Regulations on the Supervision and Administration of Medical Devices (Revised in 2024)
Regulations on the Supervision and Administration of Medical Devices (Revised in 2024)
Regulations on the Supervision and Administration of Medical Devices (Revised in 2024)
Order of the State Council of the People's Republic of China No. 797
December 6, 2024
(Promulgated by Order of the State Council of the People's Republic of China No. 276 on January 4, 2000; revised and adopted at the 39th Executive Meeting of the State Council on February 12, 2014; revised for the first time in accordance with the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017; revised and adopted at the 119th Executive Meeting of the State Council on December 21, 2020; revised for the second time in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on December 6, 2024)
Chapter I General Provisions
Article 1 The Regulations are formulated to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry.
Article 2 The Regulations shall apply to the research and development, production, operation, and use of medical devices, as well as supervision and administration thereof within the territory of the People's Republic of China.
Article 3 The medical products administration under the State Council shall be responsible for the supervision and administration of medical devices nationwide.
Relevant authorities under the State Council shall be responsible for the supervision and administration related to medical devices within their respective duties.
Article 4 Local people's governments at or above the county level shall strengthen the leadership of the supervision and administration of medical devices in their respective administrative regions, organize and coordinate the supervision and administration of medical devices and emergency response in their respective administrative regions, enhance the capacity building for the supervision and administration of medical devices, and provide guarantees for the safety of medical devices.
The authorities responsible for medical products supervision and administration in local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices in their respective administrative regions. Relevant authorities of local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective duties.
Article 5 The supervision and administration of medical devices shall follow the principles of risk management, full-process control, scientific regulation, and social co-governance.
Article 6 The State shall implement classified management of medical devices according to the degree of risk.
Class I refers to medical devices with low risk, whose safety and efficacy can be ensured through routine management.
Class II refers to medical devices with moderate risk, whose safety and efficacy require strict control in management.
Class III refers to medical devices with relatively high risk, whose safety and efficacy require special strict control measures in management.
When evaluating the risk level of medical devices, factors such as the intended purpose, structural characteristics, and use methods of medical devices shall be considered.
The medical products administration under the State Council shall be responsible for formulating the classification rules and catalogs of medical devices, and based on the production, operation, and use of medical devices, analyzing and evaluating changes in their risks in a timely manner, and adjusting the classification rules and catalogs. When formulating and adjusting the classification rules and catalogs, the opinions of medical device registrants, filers, manufacturers, distributors, users, and industry organizations shall be fully solicited, and international practices in medical device classification shall be taken into account. The classification rules and catalogs of medical device shall be made available to the public.
Article 7 Medical device products shall comply with the mandatory national standards for medical devices; in the absence of such mandatory national standards, they shall comply with the mandatory industry standards for medical devices.
Article 8 The State shall formulate plans and policies for the medical device industry, incorporate innovation in medical devices into development priorities, give priority to the review and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of the medical device industry. The medical products administration under the State Council shall cooperate with relevant authorities under the State Council to implement the national plans and guiding policies for the medical device industry.
Article 9 The State shall improve the innovation system for medical devices, support basic and applied research on medical devices, facilitate the promotion and application of new technologies in medical devices, and provide support in areas such as scientific project approval, financing, credit, procurement through bidding, and medical insurance. Efforts shall be made to support enterprises in establishing or jointly forming research and development institutions, encourage enterprises to collaborate with colleges and universities, scientific research institutes, and medical institutions in carrying out research and innovation in medical devices, strengthen the protection of intellectual property rights in medical devices, and enhance the independent innovation capability related to medical devices.
Article 10 The State shall strengthen the development of information technology for the supervision and administration of medical devices, improve online government services, and provide convenience for administrative licensing, filing, and other processes related to medical devices.
Article 11 Medical device industry organizations shall strengthen industry self-discipline, promote the construction of a credibility system, supervise and urge enterprises to conduct production and operation activities in accordance with the law, and guide enterprises to be honest and trustworthy.
