Quick summary
- Since 2026, conformity assessment bodies (CABs) in Vietnam operate on two separate but stacked legal lanes: registration of activities under Decree 22/2026/ND-CP dated 16 January 2026 (Chapter V, Articles 42 – 64) and designation under Decree 37/2026/ND-CP dated 23 January 2026 (Section 2, Chapter VII, Articles 71 – 78).
- Registration is the licence to practise: every testing laboratory, inspection body, certification body, validation/verification body and accreditation body must hold a Certificate of Registration of Activities — corresponding to five competence standards: ISO/IEC 17025 – 17020 – 17065/17021-1 – 17029 – 17011.
- Designation is the licence to serve state management: it arises only where a national technical regulation (QCVN) or specialised law requires the CAB to be designated, and only for high-risk products and goods under the responsibility of a line ministry.
- Designation does not replace registration: Articles 71 and 72 of Decree 37 require the body to already hold a Certificate of Registration of Activities in the exact scope applied for, and to be accredited for that scope.
- The two lanes have different issuing authorities: registration by the Chairman of the provincial People’s Committee (testing, inspection, certification) or the Ministry of Science and Technology (accreditation bodies); designation by the line ministry (or the provincial People’s Committee for local technical regulations).
- The two lanes have different reporting rhythms: under Decree 22, CABs update results weekly and accreditation bodies before the 20th of each month; under Decree 37, a designated body reports quarterly, before the 25th.
- Commercial impact: registered means you can sign service contracts on the market; designated means your results can be used by state inspection, your name appears on the ministry’s published list, and other ministries may recognise your competence assessment.
1. Why the “registration” and “designation” lanes are so often confused
Advising testing laboratories, inspection bodies and certification bodies, the question we have heard most often since 2026 is: “Our factory already has ISO/IEC 17025 and a Certificate of Registration of Testing Activities — why can’t we test this imported consignment that is subject to state inspection?” The answer lies in the second lane.
The current legal architecture is built on two different levels of competence:
- Level 1 — competence to practise (registration of activities). Decree 22/2026/ND-CP consolidates all business conditions for conformity assessment services into Chapter V (Articles 42 – 64), replacing Decree 107/2016/ND-CP, Decree 127/2007/ND-CP and the previously scattered rules. This is the minimum condition to exist lawfully on the market: competence, personnel, equipment, management system — recognised by the state through a certificate.
- Level 2 — standing to serve state management (designation). Decree 37/2026/ND-CP devotes Section 2, Chapter VII (Articles 71 – 78) to the designation of CABs. This is not a “business licence” but an administrative decision granting a body a specific service scope tied to a state management requirement, with the consequence that its conformity assessment results are used by state inspection authorities.
The two instruments were issued exactly seven days apart (16 and 23 January 2026) and both implement the two 2025 amending laws — the Law on Standards and Technical Regulations (as amended) and the Law on Product and Goods Quality (as amended). Reading Decree 22 without Decree 37 (or vice versa) will therefore almost certainly lead to wrong dossier design and wrong commitments to clients.
A quick way to remember: Decree 22 answers “Am I allowed to practise?”; Decree 37 answers “Will the state use my results?”. Holding a Certificate of Registration of Activities without designation still lets you practise normally — but keeps you out of the market that the state designates.
