“Hello Lawyer, Can you tell me the conditions for trading medical chemicals under Vietnamese law? I would like to thank you very much for answering my questions.“. Thank you for sending us your question. The healthcare industry is developing not only in the world but also in Vietnam. Currently, there are many private hospitals and medical facilities. What are the conditions for trading in medical chemicals according to Vietnamese law? To be able to provide you with information about Conditions for trading in medical chemicals under Vietnamese law? Today, LSX Lawfirm will give you an article about “Conditions for trading in medical chemicals according to Vietnamese law”, as follows:
Legal grounds
Decree 113/2017/ND-CP guiding the Law on Chemicals
Conditions for trading in medical chemicals according to Vietnamese law?
Conditions for production and trading of chemicals in the pharmaceutical sector
Establishments producing and trading chemicals used in the pharmaceutical sector must have professional managers, physical and technical facilities, and personnel according to the provisions of the Law on Pharmacy and Decree No. 79/2006/ND-CP dated August 9, 2006, of the Government detailing the implementation of a number of articles of the Law on Pharmacy.
What does it take to produce chemicals, insecticidal and germicidal preparations for household and medical use?
Establishments manufacturing insecticidal and germicidal chemicals and preparations for household and medical use must fully satisfy the following conditions:
a) Firstly, The person directly managing the production activities has a university degree or higher in chemical major;
b) Secondly, Physical and technical facilities in the production facility must meet the requirements specified in Article 12 of the Law on Chemicals;
c) Thirdly, Having sufficient quality inspection equipment or an association contract with a unit capable of quality inspection to check the quality of goods;
d) Finally, Take measures to manage fire and explosion prevention and fighting, chemical incidents, waste treatment, and environmental protection according to the provisions of law.
Requirements when trading chemicals, insecticidal and germicidal preparations for household and medical use
An establishment trading in insecticidal and germicidal chemicals and preparations for household and medical use must fully satisfy the following conditions:
a) Firstly, The person in charge of chemical safety must have a high school degree or higher in chemicals, except for the case of trading in common insecticidal and germicidal preparations, including mosquito repellant incense, an insecticidal spray. insect repellent, insect repellant cream, electric mosquito repellant chemical sheet, electric mosquito repellent solution, chemically impregnated mosquito nets, and baits to kill cockroaches and flies;
b) Secondly, Physical and technical facilities in business establishments must meet the requirements as prescribed in Article 12 of the Law on Chemicals;
c) Thirdly, Take measures to manage fire and explosion prevention, chemical incidents, waste treatment, and environmental protection according to the provisions of law.
Conditions for production of chemicals used in medical equipment
Establishments producing chemicals used in medical equipment must fully satisfy the conditions specified in Clause 2 of this Article then.
Conditions for trading in chemicals used in medical equipment
Establishments trading in chemicals used in medical equipment must satisfy the conditions; for trading in medical equipment as prescribed by law then.
What are the requirements for factories and warehouses when trading in chemicals?
According to Article 4 of Decree 113/2017/ND-CP guiding the Law on Chemicals, the requirements for factories and warehouses need to:
Workshops must meet requirements according to national technical standards and regulations, suitable to the nature, scale, and technology of chemical production and storage.
Workshops and warehouses must have exits and exits. Emergency exits must clearly indicated by signs and lights; and be designed to facilitate escape, rescue, and rescue in case of an emergency.
The ventilation system of factories and warehouses must meet the regulations and standards on ventilation systems.
The lighting system complies with regulations to meet the requirements of chemical production and storage. Electrical equipment in workshops and warehouses containing flammable; and explosive chemicals must meet standards on fire and explosion prevention and control.
Workshop and chemical warehouse floors must be resistant to chemicals, loads, and non-slip, with good drainage and collection grooves.
In addition
Workshops and chemical warehouses must have a table of rules on chemical safety, have danger signs suitable to the level of danger of chemicals, and hang them in conspicuous places. Signs showing hazardous properties of chemicals must have the following information: Chemical identification code; graphic warning, word warning, and warning of danger. In case a chemical has many different hazardous properties, the warning picture must fully show those hazardous properties. In production areas with hazardous chemicals, there must be specific instructions on safe operation procedures in an easy-to-read and conspicuous position.
Workshops and warehouses must have a lightning protection system or be located in a safe area with lightning protection and be periodically checked in accordance with current regulations.
For outdoor tanks, it is necessary to build dikes or other technical measures to ensure that chemicals do not escape into the environment when a chemical incident occurs and take measures to prevent fire, explosion and lightning. Workshops and warehouses must fully meet the conditions on fire prevention and fighting, environmental protection, occupational safety, and hygiene in accordance with relevant laws.
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Related questions
To know whether medical equipment is required to apply for a license, the enterprise needs to check whether the imported goods are in Appendix I of Circular 30/2015/TT-BYT. If the items are listed in this Appendix I will need an import license to be able to import them.
Firstly, Decree 36/2016 on Management of medical equipment
Secondly, Decree No. 169/2018/ND-CP of the Government: Amending and supplementing a number of articles of the Government’s
Thirdly, Decree No. 36/2016/ND-CP dated May 15, 2016, on the management of medical equipment
Organizations entitled to announce applicable standards or register for the free sale of medical equipment include
a) Firstly, Vietnamese enterprises, cooperatives, and business households that are owners of medical equipment;
b) Secondly, Vietnamese enterprises, cooperatives, and business households with the function of trading in medical equipment are authorized by the owner of the medical equipment to register;
c) Thirdly, The representative office permanently residing in Vietnam of a foreign trader who is the owner of the medical equipment or authorized by the owner of the medical equipment.
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