Article 12 Entities and individuals that make outstanding contributions to research and innovation in medical devices shall be commended and rewarded in accordance with relevant national provisions.
Chapter II Registration and Filing of Medical Device Products
Article 13 Class I medical devices shall be subject to product filing management, while Class II and Class III medical devices shall be subject to product registration management.
Medical device registrants and filers shall strengthen the quality management throughout the lifecycle of medical devices and assume responsibility in accordance with the law for the safety and efficacy of medical devices throughout the processes of research and development, production, operation, and use.
Article 14 For the filing of Class I medical device products and the application for registration of Class II and Class III medical device products, the following materials shall be submitted:
(1) Product risk analysis materials;
(2) Product technical requirements;
(3) Product inspection report;
(4) Clinical evaluation materials;
(5) Product instructions and label samples;
(6) Quality management system documents related to product research and development and production; and
(7) Other materials necessary to prove the safety and efficacy of products.
The product inspection report shall comply with the requirements of the medical products administration under the State Council. It may be a self-inspection report from the medical device registrant or filer, or an inspection report issued by a qualified medical device inspection institution commissioned for the purpose.
If the circumstances for exemption from clinical evaluation as specified in Article 24 of the Regulations are met, the submission of clinical evaluation materials may be exempted.
Medical device registration applicants and filers shall ensure that the submitted materials are legal, authentic, accurate, complete, and traceable.
Article 15 For the filing of Class I medical device products, the filer shall submit the filing materials to the authority responsible for medical products supervision and administration in the people's government at the level of city divided into districts where the filer is located.
For an overseas filer exporting Class I medical devices to China, the domestic enterprise legal person designated by such filer shall submit the filing materials and the certificate issued by the authority of the country (region) where such filer is located on permitting the marketing of such medical devices to the medical products administration under the State Council. For innovative medical devices that have not been marketed overseas, the certificate issued by the authority of the country (region) where the filer is located on permitting the marketing of such medical devices may not be submitted.
A filing is deemed completed upon the submission of the filing materials that comply with the provisions of the Regulations by the filer to the authority responsible for medical products supervision and administration. The authority responsible for medical products supervision and administration shall, within five working days from the date of receipt of the filing materials, publish the relevant filing information to the public through the online government service platform of the medical products administration under the State Council.
In the case of any changes in the matters specified in the filing materials, the filer shall apply for a change of filing with the original filing authority.
Article 16 To apply for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. To apply for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the medical products administration under the State Council.
For an overseas registration applicant exporting Class II and Class III medical devices to China, the domestic enterprise legal person designated by such applicant shall submit the registration application materials and the certificate issued by the authority of the country (region) where such application is located on permitting the marketing of such medical devices to the medical products administration under the State Council. For innovative medical devices that have not been marketed overseas, the certificate issued by the authority of the country (region) where the registration applicant is located on permitting the marketing of such medical devices may not be submitted.
The medical products administration under the State Council shall establish the registration review procedures and requirements for medical devices and strengthen supervision and guidance of the registration review conducted by the medical products administrations of people's governments of provinces, autonomous regions, and municipality directly under the Central Government.
Article 17 The medical products administration accepting a registration application shall review the safety and efficacy of related medical devices, as well as the quality management capability of the registration applicant to ensure the safety and efficacy of related medical devices.
The medical products administration accepting the registration application shall, within three working days from the date of acceptance, transfer the registration application materials to the technical evaluation institution. The technical evaluation institution shall, after completing the technical evaluation, submit its evaluation opinions to the medical products administration accepting the registration application as the basis for approval.
If the medical products administration accepting the registration application deems it necessary to verify the quality management system during the organization of the technical evaluation of related medical devices, it shall organize the verification of the quality management system.
Article 18 The medical products administration accepting a registration application shall make a decision within 20 working days from the date of receiving the evaluation opinions. If the application meets the conditions, it shall approve the registration and issue a medical device registration certificate; if the application does not meet the conditions, it shall disapprove the registration with a written explanation of the reasons.
The medical products administration accepting the registration application shall, within five working days from the date of approval for the registration of medical devices, publish the relevant registration information to the public through the online government service platform of the medical products administration under the State Council.