2. Lane one — Registration of activities under Decree 22/2026/ND-CP
2.1. Five service categories that must register, and the matching competence standards
Chapter V of Decree 22/2026/ND-CP is divided into six sections, the first five of which cover the five conformity assessment service categories subject to registration:
| Service category | Articles | Mandatory competence standard | Minimum personnel |
|---|---|---|---|
| Testing of product and goods quality | Articles 42 – 45 | TCVN ISO/IEC 17025 or ISO/IEC 17025, or a specialised national/international standard | 06 official testing staff; when adding a field: +01 per field |
| Inspection of objects within the standards and technical regulations field | Articles 46 – 49 | TCVN ISO/IEC 17020 or ISO/IEC 17020 | 06 inspectors; each with ≥ 02 years of direct inspection work and ≥ 20 inspection assignments confirmed by the body; when adding a field: +02 inspectors |
| Certification of products and of management systems | Articles 50 – 53 | TCVN ISO/IEC 17065 (products) or TCVN ISO/IEC 17021-1 (management systems), with relevant IAF guidance | 06 official assessment experts (university degree or higher; assessment skills training under the MoST framework programme) |
| Validation and verification | Articles 54 – 57 | TCVN ISO/IEC 17029 or ISO/IEC 17029, or a specialised, sector-specific standard | 06 official experts; ≥ 02 years of relevant experience; ≥ 20 person-days of participation |
| Accreditation of conformity assessment bodies | Articles 58 – 62 | TCVN ISO/IEC 17011 or ISO/IEC 17011 | 06 official assessment experts, including 01 lead assessment expert per accreditation programme |
Three technically important points deserve emphasis:
- Article 3 of Decree 22 defines the roles for the first time (testing staff, inspector, assessment expert) and converts a “person-day” into 08 working hours, listing exactly which activities count (opening meeting, document review, exchange of information, assignment of guide and observer roles, collection and verification of information and data, raising findings, preparing conclusions, closing meeting). This is the basis for no longer under- or over-counting competence dossiers.
- Personnel must be official staff of the body — public employees, or employees on fixed-term contracts of 12 months or more, or on indefinite-term contracts. Case-by-case contractors do not count towards the threshold of 06.
- For accreditation bodies, Article 58 imposes a conflict-of-interest rule: founders, managers and directors of the accreditation body may not at the same time manage, direct or hold shares in any CAB in the same field for which accreditation is granted — and the body must be a signatory to the MRA/MLA of ILAC, IAF or APAC, or be recognised under an MRA/MLA to which Vietnam is a party.
2.2. Authority, dossier and timelines: the new decentralisation
| Item | Rule under Decree 22/2026/ND-CP |
|---|---|
| Receiving and issuing authority | The Chairman of the provincial People’s Committee assigns a specialised agency to receive registration dossiers for testing, inspection and certification (Articles 43, 67). Where the field is multi-sector and falls under two or more line ministries, the province appoints a single focal agency. Accreditation bodies work with the Ministry of Science and Technology (Articles 58 – 62, 64). |
| Filing channel | Online public service via the National Public Service Portal, connected to and sharing data with the National Database on Standards, Metrology and Quality. Paper filing (in person or by post) is allowed only when the portal fails or the online infrastructure is not yet complete (Articles 44, 48, 52, 56, 60). |
| New registration dossier (testing example) | Application form (Form No. 01); certificates and documents for each staff member (recruitment decision or labour contract, training certificates); list of machinery, equipment and instruments (Form No. 04); evidence of management-system competence — where the body is already accredited by a registered Vietnamese accreditation body or a foreign accreditation body, that accreditation may be used as evidence (Article 43). |
| Processing times | 03 working days to notify any request to amend or supplement an incomplete dossier. 07 working days from receipt of a complete, valid dossier to issue the Certificate (Articles 45, 49, 53, 57, 61). |
| Validity and form | The Certificate is valid for up to 05 years from the date of issue. An electronic Certificate has the same legal value as a paper one. Supplementary/amended certificates apply to widening or narrowing the scope; re-issue applies to changes of name or address, or loss or damage of the paper original. |
2.3. Maintenance obligations — the part most bodies forget
Registration is not a one-off procedure. Article 68 of Decree 22 creates a set of ongoing obligations:
- CABs must update and declare their conformity assessment results weekly — “before the first day of the following week” — on the National Database on Standards, Metrology and Quality, using Form No. 07, 08 or 09 depending on the category (certification; testing; inspection/validation/verification).
- Accreditation bodies must report before the 20th of each month, covering the period from the 16th of the previous month to the 15th of the reporting month (Form No. 16).
- Any change affecting registered competence must be updated within 15 days of the change (key personnel, equipment, scope, location, etc.).
- Registration, reporting and updating procedures are all carried out electronically through the National Public Service Portal and the National Database; the body is responsible for the accuracy, truthfulness and legal validity of electronic data and must ensure technical infrastructure, information security and digital signatures.
