Circular No. 11/2014/TT-BYT on the management of rapid food testing kits

CIRCULAR

Regulations on the management of rapid food testing kits

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On the basis of According to the Food Safety Law on 1June 7, 2010;

The basis for the Government's Decree No. 38/2012/NĐ-CP dated April 25, 2012, detailing the implementation of certain provisions of the Food Safety Law;i Government Decree No. 2/2012/NĐ-CP dated August 31, 2012;

Pursuant to DecreeNo. 63/201At the proposal of the Director of the Food Safety Administration under the Ministry of Health, this Circular stipulates the management of rapid food testing kits.June 2024;This Circular stipulates the examination, registration for circulation, advertising, labeling, and use of rapid food testing kits."b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."structuring the functions, tasks, powers, and organizational structure of the Ministry of Public Security;, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP organizationsDeputy ministers of ministerial-level agencies,the Ministry of Health;

This Circular applies to enterprises producing, trading, importing, and distributing chemicals, testing equipment (hereinafter referred to as enterprises) that propose to register for circulation of rapid food testing kits in Vietnam.rime Minister c;

AND trRapid food testing kits reason include pre-prepared tools, chemicals, or culture media sufficient to test one or more specific food safety indicators, reducing the time required for results compared to standard testing methods.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Registration for circulation

Article 2. Applicability

is the process of implementing procedures as prescribed to assess the scientific nature, practicality, accuracy of rapid testing kits, and the legality of the registration application file to allow circulation through the issuance of a registration certificate.

Article 3. Explanation of Terms

In this Circular, the following terms are understood as follows:

1. Examinationệis the experimental process to prove the characteristics of rapid food testing kits in practice. Article 4. Fees and charges for registration for circulation of rapid food testing kits

2. Enterprises must pay fees and charges when registering for circulation of rapid food testing kits according to the provisions of Circular No. 149/2013/TT-BTC dated October 29, 2013, issued by the Minister of Finance, stipulating the collection, payment, management, and use of fees and charges for food safety management. ADJUSTMENT EXAMINATION OF RAPID FOOD TESTING KITS

3. Testing Article 5. Requirements for examination

1. All rapid food testing kits must undergo examination in Vietnam before being registered for circulation on the Vietnamese market, except for those specified in Clause 2 of this Article.

2. In cases where rapid food testing kits have been recognized or mutually recognized by international organizations such as WHO, FAO, JECFA, AOAC, ISO, or countries with mutual recognition agreements with Vietnam, they are allowed to circulate without needing re-examination.

Chapter II

Article 6. Institutions conducting examinations

Testing institutions meeting the conditions stipulated in Article 7 of this Circular may participate in conducting technical examinations of rapid food testing kits proposed by enterprises.

Article 7. Conditions for institutions conducting examinations

Institutions conducting examinations must meet the following conditions:

1. Have the function of food safety testing;

2. Have a laboratory accredited to standards ISO/IEC 17025 in the field of food testing for the indicators to be examined; or a laboratory designated as a food testing institution serving state management according to Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 1, 2013, issued by the Ministers of Health, Industry and Trade, and Agriculture and Rural Development, stipulating the conditions and procedures for designating food testing institutions serving state management in the field of food testing for the indicators to be examined.

Article 7. Conditions for the facility conducting testing

The facility conducting testing must meet the following conditions:

1. Having the function of food safety testing;

2. Having a laboratory recognized as conforming to standard ISO/IEC 17025 in the field of food testing for the required testing criteria; or a laboratory designated as a food testing facility serving state management according to Circular Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 1, 2013 of the Minister of Health - Minister of Industry and Trade - Minister of Agriculture and Rural Development stipulating the conditions and procedures for designating a food testing facility serving state management, in the field of food testing for the required testing criteria.

Article 8. Procedures for conducting testing

1. Annually, the Food Safety Administration shall publish a list of testing facilities that have the capacity to assess the quality of food rapid test kits for enterprises to choose for testing.

2. Enterprises shall submit a written request for review of the testing results to the Food Safety Administration along with the testing results from three testing facilities chosen by the enterprise from the list of testing facilities published annually by the Food Safety Administration pursuant to Clause 1 of this Article.

3. After receiving all required documents as stipulated in Article 11 of this Circular, the Food Safety Administration shall be responsible for establishing a specialized expert committee to evaluate the food rapid test kits to advise the Director of the Food Safety Administration on reviewing and signing the registration certificate.

4. Enterprises must bear all costs of testing in accordance with the provisions of the law.

Chapter III

REGISTRATION FOR CIRCULATION OF FOOD RAPID TEST KITS

Article 9. Registration for circulation of food rapid test kits

All food rapid test kits produced domestically and imported from abroad into Vietnam (excluding temporarily imported goods for re-export) must obtain a registration certificate from the Ministry of Health before being circulated in Vietnam for testing food safety standards.