Article 19 For medical devices urgently needed for the treatment of rare diseases and serious diseases that pose a life-threatening risk for which no effective treatment is available, and for responding to public health emergencies, the medical products administration accepting the registration application may make a conditional approval decision and specify relevant matters in the medical device registration certificate.
In the event of a particularly serious public health emergency or any other urgent incident that seriously threatens public health, the health authority under the State Council and the disease prevention and control authority under the State Council may, based on the needs for prevention and control of the incident, propose the emergency use of medical devices; upon approval by the medical products administration under the State Council following an organized assessment, such devices may be used on an emergency basis within a specified scope and timeframe.
Article 20 Medical device registrants and filers shall fulfill the following obligations:
(1) Establish a quality management system that is appropriate for products and maintain its effective operation;
(2) Develop post-marketing research and risk control plans and ensure their effective implementation;
(3) Conduct adverse event monitoring and re-evaluation in accordance with the law;
(4) Establish and implement a product traceability and recall system; and
(5) Other obligations as stipulated by the medical products administration under the State Council.
The domestic enterprise legal person designated by an overseas medical device registrant or filer shall assist such registrant or filer in fulfilling the obligations specified in the preceding paragraph.
Article 21 If any registered Class II or Class III medical devices substantially change in design, raw materials, production processes, scope of application, or use methods, which may affect the safety and efficacy of such medical devices, the registrant shall apply for change of registration to the original registration authority; in the case of any other changes, the matter shall be filed or reported in accordance with the provisions of the medical products administration under the State Council.
Article 22 A medical device registration certificate shall be valid for five years. If the registration needs to be renewed upon expiration, an application for renewal shall be submitted to the original registration authority six months before the expiration of the validity period.
Except for the circumstances specified in Paragraph 3 of this article, the medical products administration receiving the application for renewal of registration shall make a decision to grant the renewal before the expiration of the medical device registration certificate. If no decision is made within the prescribed time limit, the renewal shall be deemed granted.
Under any of the following circumstances, the renewal shall not be granted:
(1) No application for renewal is submitted within the specified time limit;
(2) The mandatory standards for the medical device have been revised, and the medical device for which renewal of registration is applied cannot meet the new requirements; or
(3) For a conditionally approved medical device, the matters specified in the medical device registration certificate have not completed within the specified time limit.
Article 23 For a newly developed medical device that has not yet been included in the classification catalog, the applicant may directly apply for product registration in accordance with the provisions of the Regulations on the registration of Class III medical device products, or may determine the product category based on classification rules and apply for category confirmation to the medical products administration under the State Council before applying for product registration or filing in accordance with the provisions of the Regulations.
In the case of any direct application for registration of Class III medical device products, the medical products administration under the State Council shall determine the category based on the level of risk and promptly include the medical devices that have been granted registration in the classification catalog. In the case of an application for category confirmation, the medical products administration under the State Council shall, within 20 working days from the date of acceptance of the application, determine the category of the medical device and inform the applicant.
Article 24 The registration and filing of medical device products shall be supported by clinical evaluation; however, under any of the following circumstances, clinical evaluation may be exempted:
(1) The medical device has a clearly defined working mechanism, a finalized design, and mature manufacturing processes; a similar type of medical device already on the market has been used in clinical practice for many years with no record of serious adverse events, and the intended use of the device is unchanged; or
(2) Other circumstances in which the safety and efficacy of the medical device can be demonstrated through non-clinical evaluation.
The medical products administration under the State Council shall formulate guidelines for the clinical evaluation of medical devices.
Article 25 For the clinical evaluation of medical devices, the safety and efficacy of the devices may be demonstrated by conducting clinical trials, or by analyzing and evaluating clinical literature and clinical data of similar types of medical devices, based on product characteristics, clinical risks, and existing clinical data.
According to the provisions of the medical products administration under the State Council, when conducting the clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the safety and efficacy of the devices, clinical trials shall be conducted.