One point with teeth: Article 63 lists the cases in which a Certificate of Registration of Activities is revoked, including failure to fully perform the duties under Article 68 for 02 years. In other words, failing to report on time can cost you your certificate — a purely operational risk with very heavy legal consequences. For accreditation bodies, Article 64 adds that after revocation for violations, failure to meet conditions or forged dossiers, the body may only be considered for re-registration after 02 years.
3. Lane two — Designation under Decree 37/2026/ND-CP
3.1. When does the designation obligation arise?
Article 71 of Decree 37/2026/ND-CP sets out two triggering conditions:
- A documentary condition: a QCVN or specialised law requires the CAB to be designated. If the QCVN does not require it, businesses may still use results from a merely registered body.
- A subject-matter condition: high-risk products and goods under the responsibility of a line ministry. The three risk levels (high – medium – low) are determined under Article 4 of Decree 37, based on scientific evidence, practical data, the state’s management capacity and the proportionality principle.
As to authority, the line ministry designates CABs for its own sector, while the provincial People’s Committee designates certification bodies for local technical regulations (QCĐP) issued by that province. The list of designated bodies and the list of foreign CABs recognised unilaterally must be published publicly, connected to the National Database and updated before the 25th of each month.
3.2. Designation conditions: registration is a precondition
This is the direct answer to the question in section 1. Under Article 72, a testing body must simultaneously have:
- A Certificate of Registration of Testing Activities under the law on standards and technical regulations, covering the testing field applied for designation — i.e. it must already be on lane one;
- Accreditation by a registered accreditation body, for exactly the scope applied for and, where applicable, for the field serving the ministry’s state management requirements;
- Satisfactory proficiency testing (PT) or interlaboratory comparison results for the test methods of the products and goods applied for;
- At least 06 official testing staff, each with at least 02 years of experience in the field applied for designation.
For certification bodies, verification bodies and validation bodies, the baseline is likewise a Certificate of Registration of Activities in the corresponding category and accreditation for the scope applied for. For certification bodies, Article 72 further requires 06 official assessment experts and at least 20 person-days of assessment experience for the products and goods applied for — with special rules for new programmes (for example, for a new product certification programme or an added product scope: at least 05 person-days on products of the same family).
Practitioner’s note: The correct sequence is (1) register activities → (2) obtain accreditation → (3) achieve satisfactory PT/interlaboratory results → (4) apply for designation. Many bodies do it backwards: they file for designation while the accreditation certificate does not yet cover the exact scope, or their PT evidence covers only their own methods. Both mistakes get the dossier rejected at the review stage.
3.3. Dossier and designation procedure
| Step | Content | Time limit |
|---|---|---|
| Filing | Online public service via the National Public Service Portal (paper filing only when the system fails) | — |
| Completeness check | The designating authority notifies any request to amend or supplement the dossier | 03 working days |
| Decision to conduct an on-site competence assessment | Based on personnel, technical facilities, quality management system, operating results and legal compliance; carried out through an expert or an assessment team | 10 working days |
| On-site assessment & report | The assessment team must include a member trained in the quality management system for that type of body, and must notify the body in writing in advance | Report sent to the authority within 05 days |
| Corrective action | The body submits a corrective action report; where more time is needed it must report in writing stating the final completion date | ≤ 30 days, extendable to at most 06 months |
| Lighter cases | Temporary designation, changes, additions or narrowing of scope: dossier review only, no on-site competence assessment — unless the dossier contains unsuitable content, a competent authority requests it, or there is information or a complaint indicating a violation | — |
One mechanism is particularly noteworthy — mutual recognition between ministries: where a body has already been assessed and designated by another line ministry, the new designating authority recognises the corresponding quality management system assessment results when conducting the on-site assessment; recognised assessment results are valid for 12 months from the date the most recent assessment result was issued. In principle, Article 71 also requires ministries to consider and use each other’s assessment results within their management scope — a mechanism businesses should actively invoke to remove duplication.
3.4. Rights, obligations and consequences
- Rights: to perform conformity assessment for high-risk products and goods under the responsible ministry; to be published on the list of designated bodies; and, most importantly, to have results used by state inspection authorities.
- Operating obligations (Article 77): maintain competence and comply with the scope, methods and technical requirements of the QCVN or specialised law; report quarterly before the 25th (or ad hoc) on designated conformity assessment results on the National Database; notify the designating authority of any change affecting competence within 15 days; and, for designated testing bodies, participate in PT/interlaboratory comparison at least once during the validity of the designation decision for the designated field and products.
