"Supervision and Administration of Medical Devices Regulations" (State Council Decree No. 650) Article 11: apply for registration of Class II medical device products, the applicant for registration shall be the location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the food and drug supervision and management department to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit the registration application information to the State Council Food and Drug Administration. To China's exports of Class II, Class III medical devices overseas manufacturers, should be set up by its representative body in China or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the application for registration information and registration of the applicant's country (region) competent authorities to authorize the sale of the medical devices on the market documents. Class II, Class III medical device product registration application information in the product inspection report shall be a medical device inspection agency issued the inspection report; clinical evaluation information shall include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from clinical trials of medical devices.
Four, the acceptance of institutions
State Food and Drug Administration Medical Device Technical Review Center
Five, the decision-making body
State Food and Drug Administration
Six, the number of approvals
No number of limitations
Seven, the conditions of work
Applicants should be overseas manufacturers
The applicant shall be an overseas manufacturer, and the medical device has been approved for marketing in the country (region) where the applicant is registered or where the manufacturing address is located.
VIII, application materials
(A) the list of application materials
Table 1: medical device registration information requirements and instructions
Registration information should be submitted information catalog, including the declaration of information on the first level and second level of title. Each secondary title corresponding to the information should be prepared separately page number.
Overseas applicants should submit:
1. overseas applicants registered or production address in the country (region) where the competent medical device authority issued by the product is permitted to market and sale of documents, documents certifying the qualifications of enterprises.
2. Foreign applicants registered or production address in the country (region) is not the product as a medical device management, the applicant needs to provide relevant documents, including registration or production address in the country (region) to allow the product on the market and sale of documents.
3. Overseas applicants in China to designate the agent's power of attorney, the agent's statement of commitment and a copy of the business license or a copy of the agency's registration certificate.