In China, the medical device registration main acceptance of the agency is the SFDA (State Food and Drug Administration), the State Food and Drug Administration is the State Council's comprehensive supervision of food, health care, cosmetic safety management and supervision of pharmaceuticals directly under the agency. management and in charge of drug supervision directly under the State Council.
The SFDA is responsible for drafting laws and administrative regulations on the management of medical devices and overseeing their implementation; it is also responsible for the registration and supervision of medical device products; it drafts relevant national standards, formulates and revises industry standards for medical device products, and produces and supervises the implementation of quality management standards.
August 9, 2004, the SFDA (State Food and Drug Administration) promulgated Order No. 16, the medical device registration management methods, which provides for some of the relevant requirements of the medical device enterprise product registration and the registration number of the format of the explanation. It mainly includes the following six points:
I. If the products produced by the medical device enterprises are sold and used in China, they must be registered as medical devices, otherwise the medical devices which are not authorized to be registered shall not be sold or used.
Second, the state of medical devices to implement classification and registration management.
A class of medical device registration acceptance unit is the municipal (food) drug supervision and management agencies, review and approval of medical devices issued after the registration certificate.
The second class of medical devices registration unit is the province, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments, through the examination and approval issued after the medical device registration certificate.
The registration of Class III medical devices is accepted by the State Food and Drug Administration, the approval of the certificate of registration of medical devices.
In addition, the provisions of the overseas medical device registration and Hong Kong, Macao and Taiwan medical device registration management, mainly by the State Food and Drug Administration to review and approve the issuance of a certificate of registration of medical devices. Taiwan, Hong Kong, Macao and the registration of medical devices, in addition to the provisions of these measures, with reference to overseas medical devices.
Four, provides a medical device registration certificate is valid for four years.
V. Enterprises applying for registration of medical devices, should have the corresponding product standards, you can use national standards, industry standards or the development of registered product standards, but the registered product standards shall not be lower than national standards or industry standards. Registered product standards should be based on the State Food and Drug Administration standard management requirements for the preparation of medical devices.
Sixth, the medical device registration certificate format explained.
In accordance with the SFDA (State Food and Drug Administration) promulgated Order No. 16, the medical device registration certificate printed by the State Food and Drug Administration, the corresponding content by the approval of the registration of (food) drug supervision and management departments to fill in.
The format of the registration number is required as follows:
×(×)1 (food) Drug Supervision and Inspection of mechanical (×2) word ××××3 No. ×4 ××5 ××××6. Where:
×1 for the registration and approval of the department of the location of the abbreviation:
The third class of medical devices within the territory of medical devices, medical devices outside the territory, as well as Taiwan, Hong Kong, Macao and medical devices for the word "country";
International second class of medical devices for the registration and approval of the department of the province, autonomous region, Municipalities directly under the Central Municipality of the abbreviation;
The first class of medical devices in the territory of the registration and approval department of the province, autonomous region, municipality directly under the Central Municipality of the abbreviation of the municipal administrative region plus the abbreviation of the municipal administrative region of the district, for × × 1
(without the corresponding municipal administrative region of the municipality, only for the abbreviation of the province, autonomous region, municipality directly under the Central Municipality of the abbreviation);
×2 for the registration of the form (quasi, into the permit, license):
The word "permit" applies to medical devices within the territory;
"In" applies to medical devices outside the territory;
"Permit" applies to medical devices in Taiwan, Hong Kong and Macao;
"Permit" applies to medical devices in Taiwan, Hong Kong, Macau;
××××3 is the year of approval for registration;
×4 is the product management category;
××5 is the product variety code;
××××6 is the registration number.
The implementation of these measures is aimed at strengthening the supervision of the sale and use of medical devices, standardizing the process of medical device registration and promoting the healthy development of the medical device industry.
Aojida medical device consulting organization is the only medical device regulatory consulting organization in China that focuses on the medical device field, headquartered in Guangzhou, with six subsidiaries in Beijing, Shanghai, Suzhou, Shenzhen, Jinan, and the United States.