Legal analysis: engaged in the production of medical devices and business activities require different conditions, but all need to have the appropriate site, personnel, quality management system.
Legal basis: "Regulations for the Supervision and Administration of Medical Devices"
Article 30 To engage in the production of medical devices, shall have the following conditions:
(a) with the production of medical devices appropriate
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Production sites, environmental conditions, production equipment, and professional and technical personnel ;
(ii) have the ability to produce medical devices quality inspection organization or full-time inspectors and inspection equipment;
(iii) have to ensure that the quality of medical devices management system;
(iv) with the production of medical devices compatible with after-sales service such as hui capacity;
(v) in line with the requirements of the product development, production process document regulations
The third part of the medical device.
Article 32 engaged in the production of Class II, Class III medical devices, should be potato buckets to the seat of the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department to apply for production licenses and submit their compliance with the conditions of the provisions of Article 30 of the Ordinance, as well as the relevant information on the production of medical devices and the certificate of registration.
To accept the application for production authorization of drug supervision and management departments should be slag hand answer when the application information for review, in accordance with the State Council drug supervision and management departments to develop the requirements of the quality management standard for the production of medical devices yamdo for verification, and from the date of acceptance of the application within 20 working days, such as Hui to make a decision. To meet the prescribed conditions, permission is granted and issued to the production of medical devices license; do not meet the prescribed conditions, not licensed and a written explanation of the reasons.
Medical device manufacturing license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.
Article 40 to engage in medical device business activities, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Article 42 is engaged in the third class of medical equipment business, the business enterprise shall be located in the municipal people's government responsible for drug supervision and management of the department responsible for applying for business licenses and submit to meet the conditions of Article 40 of the Ordinance, the relevant information.
Acceptance of applications for operating licenses responsible for drug supervision and management of the residual answer to the department shall review the application information, if necessary, the organization to verify, and accept the application from the date of 20 working days to make a decision. To meet the prescribed conditions, permit and issue a medical device license; do not meet the prescribed conditions, not permit and explain the reasons in writing.
Medical device license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.