In 2021,NMPA approved 11,314 items of initial registration, renewal registration and change registration of medical devices, an increase of 14.9% compared with 2020.
Imported Class II Medical Devices and IVDs
NMPA approved 3,649 imported Class II medical devices and IVDs, including 2,132 medical devices and 1,517 in vitro diagnostic reagents, covering initial registration, renewal and modifications. Imported Class III Medical Devices and IVDs
NMPA approved 3,069 imported Class III medical devices and IVDs, including 2,633 medical devices and 436 in vitro diagnostic reagents, covering initial registration, renewal and modifications. NMPA Approval of Initial Registration In 2021, NMPA approved the initial registrations of 1,710 medical devices.
Analysis on Approved Categories for Imported Medical Devices
The top five imported medical devices are medical imaging devices, passive implant devices, dental devices, neurological and cardiovascular surgical devices and ophthalmic devices, the same as in 2020.
Analysis on the Home Countries of Imported Medical Devices In 2021, the approved medical devices are from 27 countries (regions). Among them, medical devices from the United States, Germany, Japan, South Korea and Switzerland ranked among the top five for the initial registration of imported medical devices in China, accounting for about 72.5%, basically the same as that in 2020.
In 2021, NMPA accepted 12,255 applications for initial registration, renewal registration and change registration of medical devices, an increase of 15.8% compared with 2020. Overall situation NMPA accepted 5,338 domestic class III medical device registration applications and 6,917 imported medical device registration applications.
According to the registration category, there are 8,540 applications for medical devices and 3,715 applications for in vitro diagnostic reagents.
According to the registration form, there are 2,750 initial registration applications, accounting for 22.4% of all medical device registration applications; 5,875 applications for renewal registration, accounting for 48% of all medical device registration applications; 3,630 applications for change registration, accounting for 29.6% of all medical device registration applications.
The territory of China engaged in the field of medical devices related to production and business activities must be subject to the supervision of drug supervision and management departments at all levels. The primary basis for the implementation of regulatory actions at all levels of government is the State Council’s “Regulations on Supervision and Administration of Medical Devices” and the regulations and documents issued by the NMPA and local governments at all levels. Various regulations and documents on the registration and filing of medical devices, research, and development, production, business sales, transport and use, adverse events, recall system, etc., have made detailed provisions and for all types of products supporting the relevant technical standards to achieve the supervision of the whole life cycle of the product. At all levels of various types of regulatory instruments, the quality of medical device products sampling inspection, especially by the NMPA unified deployment, the provinces (including autonomous regions, municipalities directly under the Central Government, the Corps, the same below) level drug regulatory departments directly implement the national medical device quality sampling inspection work (hereinafter referred to as “national sampling”), is the highest level of administrative supervision means from government directly to the enterprise with the most importance.
On February 21, 2002, the national NMPA issued the “2022 National Medical Device Sampling and Inspection Program”, which formally deployed the “National Sampling” work to all provincial NMPA departments. In the following, we will explain the basic concepts, organizational procedures, working methods, and general rules of “national sampling” to our customers and combine them with our long-standing service to our customers. We will also propose corresponding response strategies for reference, taking into account our long experience in serving customers to deal with “national sampling.”
BradyKnows QA team has helped many overseas manufacturers for China NMPA audit and other QMS/PMS activities. We provide more detailed interpretations from below aspects.
I. What is “national sampling” (basic concept)
II “National Sampling” is how to organize and implement (implementation procedures)
III The “national sampling” what to check (the main content)
IV How to be sampled (response strategy)
V. What will happen if you are not sampled (other cases)
Since the promulgation and implementation of the Measures for the Administration of Medical Device Clinical Trial Institutions Conditions and Filing on January 1, 2018, a total of 1,074 institutions in 31 provinces and regions have completed the filing of medical device clinical trial institutions.
Once filing as clinical trial institutions completed, the hospitals can conduct clinical trial for medical devices in China.
Among them, Guangdong Province, Shandong Province, Jiangsu Province, Beijing and Shanghai rank as the top five with most clinical trial sites in China.
BradyKnows has done dedicated workshop for overseas clients to understand more about China GCP, clinical study operation and audits. Please feel free to contact us for any questions about clinical study in China via info@bradyknowsmedical.com
Date: Wednesday, Feb 23, 2022, 8:00-9:00 AM Pacific Time (US and Canada)
Clinical evaluation is mandatory for getting market approval in China for Class II or III medical devices unless the device is clinically exempted. With the implementation of Order 739, the newly revised fundamental regulation of medical devices, clinical evaluation can be achieved by different pathways including the clinical evidence from equivalent or comparable devices, clinical trials in China or overseas, or multi-region clinical trials. The preparation of a solid and convincing CER with robust clinical evidence plays a significant role in the regulatory decision-making process. In this webinar, our speaker Dr. Mike Zhu will discuss the basis and rules of developing a China CER, how to select the least burdensome clinical pathway, tips, and pitfalls in preparing a China CER, and finally introduce the differences between China CER vs. EU CER to figure out how much information you could leverage from EU CER (if it exists). Participants will be able to develop strategic thinking when making decisions for the clinical path to support China submissions and more efficiently prepare a convincing China CER.
Agenda:
Major changes to clinical evaluation under Order 739
Have you chosen the best clinical pathway to register your products in China?
How to prepare a convincing China CER?
How to get your CER accepted for review?
Good practice as well as pitfalls in preparing a China CER
Major differences between a China CER and an EU CER
