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Circular No. 03/2001/tt-Byt: Guide To Business Equipment, Medical Equipment

Original Language Title: Thông tư 03/2001/TT-BYT: Hướng dẫn kinh doanh trang thiết bị, dụng cụ y tế

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CIRCULAR Guide to business equipment, medical instruments _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to Decree No. 11/1999/ND-CP dated 3/3/1999 of the Government "about the forbidden goods circulation, commercial services banned; Goods, trade service limiting business, business conditions ", the Ministry of health guide to business equipment, medical equipment as specified in section I, category 3 attached to Decree No. 11/1999/ND-CP dated 3/3/1999 as follows: Chapter 1: GENERAL PROVISIONS article 1. Equipment, medical instruments, including all technical equipment, instruments, specialized transportation, medical supplies are used to serve the preventive activity, and healing in the medical industry.
Article 2. Business equipment, medical instruments, is a type of conditional trading.
Article 3. The base business equipment, medical instruments are only active when there are enough conditions under the provisions of this circular and only be trading equipment, medical instruments were Ministry of health license.
Chapter 2: BUSINESS CONDITIONS equipment, medical TOOLS, article 4. Business conditions of the equipment, medical equipment for businesses: a. BUSINESSES PURCHASED: 1. Personnel: a. the person responsible of the technique must be a graduate of a technical system or University of medicine, pharmacy and have certificates of one or more specialized training equipment medical instruments, due to the technical training of medical equipment, or foreign equivalent certification level.
b. has a team of engineers, technical personnel qualified installation instructions, warranty, maintenance equipment and medical instruments that businesses are trading.
c. The person mentioned above must have enough health and not being prejudice criminal liability, are not criminal in prison or be deprived of the rights court practice.
2. On the basis of technical material: a. Must have an Office, warehouse, suitable to preserve the good equipment, medical instruments.
b. Must have adequate tools, equipment and techniques to ensure implementation is the work of installation, maintenance equipment and medical instruments.
c. Must have adequate means of extinguishing the fire and ensure the safety of the environment.
3. About the goods: business is business equipment, medical instruments were Ministry of health license.
B. for the MANUFACTURING ENTERPRISE: 1. Personnel: a. the person responsible of the technique must be a graduate of a technical system or University of medicine, pharmacy and have certificates of one or more specialized training equipment, medical equipment due to the technical training of medical equipment grant , or equivalent foreign certificate level.
b. has a team of staff, technical workers to meet production requirements for items produced by enterprises.
c. The person mentioned above must have enough health and not being prejudice criminal liability, are not criminal in prison or be deprived of the rights court practice.
2. On the basis of technical material: a. must have an area of production conformity requirements for the item the production business.
b. Must have enough equipment for production and testing equipment, product quality consistent with business production items.
c. Must have adequate means for the Fire Department, fire, labor protection means and ensuring environmental safety.
3. About the goods: products manufactured by enterprises are only allowed to circulate on the market after it has been granted a license to the Ministry of health.
Article 5. Business conditions of the equipment, medical equipment for the individual business households: 1. Personnel: a. the person responsible of the technique must have graduated from high school in the secondary school: medical engineering, Pharmaceutical Engineering School, or graduate of the school of technical medical equipment. Qualified personnel technical high school in other disciplines must have certificates of one or more specialized training equipment, medical equipment due to the technical training of medical equipment, or foreign equivalent certification level.
b. have enough health and not being prejudice criminal liability, are not criminal in prison or be deprived of the rights court practice.
2. On the basis of technical material: a. must have suitable container, store enough conditions to preserve the good equipment, medical instruments.
b. Must have adequate technical tools needed for maintenance and repair of equipment and medical instruments.
c. Must have adequate means of extinguishing the fire and ensure the safety of the environment.
3. About the goods: individual business households was interior equipment business serving hospitals, tooling, medical supplies were Ministry of health license.
Chapter 3: JURISDICTION and PROCEDURE for CERTIFICATION of QUALIFIED BUSINESS equipment, medical instruments article 6. The certification authority eligible business equipment, medical instruments: Department of health province of central cities, (hereinafter referred to as the Department) is assigned, the certification of qualified business equipment, medical instruments.
Article 7. Records suggest the certification of qualified business equipment, medical instruments for business: 1. Application eligibility certification of business equipment, medical equipment (model 1).
2. business registration certificate (copies are valid).
3. Profile of the person in charge of the engineering business.
4. Profile of the technical staff working on installation, warranty.
5. documents of organise, treasure, technical equipment.
Article 8. Records suggest the certification of qualified business equipment, medical instruments for personal, individual business households: 1. Application eligibility certification of business equipment, medical equipment (model 2).
2. business registration certificate (copies are valid).
3. Profile of the person responsible for technical equipment, medical instruments.
4. The material about the treasure, technical equipment.
Article 9. Within 15 working days of receipt of a valid application, based on the results of the evaluation of the business conditions specified in this circular, the Department of health will issue the certificate of qualified business equipment, medical instruments, if not level must clearly state the reason in writing.
Article 10. The enterprise is certified eligible equipment business, medical instruments must submit a fee in accordance with the current law on fees and charges.
Chapter 4: test, inspection and HANDLING VIOLATION of article 11. Test, inspection 1. Service equipment-CTYT in collaboration with the Service, the relevant Bureau and Department of health inspectors inspect, inspect the implementation of the provisions of the law on equipment, medical instruments and the provisions of this circular on nationwide.
2. the Department of health inspect, inspect the implementation of the provisions of the law on equipment, medical instruments and the provisions of this circular on geographical scope.
3. The inspection, the inspection is conducted periodically or irregularly.
4. The base business equipment, medical equipment needs and create favorable conditions for the inspection, inspectors at its base.
Article 12. Handle violation: Home base business equipment, medical instruments in violation of the provisions of this circular and the provisions of the relevant laws according to the nature and extent of the violation will be sanctioning administrative violations, or prejudice the criminal responsibility, if the damage to compensation under the provisions of the law.
Chapter 5:

TERMS OF IMPLEMENTATION of article 13. This circular effect after 15 days from the date of signing and replacing circular No. 14/1998/TT-BYT on November 17, 1998 on business activities in private medical equipment.
 
 
In the process, if there are difficulties and obstacles the unit, local reflection on the Ministry of health (Service equipment-CTYT) for review and resolution.