Medical device industry involves medicine, machinery, electronics, plastics and other industries. It is a high-tech industry with interdisciplinary, knowledge intensive and capital intensive. It is an industry with rapid development in modern society. It is also a strategic emerging industry supported by the state.
So how to register a medical device company in Shanghai? Next, Yu Shang Xiaobian will tell you something.
Medical devices can be divided into three categories according to their risk degree, and the processing conditions of different types of medical devices are also different. Today, I will focus on the registration of class II medical device companies.
First of all, the registration should have the conditions
1. It shall have a quality management organization or quality management personnel suitable for its business scope and scale, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state;
2. It shall have business and storage sites suitable for its business scope and scale;
3. If the storage conditions are suitable for the business scope and scale, and all the medical devices are entrusted to other medical device business enterprises for storage, the warehouse may not be set up;
4. Have a quality management system suitable for the medical devices;
5. Have the ability of professional guidance, technical training and after-sales service corresponding to the medical devices, or agree to provide technical support by relevant institutions.
Class II medical device company registration process is the same as the general company registration process, but there is an on-site inspection and filing process.
About the filing of class II medical devices. Class II medical devices refer to those with moderate risk, which need strict control and management to ensure their safety and effectiveness. According to the regulations of the measures for the supervision and administration of the operation of medical devices, those engaged in the operation of class II medical devices shall file with the local municipal food and drug administration, fill in the record form for the operation of class II medical devices, and submit the following information:
1. Copy of business license;
2. Copies of the identity certificate, educational background or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality;
3. Description of organization and department setting; description of business scope and operation mode;
4. A copy of the geographical location map, plan of the address of the business site and warehouse, the certificate of the property right of the house or the lease agreement (with the certificate of the property right of the house attached);
5. Catalogue of business facilities and equipment; catalogue of business quality management system, working procedures and other documents;
6. Other supporting materials.
The requirements for the area of the warehouse are different with the operation of medical devices. If the business is a disposable medical device enterprise for blood transfusion, infusion and injection, the warehouse area should not be less than 100 square meters (different regions have different policy requirements).
If the enterprise is engaged in three types of medical devices, it needs to apply for a medical device business license. The term of validity of the medical device business license is 5 years. If the term of validity needs to be extended, the renewal procedures shall be handled in accordance with the relevant laws and regulations on administrative license. If a registrant fails to apply for renewal of registration within the specified time limit; the mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration can not meet the new requirements; if the medical devices used for treating rare diseases and dealing with public health emergencies are not completed within the specified time limit, the renewal of registration will not be allowed.