- Consequences of violation (Article 76): revocation of the designation decision for two consecutive violations of conformity assessment rules; failure to fully perform the duties under Article 77 for two consecutive years; failure to meet designation conditions; forging or falsifying dossier documents or issuing results without testing; altering the designation decision; failure to remedy violations at the request of inspection authorities; or no longer operating within the designated scope. After revocation, a body may only be considered for a new designation dossier after at least 06 months from the revocation notice, provided the violations are remedied.
4. Side-by-side comparison of the two lanes
| Criterion | Registration of activities — Decree 22/2026/ND-CP | Designation — Decree 37/2026/ND-CP |
|---|---|---|
| Legal nature | Licence to practise (certificate of competence) | Administrative decision granting a service scope for state management |
| Legal basis | Law on Standards and Technical Regulations; Chapter V, Articles 42 – 64 | Law on Product and Goods Quality; Articles 71 – 78 |
| Mandatory for whom | Every testing, inspection and certification body, validation/verification body and accreditation body | Only where a QCVN or specialised law requires it, for high-risk goods under an assigned ministry |
| Competence standards | 17025 / 17020 / 17065 / 17021-1 / 17029 / 17011 | The same, plus: accreditation certificate for the exact scope; satisfactory PT/interlaboratory results |
| Personnel | ≥ 06 official staff (testing staff / inspectors / assessment experts) | ≥ 06, with experience criteria: ≥ 02 years (testing staff); ≥ 20 person-days (certification); ≥ 02 years + 20 assignments (inspection) |
| Issuing authority | Chairman of the provincial People’s Committee (testing, inspection, certification); MoST (accreditation) | Line ministry; provincial People’s Committee for local technical regulations |
| Filing channel | National Public Service Portal (paper only if the system fails) | National Public Service Portal (paper only if the system fails) |
| Processing time | 03 days to supplement + 07 working days to issue the certificate | 03 days to supplement + 10 working days for the assessment decision, then assessment and correction (≤ 30 days, up to 06 months) |
| Resulting document | Certificate of Registration of Activities — valid up to 05 years; the electronic version equals the paper one | A designation decision by scope; temporary designation is possible |
| Reporting rhythm | Weekly result updates (CABs); before the 20th monthly (accreditation bodies); changes within 15 days | Quarterly, before the 25th; changes within 15 days; PT at least once per designation term |
| Revocation | Articles 63 (CABs) and 64 (accreditation bodies — wait 02 years before re-registering) | Article 76 — wait 06 months and remedy violations before reapplying |
| Commercial effect | Can operate and sign service contracts on the market; serves voluntary business needs | Can supply results for state inspection; published on the ministry’s list; other ministries recognise the competence assessment |
5. Why CABs serving the state need both
Legally, designation is layered on top of registration, not a substitute for it. The matrix below describes the real operating space of a conformity assessment body:
| Not yet designated | Designated | |
|---|---|---|
| Holds a Certificate of Registration of Activities | Lawful practice on the market: testing, inspection and certification for business clients, including declaration of conformity where the technical regulation does not require a designated body | Full service territory: supply of results for state inspection of high-risk goods; publication on the list; mutual recognition between ministries |
| No Certificate of Registration of Activities | No legal basis to practise | Impossible — Article 72 makes the registration certificate a precondition |
Three practical consequences:
- For importers and manufacturers of high-risk goods: results used for state inspection must come from a designated body. Choosing a partner that only holds registration will get the dossier rejected and the goods held at the border. Conversely, for medium-risk goods already declared, Decree 37 (Article 86) adds a mechanism removing the need to repeat the declaration of conformity on import — but the test results must still come from a body that is accredited or designated as required.
- For CABs: designation is the key that unlocks the state-sector revenue stream (import quality inspection, market surveillance testing, QCVN certification). But the advantage comes with a dual obligation: maintaining competence under Decree 22 and maintaining the designation scope under Decree 37 — two dossiers, two reporting rhythms, two regulators.
