Chapter 1 General Provisions Article 1 In order to standardize the registration management of medical devices and ensure the safety and effectiveness of medical devices, these Measures are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices". Article 2 All medical devices sold and used within the territory of the People's Republic of China must apply for registration in accordance with the provisions of these Measures. Medical devices that have not been approved for registration shall not be sold or used. Article 3 Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices intended for sale and use in accordance with legal procedures to decide whether to agree to their sale and use. Article 4: The state implements classified registration management of medical devices.
Domestic Class I medical devices shall be reviewed by the districted municipal (food) drug regulatory agency, and a medical device registration certificate will be issued upon approval.
Domestic Class II medical devices shall be reviewed by the (food) drug regulatory authorities of the provinces, autonomous regions, and municipalities directly under the Central Government, and a medical device registration certificate will be issued upon approval.
Domestic Class III medical devices will be reviewed by the State Food and Drug Administration, and a medical device registration certificate will be issued after approval.
Overseas medical devices are reviewed by the State Food and Drug Administration, and a medical device registration certificate is issued after approval.
Registration of medical devices in Taiwan, Hong Kong and Macao shall be handled with reference to overseas medical devices, unless otherwise provided in these Measures.
The medical device registration certificate is valid for 4 years. Article 5 The medical device registration certificate shall be uniformly printed by the State Food and Drug Administration, and the corresponding content shall be filled in by the (food) and drug regulatory department that approved the registration.
The registration number is organized as follows:
× (×) 1 (Food) Drug Supervision Equipment (× 2) ××××3 No. No. ××6. Among them:
×1 is the abbreviation of the location of the registration and approval department:
Domestic Class III medical devices, overseas medical devices, and medical devices in Taiwan, Hong Kong, and Macao are "national" word;
The abbreviation of the province, autonomous region, or municipality where the registration and approval department is located for the second-class medical devices in the country;
The first-class medical device in the country is the province or autonomous region where the registration and approval department is located. , the abbreviation of the municipality plus the abbreviation of the municipal administrative region divided into districts is ××1 (if there is no corresponding municipal administrative region divided into districts, it is only the abbreviation of the province, autonomous region, or municipality directly under the Central Government);
× 2 is the registration form (quasi, advanced, approved):
The word "quasi" applies to domestic medical devices;
The word "jin" applies to overseas medical devices;
The word "Xu" applies to medical devices in Taiwan, Hong Kong, and Macau;
××××3 is the year of registration approval;
×4 is the product management category;
××5 is the product variety code;
××××6 is the registration serial number.
The medical device registration certificate is accompanied by the "Medical Device Registration Form" (see Attachment 1 of these Measures), which is used simultaneously with the medical device registration certificate. Article 6 A manufacturing enterprise shall submit an application for medical device registration, assume corresponding legal obligations, and hold a medical device registration certificate after the application is approved.
Personnel handling medical device registration applications should be entrusted by the production enterprise, have corresponding professional knowledge, and be familiar with the laws, regulations, rules and technical requirements for medical device registration management.
When applying for registration of overseas medical devices, the overseas production enterprise shall designate an agency in China as its agent, and the agent shall bear corresponding legal responsibilities; and, the overseas production enterprise shall entrust a person with corresponding qualifications in China to Legal entities or entrust their institutions in China to provide after-sales services for medical devices. Article 7 Medical devices applying for registration shall have applicable product standards. National standards, industry standards, or registered product standards may be formulated, but registered product standards shall not be lower than national standards or industry standards.
Registered product standards shall be prepared in accordance with the medical device standard management requirements stipulated by the State Food and Drug Administration. Article 8 To apply for registration of Class II and Class III medical devices, manufacturing enterprises shall comply with the production conditions or relevant quality system requirements prescribed by the State Food and Drug Administration.
?Chapter 2 Medical Device Registration and Testing Article 9 Class 2 and Class 3 medical devices shall be registered and tested by a medical device testing agency recognized by the State Food and Drug Administration in conjunction with the General Administration of Quality Supervision, Inspection and Quarantine. After testing, the products meet the applicable requirements After meeting the standards, it can be used in clinical trials or apply for registration.
The catalog of medical device testing institutions (hereinafter referred to as medical device testing institutions) approved by the State Food and Drug Administration in conjunction with the State Administration of Quality Supervision, Inspection and Quarantine will be released separately. Article 10 Medical device testing institutions shall be within the testing scope recognized by the State Food and Drug Administration and the State Administration of Quality Supervision, Inspection and Quarantine, and based on the applicable product standards declared by the manufacturing enterprise (including applicable national standards, industry standards or those formulated by the manufacturing enterprise) Registered product standards) conduct registration testing on declared products and issue test reports.
Medical devices that have not yet been included in the inspection scope of various medical device testing agencies shall be tested by the testing units with the ability to undertake inspections designated by the corresponding registration and approval departments.
The registration and testing of overseas medical devices shall comply with the "Regulations on Registration and Testing of Overseas Medical Devices". Article 11 The products tested in the same registration unit should be typical products that can represent the safety and effectiveness of other products in this registration unit.