Article 26 The clinical trials of medical devices shall be conducted at a qualified clinical trial institution in accordance with the good clinical practice for medical devices and filed with the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial sponsor is located.
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Order of the State Council of the People's Republic of China No. 797
December 6, 2024
(Promulgated by Order of the State Council of the People's Republic of China No. 276 on January 4, 2000; revised and adopted at the 39th Executive Meeting of the State Council on February 12, 2014; revised for the first time in accordance with the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017; revised and adopted at the 119th Executive Meeting of the State Council on December 21, 2020; revised for the second time in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on December 6, 2024)
Chapter I General Provisions
Article 1 The Regulations are formulated to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry.
Article 2 The Regulations shall apply to the research and development, production, operation, and use of medical devices, as well as supervision and administration thereof within the territory of the People's Republic of China.
Article 3 The medical products administration under the State Council shall be responsible for the supervision and administration of medical devices nationwide.
Relevant authorities under the State Council shall be responsible for the supervision and administration related to medical devices within their respective duties.
Article 4 Local people's governments at or above the county level shall strengthen the leadership of the supervision and administration of medical devices in their respective administrative regions, organize and coordinate the supervision and administration of medical devices and emergency response in their respective administrative regions, enhance the capacity building for the supervision and administration of medical devices, and provide guarantees for the safety of medical devices.
The authorities responsible for medical products supervision and administration in local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices in their respective administrative regions. Relevant authorities of local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective duties.
Article 5 The supervision and administration of medical devices shall follow the principles of risk management, full-process control, scientific regulation, and social co-governance.
Article 6 The State shall implement classified management of medical devices according to the degree of risk.
Class I refers to medical devices with low risk, whose safety and efficacy can be ensured through routine management.
Class II refers to medical devices with moderate risk, whose safety and efficacy require strict control in management.
Class III refers to medical devices with relatively high risk, whose safety and efficacy require special strict control measures in management.
When evaluating the risk level of medical devices, factors such as the intended purpose, structural characteristics, and use methods of medical devices shall be considered.
The medical products administration under the State Council shall be responsible for formulating the classification rules and catalogs of medical devices, and based on the production, operation, and use of medical devices, analyzing and evaluating changes in their risks in a timely manner, and adjusting the classification rules and catalogs. When formulating and adjusting the classification rules and catalogs, the opinions of medical device registrants, filers, manufacturers, distributors, users, and industry organizations shall be fully solicited, and international practices in medical device classification shall be taken into account. The classification rules and catalogs of medical device shall be made available to the public.
Article 7 Medical device products shall comply with the mandatory national standards for medical devices; in the absence of such mandatory national standards, they shall comply with the mandatory industry standards for medical devices.
Article 8 The State shall formulate plans and policies for the medical device industry, incorporate innovation in medical devices into development priorities, give priority to the review and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of the medical device industry. The medical products administration under the State Council shall cooperate with relevant authorities under the State Council to implement the national plans and guiding policies for the medical device industry.
Article 9 The State shall improve the innovation system for medical devices, support basic and applied research on medical devices, facilitate the promotion and application of new technologies in medical devices, and provide support in areas such as scientific project approval, financing, credit, procurement through bidding, and medical insurance. Efforts shall be made to support enterprises in establishing or jointly forming research and development institutions, encourage enterprises to collaborate with colleges and universities, scientific research institutes, and medical institutions in carrying out research and innovation in medical devices, strengthen the protection of intellectual property rights in medical devices, and enhance the independent innovation capability related to medical devices.
Article 10 The State shall strengthen the development of information technology for the supervision and administration of medical devices, improve online government services, and provide convenience for administrative licensing, filing, and other processes related to medical devices.
Article 11 Medical device industry organizations shall strengthen industry self-discipline, promote the construction of a credibility system, supervise and urge enterprises to conduct production and operation activities in accordance with the law, and guide enterprises to be honest and trustworthy.
Article 12 Entities and individuals that make outstanding contributions to research and innovation in medical devices shall be commended and rewarded in accordance with relevant national provisions.
