Circular of the Department of General Affairs of the National Medical Products Administration on the Implementing Measures for the Reform of "Separating Business Licenses from Operating Permits" to Further Advance the Reform of the Medical Device Evaluation, Examination and Approval System
Circular of the Department of General Affairs of the National Medical Products Administration on the Implementing Measures for the Reform of "Separating Business Licenses from Operating Permits" to Further Advance the Reform of the Medical Device Evaluation, Examination and Approval System
Circular of the Department of General Affairs of the National Medical Products Administration on the Implementing Measures for the Reform of "Separating Business Licenses from Operating Permits" to Further Advance the Reform of the Medical Device Evaluation, Examination and Approval System
Yao Jian Zong Xie Zhu [2018] No.43
November 13, 2018
The food and drug administrations (drug administrations) of all provinces, autonomous regions and municipalities directly under the Central Government,
According to the requirements of the Circular of the State Council on Promoting the Reform of "Separating Operating Permits and Business Licenses" across the Country (Guo Fa [2018] No.35, hereinafter referred to as the "Circular"), and in order to further deepen the reform of "Streamlining Administration, Delegating Powers and Improving Administration and Services" and optimize the access services, comprehensively deepen the reform of the evaluation, examination and approval system for medical devices, promote the technology innovation of medical devices, advance the high-quality development of medical devices, and meet the clinical needs of the public, the relevant matters are hereby notified as follows:
I. Overall requirements
The drug regulatory departments of all provinces, autonomous regions, and municipalities directly under the Central Government shall attach great importance to the reform of "Separating Business Licenses from Operating Permits", fully understand the significance thereof, and conscientiously implement the reform by reference to the specific items of the reform as clearly defined in the Circular.
The drug regulatory departments shall, according to the requirements of the Circular, by reference to the released regulations and documents related to medical devices, and in combination with the characteristics of local industry development and the practice of evaluation, examination and approval, formulate the work program, refine the measures for the implementation, and advance the work strictly according to the Circular and their respective work programs.
II.
......
Yao Jian Zong Xie Zhu [2018] No.43
November 13, 2018
The food and drug administrations (drug administrations) of all provinces, autonomous regions and municipalities directly under the Central Government,
According to the requirements of the Circular of the State Council on Promoting the Reform of "Separating Operating Permits and Business Licenses" across the Country (Guo Fa [2018] No.35, hereinafter referred to as the "Circular"), and in order to further deepen the reform of "Streamlining Administration, Delegating Powers and Improving Administration and Services" and optimize the access services, comprehensively deepen the reform of the evaluation, examination and approval system for medical devices, promote the technology innovation of medical devices, advance the high-quality development of medical devices, and meet the clinical needs of the public, the relevant matters are hereby notified as follows:
I. Overall requirements
The drug regulatory departments of all provinces, autonomous regions, and municipalities directly under the Central Government shall attach great importance to the reform of "Separating Business Licenses from Operating Permits", fully understand the significance thereof, and conscientiously implement the reform by reference to the specific items of the reform as clearly defined in the Circular.
The drug regulatory departments shall, according to the requirements of the Circular, by reference to the released regulations and documents related to medical devices, and in combination with the characteristics of local industry development and the practice of evaluation, examination and approval, formulate the work program, refine the measures for the implementation, and advance the work strictly according to the Circular and their respective work programs.
II.
......