The model of the registration certificate for circulation of food rapid test kits is prescribed in Appendix 01 issued together with this Circular.

Article 10. Forms of registration for circulation of food rapid test kits

1. Registration for circulation of food rapid test kits

Enterprises shall submit application documents in accordance with Clause 1 of Article 11 of this Circular.

2. Registration for change and addition to the circulation of food rapid test kits

a) Food rapid test kits that have been granted a registration certificate for circulation, during the validity period of the registration certificate, if there is a change or addition to any registered content, it must be approved in writing by the issuing authority;

b) When changing or adding any of the following contents, enterprises shall submit application documents in accordance with Clause 2 of Article 11 of this Circular; the issuing authority will consider retaining the previously issued registration certificate:

- Changing the shelf life, storage conditions;

- Changing (adding) labeling information;

- Changing the scope of application;

- Changing the detection limit;

- Changing (adding) usage instructions;

- Changing (adding) accuracy (or error) information;

- Changing (adding) packaging specifications.

c) When changing or adding any of the following registered contents, the procedures shall be carried out as registration for circulation:

- Changing (adding) testing criteria;

- Changing the operating principle;

- Changing the testing characteristics;

- Changing the name of the food rapid test kit;

- Changing the enterprise applying for registration.

Enterprises shall submit application documents in accordance with Clause 1 of Article 11 of this Circular; the issuing authority shall revoke the previously issued registration certificate.

3. Extension of registration for circulation of food rapid test kits

Within three months before the registration certificate expires, if enterprises wish to continue registering for circulation in Vietnam, they shall submit extension application documents in accordance with Clause 3 of Article 11 of this Circular.

After the above deadline, if enterprises have not completed the extension procedures, they must submit application documents for registration for circulation in accordance with Clause 1 of Article 11 of this Circular.

The model for extending the registration certificate for circulation of food rapid test kits is prescribed in Appendix 02 issued together with this Circular.

Article 11. Documents for Application to Register the Circulation of Rapid Food Testing Kits

1. Documents for Application to Register the Circulation of Rapid Food Testing Kits

The enterprise shall submit one set of application documents for registration of circulation (the documents must include a list of attached materials) to the Food Safety Administration, which includes:

a) An application form for registering the circulation of rapid food testing kits according to the model prescribed in Appendix 03 issued together with this Circular;

b) A certified copy of the business registration certificate;

c) Research and testing documents related to the rapid food testing kit; in case these documents are in a foreign language, they must be accompanied by a Vietnamese translation (confirmed by the enterprise);

d) Instructions for using the rapid food testing kit; in case the instructions are in a foreign language, they must be accompanied by a Vietnamese translation (confirmed by the enterprise);

đ) A report on the evaluation results of the rapid food testing kit conducted by three testing facilities chosen by the enterprise from the annual list of testing facilities published by the Food Safety Administration;

e) One sample label of the rapid food testing kit including the direct label on the smallest packaging unit and the indirect label on the outer packaging (stamped by the enterprise);

g) A certified copy of the manufacturing or export permit issued by the competent authority of the country of origin (for imported rapid food testing kits) and must be legalized by a consular officer in English or Vietnamese; if the permit is in another language, it must be accompanied by a certified Vietnamese translation;

h) Two sets of rapid food testing samples.

2. Documents for Application to Amend or Supplement Registered Content for Rapid Food Testing Kits

When there are changes or supplements to the contents specified in Clause 2 of Article 10 of this Circular, the enterprise shall submit one set of application documents (the documents must include a list of attached materials) to the issuing authority, which includes:

a) An application form for amending the registered circulation content of rapid food testing kits according to the model prescribed in Appendix 04 issued together with this Circular;

b) A certified copy of the registration certificate (including the original certificate and all renewals, if any);

c) Materials related to the proposed amendments or supplements; in case these materials are in a foreign language, they must be accompanied by a Vietnamese translation (confirmed by the enterprise);

d) Two sets of rapid food testing samples.

3. Documents for Application to Extend Registration of Circulation of Rapid Food Testing Kits

The enterprise shall submit one set of application documents for extending the registration of circulation (the documents must include a list of attached materials) to the issuing authority, which includes:

a) An application form for extending the registration certificate according to the model prescribed in Appendix 05 issued together with this Circular;

b) A certified copy of the registration certificate (including the original certificate and all renewals);

c) One set of rapid food testing samples;

d) A confirmation document from at least one testing facility that has used the rapid food testing kit regarding its stability and specificity.

Article 12. Competence and Procedures for Issuing Certificates of Registration for Food Rapid Test Kits

1. The Ministry of Health delegates the National Food Safety Agency to conduct the review of registration files and issue certificates of registration for food rapid test kits.

