Regular manufacturers need to have the certificate should be:
1, the company's business license, which is the most basic thing.
2, a variety of instrument testing and certification, we must know that everything has to be tested and certified in order to factory sales, such as exports to Europe and the European standard CE.
3, medical device license is a medical device business enterprises must have a document, without this certificate are not allowed to sell the country, if found out not only confiscate the instrument, the penalty is up to a few hundred thousand because of the hundreds and thousands, and tens of thousands of penalties.
National regulations in a class two is not required to record, and class three medical devices is the highest level of medical devices, but also must be strictly controlled medical devices, is implanted in the human body, used to support, maintain life, the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices, medical device license is for class three, so the impact of the certificate or not is very big! The medical device license is for the third category, so the influence of the certificate is very big.
Extended information:
According to the provisions of the regulations, the enterprise should set up with the scale of operation, business varieties of the technical training and after-sales service department/personnel or agreed to by the third party Provide technical support.
The person in charge of quality shall have a college degree or above in medical devices or related majors, or a state-recognized technical title of junior or above in related majors (related majors refer to mechanical, electronic, medical, pharmacy, bioengineering, chemistry, nursing, computer science, engineering, agriculture, medicine and pharmacy, etc., hereinafter referred to as the same).
The person in charge of quality should be familiar with the supervision and management of medical devices, rules and regulations and the management of medical devices and related knowledge and have a certain amount of practical experience.
The person in charge of the quality management organization shall have a bachelor degree or above in medical devices or related disciplines or a state-recognized technical title of intermediate or above in related disciplines, and have more than 2 years of experience in medical device-related work.
Baidu Encyclopedia-Medical Device Supervision and Administration Regulations