Chapter II Registration and Filing of Medical Device Products
Article 13 Class I medical devices shall be subject to product filing management, while Class II and Class III medical devices shall be subject to product registration management.
Medical device registrants and filers shall strengthen the quality management throughout the lifecycle of medical devices and assume responsibility in accordance with the law for the safety and efficacy of medical devices throughout the processes of research and development, production, operation, and use.
Article 14 For the filing of Class I medical device products and the application for registration of Class II and Class III medical device products, the following materials shall be submitted:
(1) Product risk analysis materials;
(2) Product technical requirements;
(3) Product inspection report;
(4) Clinical evaluation materials;
(5) Product instructions and label samples;
(6) Quality management system documents related to product research and development and production; and
(7) Other materials necessary to prove the safety and efficacy of products.
The product inspection report shall comply with the requirements of the medical products administration under the State Council. It may be a self-inspection report from the medical device registrant or filer, or an inspection report issued by a qualified medical device inspection institution commissioned for the purpose.
If the circumstances for exemption from clinical evaluation as specified in Article 24 of the Regulations are met, the submission of clinical evaluation materials may be exempted.
Medical device registration applicants and filers shall ensure that the submitted materials are legal, authentic, accurate, complete, and traceable.
Article 15 For the filing of Class I medical device products, the filer shall submit the filing materials to the authority responsible for medical products supervision and administration in the people's government at the level of city divided into districts where the filer is located.
For an overseas filer exporting Class I medical devices to China, the domestic enterprise legal person designated by such filer shall submit the filing materials and the certificate issued by the authority of the country (region) where such filer is located on permitting the marketing of such medical devices to the medical products administration under the State Council. For innovative medical devices that have not been marketed overseas, the certificate issued by the authority of the country (region) where the filer is located on permitting the marketing of such medical devices may not be submitted.
A filing is deemed completed upon the submission of the filing materials that comply with the provisions of the Regulations by the filer to the authority responsible for medical products supervision and administration. The authority responsible for medical products supervision and administration shall, within five working days from the date of receipt of the filing materials, publish the relevant filing information to the public through the online government service platform of the medical products administration under the State Council.
In the case of any changes in the matters specified in the filing materials, the filer shall apply for a change of filing with the original filing authority.
Article 16 To apply for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. To apply for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the medical products administration under the State Council.
For an overseas registration applicant exporting Class II and Class III medical devices to China, the domestic enterprise legal person designated by such applicant shall submit the registration application materials and the certificate issued by the authority of the country (region) where such application is located on permitting the marketing of such medical devices to the medical products administration under the State Council. For innovative medical devices that have not been marketed overseas, the certificate issued by the authority of the country (region) where the registration applicant is located on permitting the marketing of such medical devices may not be submitted.
The medical products administration under the State Council shall establish the registration review procedures and requirements for medical devices and strengthen supervision and guidance of the registration review conducted by the medical products administrations of people's governments of provinces, autonomous regions, and municipality directly under the Central Government.
Article 17 The medical products administration accepting a registration application shall review the safety and efficacy of related medical devices, as well as the quality management capability of the registration applicant to ensure the safety and efficacy of related medical devices.
The medical products administration accepting the registration application shall, within three working days from the date of acceptance, transfer the registration application materials to the technical evaluation institution. The technical evaluation institution shall, after completing the technical evaluation, submit its evaluation opinions to the medical products administration accepting the registration application as the basis for approval.
If the medical products administration accepting the registration application deems it necessary to verify the quality management system during the organization of the technical evaluation of related medical devices, it shall organize the verification of the quality management system.
Article 18 The medical products administration accepting a registration application shall make a decision within 20 working days from the date of receiving the evaluation opinions. If the application meets the conditions, it shall approve the registration and issue a medical device registration certificate; if the application does not meet the conditions, it shall disapprove the registration with a written explanation of the reasons.
The medical products administration accepting the registration application shall, within five working days from the date of approval for the registration of medical devices, publish the relevant registration information to the public through the online government service platform of the medical products administration under the State Council.
