The medical device referred to in these regulations refers to instruments, equipment, appliances, materials or other items, including the required software, used individually or in combination in the human body; its use on the human body surface and in vivo is not obtained by pharmacological, immunological or metabolic means, but may have the participation of these means and play a certain role in assisting; and its use is intended to achieve the following purposes:
(a) prevention, diagnosis, treatment, monitoring, alleviation of disease;
(b) diagnosis, treatment, monitoring, alleviation, alleviation of injury or disability. p>(i) the prevention, diagnosis, treatment, supervision, and alleviation of disease;
(ii) the diagnosis, treatment, supervision, alleviation, and compensation of injury or disability;
(iii) the study, substitution, and regulation of anatomical or physiological processes;
(iv) pregnancy control. The Drug Administration of the State Council is responsible for the supervision and management of medical devices throughout the country.
The drug supervision and management department of the local people's government at or above the county level is responsible for the supervision and management of medical devices in its administrative area.
The drug supervision and management department of the state council shall cooperate with the state council economic comprehensive management department, the implementation of national medical device industrial policy. The state of medical devices to implement classification management.
The first category refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices.
The second category refers to the safety and effectiveness of medical devices should be controlled.
The third category refers to the implantation of the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
Medical device classification directory by the State Council drug supervision and management department based on the rules of classification of medical devices, the State Council administrative department of health to develop, adjust and publish. The state encourages the development of new medical device products. New medical device products, refers to the domestic market has not yet appeared or safety, effectiveness and product mechanism has not been recognized by the domestic brand-new varieties.
The clinical trial of new products of Class II and Class III medical devices shall be conducted in accordance with the provisions of the State Council Drug Administration, after approval.
Completion of clinical trials and through the State Council drug supervision and management department of the State Council to organize expert review of new medical device products, by the State Council drug supervision and management department for approval, and issue new product certificates. The state of medical devices to implement product production registration system.
Production of Class I medical devices, by the municipal people's government of the district-level drug supervision and management department for examination and approval, and issued a certificate of registration of product production.
Production of Class II medical devices, by the provincial, autonomous regions, municipalities directly under the Central People's Government Drug Administration for examination and approval, and issued a certificate of registration of product production.
Production of Class III medical devices, by the State Council Drug Administration for examination and approval, and issued a certificate of registration of product production.
Production of Class II and Class III medical devices, should be clinically validated. Provinces, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department is responsible for the approval of the administrative region of the second class of medical devices clinical trial or clinical verification. Drug supervision and management department of the State Council is responsible for approving the clinical trial or clinical verification of Class III medical devices.
Clinical trial or clinical verification should be in the provincial people's government drug supervision and management department designated medical institutions. Clinical trial or clinical verification of medical institutions, should be in line with the provisions of the State Council drug supervision and management department.
The qualifications of the medical institutions for clinical trial or clinical verification shall be determined by the drug administration department of the State Council in conjunction with the health administration department of the State Council. Medical institutions in accordance with the clinical needs of the unit, can develop medical devices, under the guidance of a licensed physician to use in the unit.
The second class of medical devices developed by medical institutions shall be reported to the people's government at or above the provincial level drug supervision and management department for review and approval; the third class of medical devices developed by medical institutions shall be reported to the State Council drug supervision and management department for review and approval. Declaration of registered medical devices, should be submitted in accordance with the provisions of the State Council drug supervision and management department of technical indicators, test reports and other relevant information.
The municipal people's government drug supervision and management department shall accept the application from the date of thirty working days, to make a decision on whether to give registration; not registered, shall state the reasons in writing.
Provincial, autonomous regions, municipalities directly under the Central People's Government Drug Administration shall accept the application from the date of sixty working days, to make a decision on whether to give registration; not registered, shall state the reasons in writing.
The State Council Drug Administration shall, within ninety working days from the date of acceptance of the application, to make a decision on whether to grant registration; not registered, shall state the reasons in writing. Medical device product registration certificate is valid for four years. The licensee shall apply for re-registration within six months before the expiration of the product registration certificate.
Continuous suspension of production for more than two years, the product production certificate of registration shall lapse. Production of medical devices, should be in line with national standards for medical devices; no national standards, should be in line with the medical device industry standards.
The national standards for medical devices by the State Council administrative department in charge of standardization, in conjunction with the State Council drug supervision and management department. Medical device industry standards set by the State Council drug supervision and management department. Medical device manufacturers shall meet the following conditions:
(a) with its production of medical devices appropriate professional and technical personnel;
(b) with its production of medical devices compatible with the production site and the environment;
(c) with its production of medical devices compatible with the production of equipment;
(d) with the quality inspection of the medical device products produced by the Medical device products for quality inspection of the organization or personnel and inspection equipment. The opening of the first class of medical device manufacturers, should be to the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for the record.
To start the second, third class medical device manufacturers, should be by the provincial, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management department for examination and approval, and issued a "medical device manufacturer license. No "medical device manufacturer license", the administrative department for industry and commerce shall not issue a business license.
"Medical Device Manufacturer License" is valid for five years, the expiration of the validity period should be re-examined and issued. Specific measures developed by the State Council drug supervision and management department. Medical device business enterprises shall meet the following conditions:
(a) with its operation of medical equipment business sites and environment;
(b) with its operation of medical equipment quality inspection personnel;
(c) with its operation of medical equipment products compatible with technical training, maintenance and other after-sales service capabilities. The opening of the first class of medical equipment business enterprises, should be to the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for the record.
To start the second, third class medical equipment business enterprises, should be the province, autonomous region, municipality directly under the central people's government drug supervision and management department for examination and approval, and issued "medical equipment business license. No "medical equipment business license", the administrative department for industry and commerce shall not issue business license.
"Medical Device Business License" is valid for five years, the expiration of the validity period should be re-examined and issued. Specific measures developed by the State Council drug supervision and management department. Medical equipment business enterprises and medical institutions should obtain "medical equipment manufacturer license" from the production company or obtain "medical equipment business license" business enterprises to purchase qualified medical equipment, and inspection of product certification.
Medical equipment business enterprises shall not operate unregistered, no proof of conformity, expired, invalid or obsolete medical devices.
Medical institutions shall not use unregistered, no proof of conformity, expired, invalid or obsolete medical devices. The state of medical device testing organizations to implement qualification recognition system. By the state council drug supervision and management department in conjunction with the state council quality and technical supervision department recognized testing organizations, before the implementation of medical device testing.
Medical device testing organizations and their personnel to be tested by the unit of technical information confidentiality obligations, and shall not engage in or participate in the testing of medical devices related to the development, production, operation and technical consulting activities. Medical device advertisements shall be examined and approved by the drug supervision and management department of the people's government at or above the provincial level; without approval, shall not be published, broadcast, distributed and posted.
The content of medical device advertisements shall be based on the instructions for use approved by the drug administration department of the State Council or the people's government of the provinces, autonomous regions and municipalities directly under the Central Government.