specific provisions, not the automatic cost of any typo, missing label or shipment delay.⁸⁹

For comparison, Article 74 covers trading duties, including traceability and eligibility requirements, with its own clauses and sanctions. A labelling issue must be assessed under the applicable labelling and other relevant rules rather than assigned Article 75’s import-condition fine. Before accepting an enforcement estimate, record the exact act, clause, liable entity and possible remedial measure. A correction plan should close the defect and its cause; budgeting a fine does not make non-compliant stock releasable.⁸⁹

Where VEMERIX fits—and where due diligence still begins

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.

The portfolio includes disposable circumcision staplers, disposable medical laser fiber and NPWT dressings. Medison’s single-use medical laser fiber pairs with a partner-supplied diode laser source. These are relevant product families for a distributor’s evidence request; their inclusion here does not establish a Vietnamese risk class, registration or import authorization.¹¹

Send the target market, exact SKU/size range, intended use and proposed Vietnamese applicant when requesting a Vietnam document and artwork discussion. Ask which current manufacturer records are available, which require authentication or translation, and who will obtain them. Confirm scope, timing and responsibility in writing. A general company capability statement does not establish availability of a complete Vietnam-ready dossier or an apostille service for a particular SKU.

Frequently asked questions

Is an ISO 13485 certificate enough to import?
No. It is QMS evidence within the applicable dossier. Check the Vietnamese product authorization and importer duties separately. Articles 26–27 distinguish the QMS certificate’s validity and copy requirements from CFS and authorization-letter formalities.¹

Must the factory print a complete Vietnamese label before shipment?
The original physical label must meet Article 42(2) during customs clearance; missing Vietnamese circulation information must be supplemented before domestic circulation. Decide the final location and application process for the actual pouch/box configuration. Keeping an intact original label does not remove the remaining market-label duties.²³¹⁰

Does every LOA need the same apostille?
No. Identify whether it is a device-owner authorization for the applicant or a circulation-number holder’s authorization of the importer, then check the applicable formalities. A private signature requiring treaty authentication needs a qualifying public notarial or official certification; an apostille does not validate the scope of the commercial appointment.¹⁴⁷

Do we need to replace a pre-September consular-legalized CFS?
Not merely because the apostille regime began. Decree 293 preserves qualifying foreign public documents legalized before its effective date. Still verify the CFS’s own validity, product scope and accepted dossier form.⁴

Can an NMPA Class II certificate establish accelerated eligibility?
Not automatically. Article 29 names China’s central-level NMPA among the reference authorities. Have the Vietnamese applicant establish whether the particular evidence satisfies that route or another applicable basis. The Chinese certificate itself does not authorize Vietnamese import or circulation.¹

What should trigger another review of this file?
A new product variant or intended use, changed owner or manufacturing site, importer change, revised label, expiring supporting document, new legal instrument or changed treaty relationship should trigger reassessment. Recheck the official device framework, current goods-labelling rules and HCCH bilateral status before the next shipment. This guide is a dated document-coordination framework; the actual application and shipment determine the remaining requirements.