Circular No. 07/2002/TT-BYT guides the registration for circulation of medical equipment products applicable to domestic production and trading enterprises as well as importers. It provides detailed regulations on the dossier, procedures, authority to issue circulation registration numbers, validity period of circulation registration numbers, inspection, supervision, and handling of violations.
적용 범위
Domestic medical equipment manufacturing enterprises, organizations and individuals importing medical equipment, Ministry of Health, Provincial Health Departments under central cities.
핵심 사항
- Domestic medical equipment manufacturing enterprises must be issued a circulation registration number by the Ministry of Health before they can circulate their products on the market.
- The dossier for registering the circulation of medical equipment products includes: Application form, Business Registration Certificate, Declaration of Product Quality Standards or Declaration of Compliance with Product Standards, Test results from at least three healthcare facilities, Test results of chemical, physical properties and safety testing (if applicable), Technical documentation, user manual, Product label.
- The authority to issue circulation registration numbers is managed by the Ministry of Health, with a processing time of fifteen working days from the date all required documents are received. The circulation registration number is valid for three years and must be renewed thirty days prior to expiration if the product continues to be marketed.
- If medical equipment does not meet quality requirements or if advertising information is false, the Ministry of Health will revoke the circulation registration number.
- Violations of this Circular and other relevant laws will result in administrative penalties or criminal prosecution.
🌐 이 문서의 사회적 영향
- Positive impact: Ensuring the quality of medical equipment products, enhancing user safety.
- Negative impact: Registration and inspection costs may increase for businesses.
❓ 자주 묻는 질문
What do businesses need to prepare to register for the circulation of medical equipment?
To register for circulation, businesses need to prepare an Application Form, Business Registration Certificate, Declaration of Product Quality Standards or Declaration of Compliance with Product Standards, Test results from at least three healthcare facilities, Test results of chemical, physical properties and safety testing (if applicable), Technical documentation, user manual, Product label.
What is the validity period of the circulation registration number?
The circulation registration number is valid for three years from the date of issuance. Thirty days before expiration, if the business continues to market the product, it must renew the registration.
What happens if medical equipment does not meet quality requirements?
The Ministry of Health will revoke the circulation registration number if medical equipment that has been registered for circulation fails to meet quality requirements during use or if there is false advertising.
How will violations of this Circular be penalized?
Depending on the nature and severity of the violation, violators may face administrative penalties or criminal prosecution, and must compensate for any damages caused.
What is the deadline for businesses to pay the registration fee for medical equipment?
This Circular does not specify a specific deadline for paying the registration fee for medical equipment, only stating that the registration entity must pay the fee according to current regulations.
전문
CIRCULAR
Guidance on registering for circulation of medical equipment products
Pursuant to the Law on Health Care for the People dated July 11, 1989;
Based on the proposal of the Ministry of Health at Official Letter No. 7901/YT-QLTP dated September 20, 2002;
Pursuant to Circular No. 07/TTLB dated July 1, 1996 issued jointly by the Ministry of Health and the Ministry of Science, Technology, and Environment guiding the implementation of Decree No. 86/CP;
Pursuant to the Ordinance on Quality of Goods dated December 24, 1999;
Pursuant to Decision Nos. 2424 and 2425/2000/QĐ-BKHCNMT dated December 12, 2000 of the Minister of Science, Technology, and Environment regarding the issuance of temporary regulations on announcing goods that meet standards and temporary regulations on announcing quality standards for goods;
The Ministry of Health provides guidance on registering for circulation of medical equipment products as follows,
This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.
1.1. Medical equipment produced in Vietnam must be registered with the Ministry of Health to obtain a registration number before being circulated in the market.
1.2. This Circular stipulates the procedures, documents, and authority for issuing registration numbers for medical equipment produced domestically.
1.3. For imported medical equipment, compliance shall be in accordance with Decision No. 46/2001/QĐ-TTg dated April 4, 2001 of the Prime Minister and other regulatory documents guiding the implementation of said Decision.
II. REGULATIONS ON THE DOCUMENTATION FOR REGISTERING FOR CIRCULATION OF MEDICAL EQUIPMENT PRODUCTS
The registration documentation must be compiled into one set, bound, and include the following contents arranged in the following order:
2.1. Application for registration of medical equipment product circulation.
2.2. Business registration certificate indicating the production function of medical equipment (certified copy).
2.3. Quality standard announcement or announcement of goods meeting standards.
2.4. Test results from at least three healthcare facilities in Vietnam (the Ministry of Health designates the healthcare facilities for testing according to each type of product).
2.5. Testing results of chemical and physical properties and safety certification by competent authorities (for products requiring testing and certification).
2.6. Technical documents and user guides.
2.7. Product label: In accordance with the Labeling Regulations for Domestic Circulation and Exported and Imported Goods issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister and Circular No. 34/1999/TT-BTM dated December 15, 1999 of the Ministry of Trade.
III. AUTHORITY AND PROCEDURES FOR ISSUING REGISTRATION NUMBERS FOR CIRCULATION OF MEDICAL EQUIPMENT PRODUCTS
3.1. The application for registration of medical equipment products must be submitted to the Ministry of Health (Department of Medical Equipment and Health Facilities).
3.2. The Ministry of Health will review and issue the registration number for medical equipment products within fifteen working days from the date of receipt of complete documentation as prescribed. If not issued, a written response stating the reasons will be provided.
3.3. The registration number is valid for three years from the date of issuance. Thirty days prior to expiration, if continued business and production of registered products is intended, the entity must apply for renewal. During the period of circulation, if the manufacturer makes changes to the product's design or technical specifications, they must report this in writing to the Ministry of Health.
3.4. Entities applying for registration of medical equipment must pay the registration fee for medical equipment according to current regulations.
IV. INSPECTION, AUDIT AND VIOLATION HANDLING
4.1. Organizations and individuals producing and trading in medical equipment are responsible for the quality of their products and are subject to inspection and supervision by the Ministry of Health, provincial and municipal health departments.
4.2. The Ministry of Health will issue a decision to revoke the registration number in cases where medical equipment with a registration number does not meet quality requirements during use, does not match the registered documentation, false advertising, or other fraudulent acts concerning product quality.
4.3. Organizations and individuals violating the provisions of this Circular and other relevant laws will be administratively punished or criminally prosecuted depending on the nature and severity of the violation. If damage is caused, compensation must be made in accordance with the law.
V. IMPLEMENTATION PROVISIONS
5.1. This Circular takes effect fifteen days from the date of issuance. Previous regulations contrary to this Circular are hereby abolished.
5.2. The Department of Medical Equipment and Health Facilities, the Inspectorate of the Ministry of Health, provincial and municipal health departments, organizations, and individuals producing and trading in medical equipment are responsible for implementing the provisions of this Circular./.
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