Article 19 For medical devices urgently needed for the treatment of rare diseases and serious diseases that pose a life-threatening risk for which no effective treatment is available, and for responding to public health emergencies, the medical products administration accepting the registration application may make a conditional approval decision and specify relevant matters in the medical device registration certificate.
In the event of a particularly serious public health emergency or any other urgent incident that seriously threatens public health, the health authority under the State Council and the disease prevention and control authority under the State Council may, based on the needs for prevention and control of the incident, propose the emergency use of medical devices; upon approval by the medical products administration under the State Council following an organized assessment, such devices may be used on an emergency basis within a specified scope and timeframe.
Article 20 Medical device registrants and filers shall fulfill the following obligations:
(1) Establish a quality management system that is appropriate for products and maintain its effective operation;
(2) Develop post-marketing research and risk control plans and ensure their effective implementation;
(3) Conduct adverse event monitoring and re-evaluation in accordance with the law;
(4) Establish and implement a product traceability and recall system; and
(5) Other obligations as stipulated by the medical products administration under the State Council.
The domestic enterprise legal person designated by an overseas medical device registrant or filer shall assist such registrant or filer in fulfilling the obligations specified in the preceding paragraph.
Article 21 If any registered Class II or Class III medical devices substantially change in design, raw materials, production processes, scope of application, or use methods, which may affect the safety and efficacy of such medical devices, the registrant shall apply for change of registration to the original registration authority; in the case of any other changes, the matter shall be filed or reported in accordance with the provisions of the medical products administration under the State Council.
Article 22 A medical device registration certificate shall be valid for five years. If the registration needs to be renewed upon expiration, an application for renewal shall be submitted to the original registration authority six months before the expiration of the validity period.
Except for the circumstances specified in Paragraph 3 of this article, the medical products administration receiving the application for renewal of registration shall make a decision to grant the renewal before the expiration of the medical device registration certificate. If no decision is made within the prescribed time limit, the renewal shall be deemed granted.
Under any of the following circumstances, the renewal shall not be granted:
(1) No application for renewal is submitted within the specified time limit;
(2) The mandatory standards for the medical device have been revised, and the medical device for which renewal of registration is applied cannot meet the new requirements; or
(3) For a conditionally approved medical device, the matters specified in the medical device registration certificate have not completed within the specified time limit.
Article 23 For a newly developed medical device that has not yet been included in the classification catalog, the applicant may directly apply for product registration in accordance with the provisions of the Regulations on the registration of Class III medical device products, or may determine the product category based on classification rules and apply for category confirmation to the medical products administration under the State Council before applying for product registration or filing in accordance with the provisions of the Regulations.
In the case of any direct application for registration of Class III medical device products, the medical products administration under the State Council shall determine the category based on the level of risk and promptly include the medical devices that have been granted registration in the classification catalog. In the case of an application for category confirmation, the medical products administration under the State Council shall, within 20 working days from the date of acceptance of the application, determine the category of the medical device and inform the applicant.
Article 24 The registration and filing of medical device products shall be supported by clinical evaluation; however, under any of the following circumstances, clinical evaluation may be exempted:
(1) The medical device has a clearly defined working mechanism, a finalized design, and mature manufacturing processes; a similar type of medical device already on the market has been used in clinical practice for many years with no record of serious adverse events, and the intended use of the device is unchanged; or
(2) Other circumstances in which the safety and efficacy of the medical device can be demonstrated through non-clinical evaluation.
The medical products administration under the State Council shall formulate guidelines for the clinical evaluation of medical devices.
Article 25 For the clinical evaluation of medical devices, the safety and efficacy of the devices may be demonstrated by conducting clinical trials, or by analyzing and evaluating clinical literature and clinical data of similar types of medical devices, based on product characteristics, clinical risks, and existing clinical data.
According to the provisions of the medical products administration under the State Council, when conducting the clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the safety and efficacy of the devices, clinical trials shall be conducted.
Article 26 The clinical trials of medical devices shall be conducted at a qualified clinical trial institution in accordance with the good clinical practice for medical devices and filed with the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial sponsor is located.
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