The State Administration of Medicine is the medical device administrative supervision and management department authorized by the State Council.
The whole country adopts a unified medical device product registration certificate and registration number. Article 3 A medical device product means: any instrument, apparatus, appliance, material or other article used in the human body for the following purposes, whether used alone or in combination, including the software required for its use, which are:
--diagnosis, prevention, guardianship, treatment or alleviation of disease;
--Diagnosis, guardianship, treatment, mitigation, or compensation of injury or disability;
--Study, substitution, or regulation of anatomical or physiological processes;
-. -Pregnancy control.
Their primary intended effect on the human body surface and in vivo is not obtained by pharmacological, immunological or metabolic means, but these means may be involved and play a supporting role. Article IV medical device products are divided into three categories:
The first category refers to the routine management is sufficient to ensure the safety and efficacy;
The second category refers to the mechanism of the product has been internationally and domestically recognized, technologically mature, safety and efficacy must be controlled;
The third category refers to the implantation of the human body, or used for life support, or the complexity of the technical structure of the human body may be Potentially dangerous, safety and effectiveness must be strictly controlled.
The Classification Catalog of Medical Devices is issued and regularly adjusted by the State Administration of Medicine. Article 5 The State Administration of Pharmaceutical Affairs is responsible for the registration of medical device products throughout the country, and directly accepts the registration review of Class III medical device products produced by domestic enterprises and medical device products produced by overseas enterprises.
The State Administration of Medicine may entrust the provincial, autonomous regions and municipalities directly under the Central Administration of Medicine or the provincial, autonomous regions and municipalities directly under the Central Government to determine the supervision and management of medical device administration (hereinafter referred to as the provincial medical device management department) on the jurisdiction of the enterprises produced by the first and second class of medical device products for registration or review.
The provincial medical device administration department that has been entrusted shall summarize the registered medical device products at the end of each month and report to the State Administration of Medicine. Article 6 The products registered within the prescribed scope can be sold throughout the country without repeated registration. Article VII of the domestic enterprises to produce the first class of medical device products at the provincial level of medical device management department for registration of quasi-production.
The state of the second and third class of medical device products produced by domestic enterprises to implement a phased registration review. The first stage for trial production registration, mainly to review the safety and effectiveness of the product. The second stage of quasi-production registration, the main review of the enterprise quality assurance capabilities.
The quasi-production registration of Class I medical device products should provide:
(1) product standards and preparation of instructions;
(2) product performance self-test report (factory inspection report);
(3) product instructions.
Trial production of Class II medical device products should be submitted to the registration:
(1) trial report;
(2) product standards and preparation of instructions;
(3) self-test report of product performance (factory inspection report);
(4) provincial medical device management department recognized by the medical device quality inspection agency issued by the product type test report;
(5) product clinical research or clinical verification report;
(6) product instructions.
The trial production registration of Class III medical device products shall be submitted:
(1) product technical reports;
(2) product standards and compilation of instructions;
(3) self-test report of the product performance (factory inspection report);
(4) product form test report issued by the State Administration of Medicine-approved quality inspection center for medical devices;
(5) product clinical research or clinical validation report;
(6) product instructions. /p>
(5) product clinical research or clinical verification report;
(6) product instructions.
Trial production registration is valid for two years, and the producer can apply for quasi-production registration starting from the seventh month after the trial production registration. Quasi-production registration should be submitted:
(1) trial production registration certificate;
(2) trial production period, the product and production process improvement or change report;
(3) enterprise quality system status report or enterprise quality system assessment (audit) certificate;
(4) State Administration of Pharmaceutical Affairs (provincial medical device management department) recognized by the medical device Product type test report issued by the quality inspection center.
Permit the production of registration is valid for four years, the expiration should be reviewed and renewed.
Implementation of the production license has been implemented for medical device products, the quasi-production registration and production license review combined. Article VIII of the domestic medical device product manufacturers can provide sufficient information to prove that the application for registration of the product's mechanism of action and safety performance and the market legal products are the same or similar to the market in the sale of the product, to ensure the safety and effectiveness, and can provide their own product quality assurance ability to prove, can be accepted by the registration agency to apply for third-party product testing procedures or clinical verification procedures for exemption. Article 9 For the registration of medical device products produced by foreign enterprises, the applicant shall provide:
(1) documents certifying the legal production and business qualifications of the applicant and the producer;
(2) documents certifying the approval of the product to enter the market;
(3) product quality standards;
(4) instructions for the use of the product;
(5) Product quality guarantee of the producer;
(6) Proof of designated service organization in China and related documents.
Provide copies of the supporting documents specified in this article, to be signed by the original certifying authority or the issuance of a notarized document from the notary public in the country (region).
The State Administration of Medicine may, when it deems necessary, assess the medical device products produced by overseas producers applying for registration.
State Administration of Pharmaceutical Affairs that when necessary, may require the application for registration of Class III medical device products producer quality system for on-site verification.