- What are the central authorities in charge of medical devices in various countries?
United States Food and Drug Administration (FDA) Attached to United States Department of Health, Education, and Welfare, is in charge of the administration of drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies throughout the country. Taiwan Taiwan Food and Drug (TFDA) Attached to the Ministry of Health and Welfare, Republic of China, is in charge of the administration and supervision of food and drugs. European Union CE certification Medical devices regulations, MDR; Regulation (EU) 2017/745
In vitro diagnostic devices regulations, IVDR; Regulation (EU) 2017/746)
- What is China’s central authority in charge of medical devices?
It is the National Medical Products Administration (NMPA).
- What is the transformation process of China’s central authority in charge of medical devices?
In 1998, State Pharmaceutical Administration was merged with the Bureau of Drug Administration of the Ministry of Public Health, and State Drug Administration (SDA) directly under the State Council was established.
In 2003, State Food and Drug Administration (SFDA) was established on the basis of the State Drug Administration (SDA), directly under the State council.
In 2013, SFDA was changed to China Food and Drug Administration (CFDA), which was separated from the Ministry of Public Health and returned to the State Council.
In 2018, the National Medical Products Administration (NMPA) was established under the administration of the State Administration for Market Regulation directly under the State Council. Level-to-level administration is implemented for market regulation. Drug Regulatory Administration is only set up at the provincial level (Level 1), and the regulation of drug operation and marketing is undertaken by market regulatory departments at the city and county levels (Level 2).
- Medical Devices in China
“醫療器材” in Taiwan and “醫療器械” in China both refer to medical devices.
Regarding medical devices in China, according to the definition of Article 76 of Regulation on the Supervision and Administration of Medical Devices, “Medical devices” are the instrument, equipment, appliance, in vitro diagnostic reagent or calibrator, material, and other similar or relevant articles directly or indirectly contacting human body, including necessary computer software; the effectiveness is obtained mainly through physical means other than pharmacological, immunological or metabolic ways, or such ways are involved but only play auxiliary roles. They are used to achieve the following intended objectives: diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring, treatment, alleviation, or functional compensation for an injury or handicap conditions; inspection, substitution, regulation or support of physiological structures or physiological process; support or sustainability of life; control of pregnancy; examination of human body samples to provide information for medical or diagnostic purpose.
- How are medical devices classified and graded in China?
On August 1, 2018, the new version of Medical Device Classification Directory was formally implemented, with a total of 22 categories. In Vitro Diagnostics (IVD) has a separate chapter.
- About NMPA registration and production in China, what is the legal source basis standard of the medical device quality management system?
Good Manufacturing Practice for Medical Devices and YY0287-2017-Medical Devices-Quality Management Systems-Requirements for regulatory purposes/ISO 13485:2016 need to be met at the same time.
- About domestic production, what is the Medical Devices Marketing Authorization Holder (MAH) System?
Marketing Authorization Holder (MAH) System refers to the management mode of separating the marketing authorization from the production permit. On August 1, 2019, NMPA issued a notice to extend the pilot project of medical device registrant system (GUO YAO JIAN XIE ZHU (2019) No. 33) to 21 provinces/municipalities in China, including Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan and Shaanxi. An applicant for medical device registration (hereinafter referred to as “the applicant”) who applies for and obtains a medical device registration certificate shall become a medical device registrant (hereinafter referred to as “the registrant”). The applicant may entrust an enterprise with the corresponding production capacity to produce samples, and the registrant may entrust the licensed product to one or more enterprises with the production capacity for production. The biggest difference is that the registration and production of medical devices used to be “bundled” together, which must be completed by the same business entity; this system can be regarded as indicating that China’s national policy on medical devices has gradually been integrated with the international practice (i.e., separation of production and license).
- The role played by HuKuiBio
Commissioned manufacturing of medical devices, namely CMO(OEM), CDMO(ODM)