On May 19, 2017, China’s State Council issued the “Supervision and Regulation of Medical Devices (No. 680),” just three years following the State Council Decree No. 650, which addressed similar regulations, including how medical devices should be supervised.
While there are many parallels between the two regulations, there are three significant areas of change that should be noted and highly considered by Chinese medical product manufacturers.
I. As it relates to the configuration and use of large-scale medical equipment, a total of eight of ten regulations were modified to soften language and decrease the stringent regulations surrounding permit approvals for large-scale medical equipment configurations.
The rationale behind this decision pertains to increased and strengthened supervision and management following (vs. prior to) a permit approval. Increased oversight activities will now include additional monitoring and evaluating of the legal (or illegal) use of large-scale medical equipment. As an example, this will include supervision of excessive inspection and treatment of equipment.
Permits will also be tracked within an equipment directory, managed by the State Council Department.
II. Articles 1 and 8 within the new decree (No. 680) address clinical trial institutions and how they are qualified. Moving forward, the China Food & Drug Administration (CFDA) will discontinue on-site inspections to verify whether trial sites meet specific regulations. Alternatively, clinical trial institutions will be verified through permits held given the increased supervision post-permit.
III. Article 6 of the new Decree discusses exemption clauses related to relevant sellers and users of medical device equipment. Outlined is information on exceptions for product performance indicators, purchase acceptance, product composition and registration certificates.
Medical equipment enterprises and users, to employ an exemption, must meet three conditions:
- Adequately perform purchase inspections and other obligations following appropriate regulations;
- Truthfully explain the source of goods; and
- Provide sufficient evidence to prove that medical devices are not required to meet the mandatory standards by the registered/filed product technical requirements.
Below is a further breakdown of the most noteworthy clause modifications for Chinese medical device manufacturers.
| Article # | Original Clause (No. 650) | Modified Clause (No. 680) |
| Article 18 | The clinical trials of medical devices shall be carried out in accordance with the requirements of the quality control standard for clinical trials of medical devices, and shall be carried out in a qualified clinical trial institution and shall be submitted 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 where the clinical trial is located Filing. The food and drug supervision and administration department that accepts the clinical trial shall inform the competent department of food and drug supervision and the department of health care at the same level of the place where the clinical trial institution is located.
Medical equipment clinical trial institutions qualification conditions and clinical trial quality management practices, by the State Council food and drug supervision and management departments in conjunction with the State Council department of health and family planning and published; medical device clinical trial by the State Council food and drug supervision and management departments in conjunction with the State Council Health and Family Planning Department Identified and published. |
The clinical trials of medical devices shall be carried out in accordance with the requirements of the quality control standard for clinical trials of medical devices and shall be carried out in clinical trial institutions with corresponding conditions and shall be supervised by the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government where the clinical trials are located Department for the record. The food and drug supervision and administration department that accepts the clinical trial shall inform the competent department of food and drug supervision and the department of health care at the same level of the place where the clinical trial institution is located.
Medical equipment clinical trial institutions are to implement record management. Medical equipment clinical trial institutions should have the conditions and the record management approach and clinical trial quality management practices, by the State Council food and drug supervision and management departments in conjunction with the State Council department in charge of health development and publication. |
| Article 34 | The Previous Article 34 (No. 650) has merged into a new Article 34 (No. 680). | Medical equipment use units to configure large-scale medical equipment should be in line with the State Council department in charge of health planning to develop large-scale medical equipment configuration planning, and its functional positioning, clinical service needs to adapt, with the appropriate technical conditions, supporting facilities and have the appropriate qualifications, Technical personnel, and by the provincial people’s government above the provincial health department in charge of approval, access to large-scale medical equipment configuration permit.
The management of large-scale medical equipment shall be formulated by the department in charge of hygiene and family planning of the State Council in conjunction with the relevant departments under the State Council. The list of large medical equipment shall be submitted by the relevant department of the State Council department of hygiene and family planning of the State Council and submitted to the State Council for approval. |
| Article 56 | Terms of the original clause remain with the exception of the language to the right. | The department of hygiene shall supervise and evaluate the use of large-scale medical equipment; if it is found that the use of irregularities and excessive examination and over-treatment related to large-scale medical equipment should be corrected immediately and dealt with according to law. |
| Article 64 | The Previous Article 64 (No. 650) has merged into a new Article 64 (No. 680). | If the large-scale medical equipment is used without authorization, the department of health and family planning of the people’s government at or above the county level shall order to stop using it and give a warning and confiscate the illegal gains. If the illegal gains are less than 10,000 yuan, a fine of less than 10,000 yuan, and illegal income of 5 times more than 10 times the fine will be assessed; if the circumstances are serious, 5 years will not accept the relevant responsible person and the unit of large medical equipment configuration permit application.
