About NMPA and trend of Chinese market of medical device

In 2018 National Medical Products Administration (NMPA, Chinese:国家药品监督管理局) replaced former China food and drug administration (CFDA). As one part of State Administration for Market Regulation (SAMR) the NMPA is in charge of supervision of drug, medical device and cosmetics in China. The core task of NMPA is to draft legislative of drug, medical device and cosmetics and to supervise the implementation of the regulations. Besides it, NMPA is also responsible of standards, quality management, registration and post market activities including inspection of abovementioned products. 

*In-vitro Diagnostics Regulation belongs also to regim of NMPA

Responsibility of NMPA

(1) To supervise the safety of drugs (including traditional Chinese medicines (TCMs) and ethno-medicines, the same below), medical devices and cosmetics; to draw up regulatory policy plans, organize the drafting of laws and regulations, formulate normative documents, and supervise the implementation thereof; to research and formulate regulatory and supportive policies that encourage new technologies and new products for drugs, medical devices and cosmetics.

(2) To undertake standards management for drugs, medical devices and cosmetics; to organize the formulation and publication of the Chinese Pharmacopoeia and other drug and medical device standards, organize the drafting of cosmetic standards, organize the formulation of the classification management system, and supervise the implementation thereof; to participate in formulating the National Essential Medicine List, and assist in the implementation of the national essential medicine system.

(3) To regulate the registration of drugs, medical devices and cosmetics; to develop the registration system, conduct strict review and approval for marketing, improve measures to facilitate the review and approval process, and organize the implementation thereof.

(4) To undertake quality management for drugs, medical devices and cosmetics; to develop Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), and supervise the implementation thereof; to develop Good Manufacturing Practices (GMP) and supervise the implementation thereof in line with NMPA's responsibilities; to develop good practices on the distribution and use of medical products and guide the implementation thereof.

(5) To undertake post-market risk management for drugs, medical devices and cosmetics; to organize the monitoring, evaluation, and handling of adverse drug reactions, medical device adverse events, and cosmetic adverse reactions; to undertake emergency response management for drugs, medical devices and cosmetics in accordance with law.

(6) To undertake management of qualifications for licensed pharmacists; to formulate regulations of qualifications for licensed pharmacists, and guide and supervise the registration of licensed pharmacists.

(7) To organize and guide the supervision and inspection of drugs, medical devices and cosmetics; to develop the inspection system, investigate and punish illegal activities during the registration process for drugs, medical devices and cosmetics in accordance with law, and organize and guide the investigation and punishment of illegal activities during the manufacturing process in line with NMPA's responsibilities.

(8) To engage in international exchange and cooperation in the regulation of drugs, medical devices and cosmetics, and participate in developing relevant international regulatory rules and standards.

(9) To guide the work of drug regulatory departments of all provinces, autonomous regions, and municipalities directly under the Central Government.

(10) To complete other tasks assigned by the CPC Central Committee and the State Council.