2. Procedures for issuing certificates of registration:

a) Receiving registration files;

b) Establishing a specialized expert committee to evaluate food rapid test kits:

- Reviewing, assessing, and concluding on the scientific basis and practicality of the food rapid test kits, advising the Director of the National Food Safety Agency in reviewing and evaluating the food rapid test kits;

- Proposing solutions for registering the circulation of food rapid test kits.

c) Based on the conclusions and recommendations of the committee, the Director of the National Food Safety Agency will decide:

- Permitting circulation: issuing certificates of registration, or renewing certificates of registration (in cases of changes or additions) for each food rapid test kit;

- Requesting additional information and documents before permitting circulation: notifying the enterprise in writing, specifying the required additional information;

- Not permitting registration for circulation: notifying the enterprise in writing, stating the reasons for not permitting registration for circulation.

d) Time limit for responding to enterprises:

- For registration files for food rapid test kits: no more than 20 working days from the date of receiving valid files;

- For registration files for changes or additions to food rapid test kits: no more than 10 working days from the date of receiving valid files;

- For registration files for extending the validity period of food rapid test kits: no more than 5 working days from the date of receiving valid files.

3. Validity period of certificates of registration for food rapid test kits

a) Certificates of registration for food rapid test kits have a validity period of 5 years from the date of issuance.

b) Certificates of registration can be renewed multiple times, with each renewal having a validity period of 5 years from the date of issuance.

c) For food rapid test kits that have been issued certificates of registration according to Decision No. 18/2007/QĐ-BYT dated February 27, 2007 of the Minister of Health on the management regulations for rapid food hygiene and safety tests, which have reached their 5-year validity period, enterprises must follow the procedures for renewing the registration for circulation as stipulated.

Chapter IV

BUSINESS, ADVERTISING, LABELING AND USE OF FOOD RAPID TEST KITS

Article 13. Business of Food Rapid Test Kits

1. Enterprises are only permitted to engage in business of food rapid test kits after obtaining certificates of registration; conducting business of food rapid test kits in accordance with the models and criteria registered.

2. Enterprises shall be responsible for any harm caused by their food rapid test kits failing to meet the registered criteria.

Article 14. Advertising of Food Rapid Test Kits

1. Enterprises are only permitted to advertise food rapid test kits after obtaining certificates of registration.

2. Advertisements for food rapid test kits must comply with the laws on advertising.

Article 15. Labelling of food rapid test kits

1. The product label of food rapid test kits must comply with current laws on product labelling.

2. In addition, the following mandatory information must be included on the label:

a) Registration number for circulation;

b) Safety precautions for circulation and use of food rapid test kits.

Article 16. Use of food rapid test kits in food safety testing

Within the scope of application, food rapid test kits may be used in the following cases:

1. Supporting testing and inspection work for food safety. Results obtained from testing using food rapid test kits are preliminary results, only serving as screening and guiding subsequent confirmatory tests in laboratories. Such results cannot be used as a basis for handling violations;

2. Testing to serve food safety control during production, processing, and trading;

3. Testing to assist consumers in selecting food.

Article 17. Suspension of circulation and revocation of registration certificate for food rapid test kits

1. Food rapid test kits will be subject to a decision by the issuing authority to suspend circulation in the event that the enterprise commits any of the following acts:

a) Modifying or supplementing contents as stipulated in Points b and c Clause 2 Article 10 of this Circular without the consent of the management agency;

b) Providing or advertising information about food rapid test kits not in accordance with the registered content;

c) Food rapid test kits circulating in the market do not match the samples or do not meet the characteristics as registered.

2. The issuing authority shall issue a decision to suspend circulation of food rapid test kits and announce it on the website of the Food Safety Administration.

3. Upon receipt of the suspension decision, the enterprise shall be responsible for:

a) Promptly implementing measures to recall food rapid test kits circulating in the market; at distributors; or sold to customers;

b) Preparing a recall report;

c) Reporting the recall results to the management agency;

d) Implementing corrective measures and reporting the results thereof to the management agency.

4. The enterprise shall bear all costs associated with recalling food rapid test kits.

5. After the enterprise has remedied the violations under Clause 1 of this Article, the issuing authority shall consider allowing the continued circulation of food rapid test kits.

6. If the enterprise continues to commit the acts under Clause 1 of this Article, the issuing authority may consider revoking the registration certificate for circulation.

Chapter V

IMPLEMENTING PROVISIONS

Article 18. Effective Date

This Circular takes effect from June 1, 2014.

Circular No. 13/2010/TT-BYT dated May 12, 2010, issued by the Minister of Health, guiding the management of food rapid test kits, and Circular No. 28/2011/TT-BYT dated June 24, 2011, issued by the Minister of Health, amending and supplementing certain provisions of Circular No. 13/2010/TT-BYT dated May 12, 2010, guiding the management of food rapid test kits, shall cease to be effective from the date this Circular takes effect.

Article 19. Implementation

The Food Safety Administration is responsible for organizing and implementing this Circular.

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals should promptly reflect them to the Food Safety Administration for consideration and resolution.