Whomever obtains false information or obtains other means of obtaining a medical equipment registration certificate, medical device production license, medical device business license, large-scale medical equipment configuration permit, or advertising approval document shall be punished. The department shall revoke the license that has been obtained and impose a fine of not less than 50,000 yuan, but not more than 100,000 yuan, and shall not accept the application for medical device permission from the relevant person and unit within 5 years. |
| Article 66 | Terms of the original clause remain with the exception of the language to the right. | If the use of units to fulfill the provisions of the purchase inspection obligations is conducted by individuals now showing sufficient evidence that they know the operation shall be punished. Individual must be able to accurately explain the source of the purchase, which may exempt them from punishment. Units shall be confiscated if the use of units is in non-compliance with the statutory requirements of medical equipment. |
| Article 69 | Whomever commits a clinical trial of medical devices in violation of the provisions of these regulations shall be ordered by the food and drug supervision and administration department of the people ‘s government at or above the county level to make corrections or to immediately stop the clinical trial and may impose a fine of not more than 50,000 yuan; Directly responsible person in charge and other directly responsible persons to give demotion, dismissal or dismissal of the punishment; a medical device clinical trial institutions qualified by the authority granted to the competent authorities to revoke the medical device clinical testing agency qualification, 5 years without accepting its qualification Application.
Medical equipment clinical trial institutions issued a false report, by the grant of its competent authorities to revoke the medical device clinical trial institutions qualification, 10 years will not accept their qualification application; by the people’s governments above the county level food and drug supervision and management departments at 50,000 yuan or more A fine of not more than 100,000 yuan; the illegal gains shall be confiscated; the person directly in charge and other persons directly responsible shall be given a disciplinary action for dismissal or dismissal according to law. |
Whomever commits a clinical trial of medical devices in violation of the provisions of these Regulations shall be ordered by the food and drug supervision and administration department of the people ‘s government at or above the county level to make corrections or to immediately stop the clinical trial and may impose a fine of not more than 50,000 yuan; Directly responsible person in charge and other directly responsible persons to give demotion, dismissal or dismissal of the punishment; the agency within 5 years shall not carry out the relevant professional medical equipment clinical trials.
Medical equipment clinical test institutions issued a false report by the people’s governments above the county level food and drug supervision and management departments at 50,000 yuan more than 100,000 yuan fine; illegal income, confiscate the illegal income; directly responsible for the person in charge and other direct Responsible personnel, according to the law to give removal or dismissal of the punishment; the agency within 10 years shall not carry out the relevant professional medical equipment clinical trials. |
| Article 73 | The food and drug supervision and administration departments and their staff members shall exercise the administrative penalty power in accordance with the nature and specific circumstances of the illegal acts in strict accordance with the types and extent of the punishment prescribed in these Regulations. The specific measures shall be formulated by the food and drug supervision and administration department under the State Council. | The department of food and drug supervision and administration, the department of hygiene and family planning and its staff shall, in strict accordance with the types and extent of the punishment prescribed in these Regulations, exercise the right of administrative punishment in accordance with the nature and specific circumstances of the illegal acts. The specific measures shall be prescribed by the State Council Food and Drugs Supervision and management departments, health and family planning departments in accordance with their respective responsibilities to develop. |
| Article 76 | Terms of the original clause remain unchanged. The definition of “large-scale medical equipment” has been added in No. 680. | Large-scale medical equipment, refers to the use of complex technology, capital investment, high operating costs, and large impact on medical expenses and into the directory management of large medical equipment. |
Did You Know?
NAMSA has dedicated regulatory experts in China that are ready to discuss your potential medical device development efforts, including your registration strategy, to help identify the most efficient product pathway for your device. NAMSA’s regulatory expertise, coupled with our recently-opened preclinical research laboratory in Shanghai, is providing clients with significant time and cost savings throughout all stages of the development process.
If you’d like to discuss your medical device development project, please contact us at communications@namsa.com. We also invite you to watch the unique, fun video created for our Shanghai lab opening here.
Leah Davidson, MA, MBA, PCM
Leah has been with NAMSA since 2016 and currently serves as Senior Manager of Global Marketing Communications. She possesses nearly 25 years' experience within the medical device and healthcare technology industries and has worked in various marketing and communications capacities throughout her career. In her role at NAMSA, she is responsible for the development and implementation of brand strategies and marketing communications initiatives that help drive the organization's sales and organizational growth goals globally.