Circular No. 22/2009/TT-BKHCN guides the procedures and formalities for registering new products that have the potential to cause safety hazards under the management responsibility of the Ministry of Science and Technology.

 

CIRCULAR

GUIDELINES ON THE PROCEDURES FOR REGISTRATION OF NEW PRODUCTS WITH POTENTIAL TO CAUSE SAFETY HAZARDS UNDER THE MANAGEMENT RESPONSIBILITY OF THE MINISTRY OF SCIENCE AND TECHNOLOGY

Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;

Pursuant to Decree No. 28/2008/NĐ-CP dated March 14, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Law on Product Quality and Goods;

The Minister of Science and Technology hereby issues guidelines on the procedures for registration of new products with potential to cause safety hazards under the management responsibility of the Ministry of Science and Technology as follows:

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Article 1. This Circular guides the procedures for registration of new products with potential to cause safety hazards under the management responsibility of the Ministry of Science and Technology, including the units specified in Point p, Clause 2, Article 32 of Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing the implementation of certain provisions of the Law on Product Quality, including the procedures for registration, examination of registration files, approval of new product registration, and responsibilities of related parties.

Article 2. This Circular applies to organizations and individuals (hereinafter referred to as enterprises) producing or importing new products with potential to cause safety hazards under the management responsibility of the Ministry of Science and Technology, and state management agencies regarding product quality under the Ministry of Science and Technology.

Article 3. For new products within specialized fields already regulated by separate legal regulations, they shall be implemented according to those legal regulations.

Article 2. Explanation of terms

Strategic multi-purpose hydropower plant

1. Products, goods with potential to cause safety hazards are products, goods that, under conditions of transportation, storage, preservation, reasonable and proper use, still pose a risk of harm to people, animals, plants, property, and the environment.

2. New products with potential to cause safety hazards (hereinafter referred to as new products) include:

a) Products, goods being introduced for the first time into use and consumption in Vietnam with potential to cause safety hazards under the management responsibility of the Ministry of Science and Technology, or

b) Products, goods listed in the Catalogue of Products, Goods with Potential to Cause Safety Hazards under the Management Responsibility of the Ministry of Science and Technology issued together with Circular No. 01/2009/TT-BKHCN dated March 20, 2009 of the Minister of Science and Technology, which have changed their characteristics due to changes in structure, material quality, or manufacturing technology.

3. Examination of new product registration file is the process of reviewing the enterprise's technical documents to determine the completeness and validity of the registration file, the scientific and veracity of evidence proving that the new product meets quality, safety, health, and environmental standards.

Article 3. General Principles

1. Enterprises producing or importing new products for circulation on the market must provide scientific evidence proving that such products meet the intended use and consumption purposes, ensuring safety for people, animals, plants, property, and the environment, and commit to the authenticity of such evidence; they are responsible for the quality and safety of the products for people, animals, plants, property, and the environment.

2. The agency receiving new product registrations organizes the examination of the enterprise's registration files, reports the examination results to the Ministry of Science and Technology to issue a notice approving the new product registration and assign a registration number to the enterprise.

3. During the examination process, depending on the specific characteristics of the type of new product, if necessary, the agency receiving registrations as stipulated in Article 9 of Chapter III of this Circular may organize on-site inspections at domestic production enterprises (for domestically produced new products) or may request enterprises to seek opinions from relevant experts or require pilot use of the new product before registration approval.

4. After being approved for registration and put into circulation on the market, if there are no complaints or reflections about risks causing safety hazards to people, animals, plants, property, and the environment due to the use and consumption of the new product within twelve months, the product will be considered a regular product and managed according to the laws on product quality.

Article 4. Conditions for enterprises to produce and import new products for circulation on the market

1. Have conducted research and testing to prove that the new product meets quality requirements for its intended use, consumption, and ensures safety for people, animals, plants, property, and the environment.

2. Does not violate laws on product quality, goods; intellectual property rights.

3. Registers and obtains approval from the Ministry of Science and Technology for the registration of new products.

Chapter II
PROCEDURE, REGISTRATION PROCEDURES, REVIEW OF APPLICATIONS AND ANNOUNCEMENT OF APPROVAL FOR NEW PRODUCT REGISTRATION

Article 5. Application for registration of new products

1. Enterprises producing and importing shall prepare the application for registration and submit it to the receiving authority in accordance with Article 9 of Chapter III of this Circular. The application includes:

a) Registration form in accordance with the model prescribed in Appendix I attached to this Circular;

b) Technical dossier of the new product:

- Trade name of the product; code, model, type; product label;

- Description of the new product accompanied by technical documents (features, raw materials, specific components or formula of the product, design drawings, production technology, testing methods, performance testing procedures,...);

- Standards announced applicable to the new product accompanied by their representation (on the product label; packaging; accompanying documents of the product, goods);

Instructions for installation, operation, use, transportation, storage;

- Information on warnings about the potential danger of the product, goods, and preventive measures;

- Reports on the results of testing and evaluation by foreign conformity assessment organizations with sufficient capacity designated by competent state authorities in Vietnam or domestic conformity assessment organizations registered in the relevant field according to the law for quality, safety, health, and environmental criteria of the new product.

c) Description of the plan and quality control measures during production (for enterprises producing new products);

d) Commitment not to infringe upon intellectual property rights regarding trademarks, industrial designs, patents, or utility models;

e) Other related technical documents (if any).

2. For imported new products that have been registered by the competent authority of the exporting country, enterprises shall submit a certified copy of the notification of approval along with the registration form in accordance with the model prescribed in Appendix I attached to this Circular.