- For accreditation bodies: they are the control point for both lanes, because an accreditation certificate is required both for the registration dossier (as evidence of management-system competence) and for the designation dossier.
6. Six real situations from our advisory practice
- (1) A newly established laboratory wanting to serve both the market and the state: the correct route is register testing activities → obtain ISO/IEC 17025 accreditation → proficiency testing / interlaboratory comparison → apply for designation in the sector. Bodies that invert the order lose three to six months.
- (2) A lab with ISO/IEC 17025 but no registration: it may not practise under Decree 22. Accreditation is evidence of competence, not a licence. This is the most common misunderstanding among FDI businesses.
- (3) A certification body designated for one sector wanting a second: use the change or addition of designation scope route — dossier review only, but the expert experience requirements of Article 72 still apply (for a new product programme: at least 05 person-days on products of the same family).
- (4) A body already designated by one ministry now applying to a second: request recognition of competence assessment results (valid 12 months) to shorten the on-site assessment.
- (5) An importer whose dossier was returned because the service provider was not designated: before signing, check two things — a valid Certificate of Registration of Activities in the right field, and a designation decision from the correct line ministry for that very product or goods.
- (6) A foreign accreditation body accrediting in Vietnam: it must notify the Ministry of Science and Technology at least 20 days in advance and report the results afterwards; non-compliance means its accreditation certificates are not recognised in Vietnam — directly affecting the designation dossier of the Vietnamese body it accredited.
7. Ten common mistakes and a review checklist
Ten mistakes:
- 1. Treating the “Certificate of Registration of Activities” and the “designation decision” as the same thing.
- 2. Applying for designation while the accreditation certificate does not yet cover the exact scope.
- 3. Using PT/interlaboratory results that do not match the test methods of the products and goods applied for.
- 4. Counting contractors or short-term staff towards the threshold of 06 people.
- 5. Forgetting the 15-day change update required by both decrees.
- 6. Skipping the weekly report (Decree 22) or the quarterly report before the 25th (Decree 37) — risking loss of the certificate or the designation decision.
- 7. Filing on paper while the National Public Service Portal is still operational (paper is allowed only on system failure or incomplete online infrastructure).
- 8. Not checking compatibility between the accreditation scope and the designation scope product group by product group, HS code by HS code, programme by programme.
- 9. For designated testing bodies: omitting the PT at least once during the designation term.
- 10. Not monitoring the list of designated bodies published before the 25th of each month — choosing an unsuitable partner or relying on an expired designation.
Ten-point checklist before signing a conformity assessment contract: (1) what risk level is the product; (2) does the applicable regulation require a designated body; (3) does the partner hold a valid registration certificate in the right field; (4) does the partner hold a designation decision from the right ministry for the right scope; (5) is the accreditation certificate valid for that scope; (6) does the assessment method suit the risk level under Circular 14/2026/TT-BKHCN; (7) do key personnel meet the threshold of 06 and the experience criteria; (8) is the PT/interlaboratory evidence still valid; (9) is the partner suspended or revoked (check the published list on the National Database); (10) does the contract address change notification and file handover if the scope changes.
8. A 12-month roadmap for CABs that want both lanes
| Phase | What to do | Control reference |
|---|---|---|
| Months 1 – 2 | Gap review of personnel (threshold of 06, contracts of ≥ 12 months), equipment and scope; choose priority fields | Articles 42, 46, 50, 54, 58 of Decree 22 |
| Months 2 – 4 | Complete the management system to the relevant standard (17025/17020/17065/17021-1/17029); prepare the registration dossier using Forms 01 – 04 | Chapter V of Decree 22 |
| Months 4 – 6 | File through the National Public Service Portal; monitor the 03-day/07-day milestones; obtain the certificate (valid up to 05 years) | Articles 43 – 45, 67 |
| Months 6 – 8 | Work with an accreditation body (17011) for the exact scope intended for designation; enrol in PT/interlaboratory comparison with at least 02 other designated testing bodies | Article 58 of Decree 22; Articles 72, 73 of Decree 37 |
| Months 8 – 10 | File the designation dossier (Forms 4, 7, 8, 9 of Appendix VII) through the National Public Service Portal; prepare for the on-site assessment | Articles 73 – 75 of Decree 37 |
| Months 10 – 11 | Close out assessment findings (≤ 30 days, up to 06 months); receive the designation decision; verify your name on the published list | Articles 75, 71 of Decree 37 |
| Months 11 – 12 | Set up routine compliance: weekly/monthly reporting (Decree 22), quarterly reporting before the 25th (Decree 37), 15-day change updates, digital signature controls | Article 68 of Decree 22; Article 77 of Decree 37 |
Related reading:
- Designation of conformity assessment bodies under Decree 37/2026/ND-CP: conditions, dossier and procedure — the detail of lane two.
