The Regulations on the Supervision and Administration of Medical Devices have been revised and approved at the 39th executive meeting of the State Council on February 12, 2014. The revised Regulations on the Supervision and Administration of Medical Devices will be promulgated and will be implemented as of June 1, 2014.
Chapter I General Provisions
Article 1 These Regulations are formulated to ensure the safety and effectiveness of medical devices and to protect human health and life.
Article 2 These Regulations shall be observed in the research, production, operation and use of medical devices and their supervision and management in the territory of the People's Republic of China.
Article 3 The food and drug supervision and administration department of the State Council is responsible for the supervision and administration of medical equipment throughout the country. The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective areas of responsibility.
The food and drug supervision and administration department of the local people's government at or above the county level shall be responsible for the supervision and administration of medical devices in its administrative region. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and management of medical devices within their respective functions and responsibilities.
The food and drug supervision and administration department of the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry plan and policies.
Article 4 The State implements classified management of medical devices according to the degree of risk.
The first category is a medical device that has a low level of risk and is routinely managed to ensure its safety and effectiveness.
The second category is medical devices that have moderate risks and require strict control to ensure their safety and effectiveness.
The third category is medical devices that have high risks and require special measures to strictly control management to ensure their safety and effectiveness.
To evaluate the degree of risk of medical devices, factors such as the intended purpose, structural characteristics, and methods of use of medical devices should be considered.
The food and drug supervision and administration department of the State Council is responsible for formulating the classification rules and classification catalogues of medical devices, and timely analyzing and evaluating the risk changes of medical devices according to the production, operation and use of medical devices, and adjusting the classification catalogue. To formulate and adjust the catalogue, we should fully listen to the opinions of medical device production and operation enterprises, users and industry organizations, and refer to the international medical device classification practice. The medical device classification catalogue should be published to the public.
Article 5 The development of medical devices shall follow the principles of safety, efficiency and economy. The state encourages the research and innovation of medical devices, plays the role of market mechanisms, promotes the promotion and application of new medical device technologies, and promotes the development of the medical device industry.
Article 6 Medical device products shall comply with the mandatory national standards for medical devices; if there are no mandatory national standards, they shall comply with the compulsory industry standards for medical devices.
The catalogue of disposable medical devices shall be formulated, adjusted and announced by the food and drug supervision and administration department of the State Council in conjunction with the competent department of health and family planning of the State Council. Reuse can ensure safe and effective medical devices and is not included in the single-use medical device catalog. For medical devices that are safe and effective for repeated use due to improvements in design, production processes, disinfection and sterilization techniques, the catalogue of disposable medical devices should be adjusted.
Article 7 Medical device industry organizations shall strengthen self-discipline in the industry, promote the construction of a credit system, urge enterprises to carry out production and operation activities according to law, and guide enterprises to be honest and trustworthy.
Chapter II Registration and Filing of Medical Device Products
Article 8 The first type of medical devices shall be subject to product registration management, and the second and third types of medical devices shall be subject to product registration management.
Article 9 For the filing of the first category of medical device products and for the registration of Class II and Class III medical device products, the following information shall be submitted:
(1) Product risk analysis data;
(2) Product technical requirements;
(3) Product inspection report;
(4) Clinical evaluation data;
(5) Product specifications and label samples;
(6) Quality management system documents related to product development and production;
(7) Other materials required to prove that the product is safe and effective.
The applicant for medical device registration and the filer shall be responsible for the authenticity of the submitted materials.
Article 10 The first type of medical device products shall be filed, and the record-issuing person shall submit the filing materials to the food and drug supervision and administration department of the municipal people's government at the locality. The product inspection report may be a self-inspection report of the record holder; the clinical evaluation data does not include the clinical test report, and may be a document that proves the safe and effective information of the medical device through data obtained by clinical use of the literature and similar products.
An overseas production enterprise that exports the first type of medical equipment to China shall be represented by its representative office established in China or an enterprise legal person designated within the territory of China, and submit the filing materials and the country of the record holder to the food and drug supervision and administration department of the State Council ( Regional) The competent authority authorizes the documentation of the sale of the medical device.
Where the matters specified in the filing materials change, the original filing department shall be changed and filed.
Article 11 When applying for the registration of the second category of medical device products, the applicant for registration shall submit the application for registration to the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government. To apply for the registration of the third category of medical device products, the applicant for registration shall submit the application for registration to the Food and Drug Administration of the State Council.
An overseas production enterprise that exports Class II and Class III medical devices to China shall submit its application for registration to the Food and Drug Administration of the State Council as an agent of its representative office established within the territory of China or an enterprise legal person designated within the territory of China. And the certification document that the competent authority of the country where the applicant is registered permits the sale of the medical device.
The product inspection report in the application materials for registration of the second and third types of medical device products shall be the inspection report issued by the medical device inspection organization; the clinical evaluation data shall include the clinical test report, but shall be exempted from the provisions of Article 17 of these Regulations. Except for medical devices that perform clinical trials.
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