Article 6. Review of registration applications

1. After receiving complete and valid applications, the receiving authority shall organize the review of the registration applications of enterprises producing and importing new products. The time for reviewing the registration application for new products depends on the type of product but shall not exceed twenty working days at most.

In cases where the new product has complex features requiring an extension of the review period beyond twenty working days, the receiving authority must notify the enterprise in writing and specify the reasons.

2. The receiving authority for new product registrations shall be responsible for reporting the review results along with recommendations to the Ministry of Science and Technology.

Article 7. Notification of Registration Approval

Based on the report of the examination results and recommendations of the agency receiving new product registration, if the requirements are met, the Ministry of Science and Technology shall notify in writing the approval of the new product registration and issue a registration number for the new product to the enterprise according to the model prescribed in Appendix II attached to this Circular. In case of refusal to approve the registration, the Ministry of Science and Technology shall notify in writing with clear reasons.

Chapter III
RESPONSIBILITIES OF THE ENTERPRISE AND MANAGEMENT AUTHORITY

Article 8. Responsibilities of Enterprises

The enterprise that has been approved for new product registration shall be responsible for:

1. Adhering to the regulations on production and business of new products as stipulated by law.

2. Being responsible for the quality and ensuring the safety of new products during production, importation, and circulation in the market.

3. Compensating for damages according to the provisions of the law on product and commodity quality for new products that have been approved for registration, if they cause damage to people, animals, plants, property, or the environment during reasonable and intended use.

4. Marking the issued registration number on the product label within the validity period of the registration approval document.

5. Publicly disclosing information about the production and importation of new products on the enterprise's website (if available) and related documents of the enterprise.

6. When receiving information reflecting risks causing harm to people, animals, plants, property, or the environment due to the use or consumption of new products, the producing or importing enterprise must immediately stop supplying such products; conduct research and implement appropriate remedial measures, and report to the Ministry of Science and Technology.

7. Accepting inspections and audits by state agencies authorized to oversee the production and business activities of new products. If there are violations, depending on the nature and severity of the violation, they will be handled according to the provisions of the law.

Article 9. Agency Receiving New Product Registrations

The General Department of Standardization, Metrology, and Quality Control is the lead agency responsible for receiving registration files, processing, and organizing the examination of registration files for new products under the management of the Ministry of Science and Technology.

Article 10. Responsibilities of the Agency Receiving New Product Registrations

1. Implementing this Circular.

2. Monitoring and compiling the situation of new products that have been registered. Reporting to the Ministry of Science and Technology every six months.

3. Publicly announcing on its website the list of new products that have been approved for registration.

4. Organizing inspections, audits, and recommending measures to handle violations of the law against enterprises producing or importing new products according to this Circular and other current relevant regulations.

Chapter IV
IMPLEMENTATION

Article 11. Effective Date

This Circular takes effect 45 days from the date of issuance.

Article 12. Implementation Organization

During implementation, if there are difficulties, relevant agencies, organizations, and individuals should promptly reflect them to the Ministry of Science and Technology for consideration and resolution./.

 

ANNEX I

SAMPLE NEW PRODUCT REGISTRATION FORM FOR PRODUCTS PRODUCED IN THE COUNTRY/IMPORTED WITH POTENTIAL TO CAUSE SAFETY RISKS
(Issued together with Circular No. 22/2009/TT-BKHCN dated September 30, 2009, of the Minister of Science and Technology)

 

REGISTRATION FORM

NEW PRODUCT PRODUCED IN THE COUNTRY/IMPORTED
WITH POTENTIAL TO CAUSE SAFETY RISKS
(register the type of product)

Respectfully submitted to: ...(name of the agency receiving the registration file)

1. Name of Enterprise: … 

belonging to …(name of the managing unit if any)..........................

2. Contact Address: …

Telephone: …Fax: …Email:…

3. Business Registration Certificate/Investment License No. …Issuing Authority: …issued on …at …

4. After studying the provisions of Circular No. 22/2009/TT-BKHCN dated September 30, 2009, of the Minister of Science and Technology guiding the procedures and formalities for registering new products with potential to cause safety risks under the responsibility of the Ministry of Science and Technology, we hereby register …(trade name of the product, goods) for the first time being produced/imported to be put into circulation in the market.

(Specifically for imported products, please specify: the product, goods supplied by …  (name of manufacturer/supplier and country of manufacture).

5. Attached documents (as specified at Article 5 Chapter II of the Circular):

-

-

We commit to the authenticity of the provided documentation and scientific evidence and bear full responsibility for the quality, safety, health, and environmental impact of the registered products and goods./.

 

 

ANNEX II

SAMPLE NOTICE OF APPROVAL FOR REGISTRATION OF NEW DOMESTICALLY PRODUCED/IMPORTED PRODUCTS WITH POTENTIAL TO CAUSE SAFETY RISKS
(Issued together with Circular No. 22/2009/TT-BKHCN dated September 30, 2009, of the Minister of Science and Technology)

 

NOTICE

Approval of registration for new product
domestically produced/imported with potential to cause safety risks

Based on the application for registration of new domestically produced/imported products with potential to cause safety risks dated … day of … month of … year submitted by … (name of enterprise) and the report on the examination results of the registration dossier of … (name of the registration receiving agency), the Ministry of Science and Technology hereby notifies:

1. Approval of registration for … (trade name of the product, goods) of … (name of the enterprise, contact address).

Registration code: … (name of the registration code)  

2. .......... (name of enterprise) shall be responsible for the quality and ensure the safety of … (trade name of the product, goods) during production, importation, and circulation in the market.   

 

 

Note: This notice is not a Quality Certificate for the product, goods.