- Decree 37/2026/ND-CP: overview of 8 chapters and 99 articles — risk classification and state inspection in context.
- The 8 certification methods under Circular 14/2026/TT-BKHCN — choosing the method by risk level so results are accepted.
- Appendix I of Decree 37/2026/ND-CP: lookup table of 69 groups of goods — establish the product group to know whether designation is required.
- Circular 36/2026/TT-BKHCN: full text of the medium- and high-risk goods list — determine the risk level of the product.
- Circular 16/2026/TT-BKHCN: signing and implementing mutual recognition arrangements — the MRA/MLA mechanism cited by both decrees.
- Conformity assessment procedure 2026: household electrical appliances and ICT equipment — a real dossier example for the electrical and electronics group.
- Circular 125/2026/TT-BCA: surveillance cameras enter the medium-risk list — how a ministry triggers conformity declaration obligations.
Conclusion
From 2026, the legal story of a conformity assessment body in Vietnam is no longer contained in a single licence. Decree 22/2026/ND-CP builds lane one — registration of activities — with five service categories, the corresponding international competence standards, issuance authority decentralised to the provinces, and a dense set of electronic reporting duties. Decree 37/2026/ND-CP builds lane two — designation — which opens only where a QCVN or specialised law requires it, and only to bodies that are registered, accredited and have satisfactory proficiency testing results.
Three propositions to remember: (1) registration is the licence to practise, designation is the licence to serve the state — one does not replace the other; (2) the sequence cannot be inverted: registration → accreditation → proficiency testing → designation; (3) maintaining both lanes is an ongoing obligation, with two reporting rhythms and two regulators — breaching reporting duties can cost the certificate or the designation decision.
For manufacturers and importers, the immediate task is to check two sets of documents from the conformity assessment provider before signing. For CABs, the immediate task is to review the gap between actual competence scope — registered scope — accreditation scope — designation scope, because only when these four scopes align does competence turn into revenue.
References
The following texts are the basis of this article; readers should consult the current versions on the Government Portal and the Official Gazette.
- Decree No. 22/2026/ND-CP dated 16 January 2026 of the Government detailing a number of articles and measures for organising and guiding the implementation of the Law on Standards and Technical Regulations (in force from the date of signing) — vanban.chinhphu.vn; PDF.
- Decree No. 37/2026/ND-CP dated 23 January 2026 of the Government detailing a number of articles and measures for organising and guiding the implementation of the Law on Product and Goods Quality (Articles 71 – 78 on designation of conformity assessment bodies).
- Law on Standards and Technical Regulations No. 68/2006/QH11, as amended by Law No. 35/2018/QH14 and Law No. 70/2025/QH15.
- Law on Product and Goods Quality No. 05/2007/QH12, as amended by Law No. 78/2025/QH15.
- Decrees No. 107/2016/ND-CP, No. 127/2007/ND-CP, No. 78/2018/ND-CP and No. 154/2018/ND-CP (business conditions for conformity assessment services, which ceased to have effect under Article 69 of Decree 22/2026/ND-CP).
Let’s talk
This article is our interpretation for the purpose of disseminating legal knowledge on standards, metrology and quality; it is not a legal normative document. The content restates Decree No. 22/2026/ND-CP dated 16 January 2026 and Decree No. 37/2026/ND-CP dated 23 January 2026 of the Government; the referenced documents may be amended, supplemented, replaced or repealed. Application to any specific case depends on the applicable technical regulation, the risk level of the product or goods and the status of the conformity assessment body; before applying, readers should consult the current official texts and seek advice from the competent authority. The content is for reference only and does not replace legal advice.


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