Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 3 of 4)

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1. The Review and Approval of Medical Device Registration Applications

In 2016, China Food and Drug Administration completed a total of 9336 technical reviews of medical device registration applications. Compared with 2015, the number was increased by 0.25%. Among them, there were 2427 first–time registration, 5276 renewal registration and 1633 licensing change registration. As of the end of 2016, there were a total of 5598 applications in the state of review, among them, 2247 applications were in the state of pending supplementary after the note of supplementary materials was issued.

In 2016, China Food and Drug Administration approved a total of 8653 applications for medical device registration, renewal of registration and licensing changes. Compared with 2015, the total approval number was increased by 14.9%.

In 2016, a total of 338 medical device registration applications were denied by China Food and Drug Administration, and 310 applications were withdrawn by enterprises voluntarily. The approval situation of medical device registration in recent four years is shown as Figure 5.

Figure 5. The registration situation from the year 2013 to 2016

(a) The overall situation

In 2016, a total of 2902  Class Ⅲ domestic medical device registration applications were approved. Compared with 2015, the total approval number was increased by 6%. And a total of 5751 imported medical device registration applications were approved. Compared with 2015, the total approval number was increased by 20%.

Classified by the kinds of registration, there were 5506 medical device registration applications and 314 in vitro diagnostic reagent registration applications.  The ratio of them was around 7:4.

Classified by the types of registration, there were 1966 first-time registration applications which accounted for 23% of all registration applications, 5221 renewal registration applications which accounted for 60% of all registration applications, and 1466 licensing change applications which accounted for 17% of all registration applications. The proportion of the registration types is shown in Figure 6.

Figure 6. Pie chart of registration types in 2016

(b) By Category

2. Review and approval situation of imported class Ⅱ medical device

In 2016, a total of 3083  imported class Ⅱ medical devices registration applications were accepted. Among them, there were 1535 medical device registration applications and 1548 in vitro diagnostic reagent registration applications.

Classified by the types of registration, there were 444 first-time registration applications which accounted for 14% of all imported class Ⅱ registration applications, 2077 renewal registration applications which accounted for 68% of all registration applications, 562  licensing change applications which accounted for 18% of all registration applications. The proportion of the registration types is shown in Figure 8.

Figure 8. Distribution chart of imported class Ⅱ registration application types

3. The review and approval situation of imported class Ⅲ registration applications

In 2016, a total of 2668 imported class Ⅲ medical devices registration applications were accepted. Among them, there were 2255 medical device registration applications, and 413 in vitro diagnostic reagent registration applications.

Classified by the types of registration, there were 593  first-time registration applications which accounted for 22% of all imported class Ⅱ registration applications, 1634  renewal registration applications which accounted for 61% of all registration applications, 441  licensing change applications which accounted for 17% of all registration applications. The distribution of the registration types is shown in Figure 9.

Figure 9. Distribution chart of imported class Ⅲ registration application types

(c)  The monthly review and approval situation of first-time registration applications

China Food and Drug Administration approved a total of 1966 medical devices first-time registration in 2016. The monthly review and approval situation is shown in Figure 10.

Figure 10. The data chart of monthly review and approval of medical device first-time registration application

(d)  The analysis of detailed approval types

Checking from the data of registration, the in vitro diagnostic reagents occupied a large proportion in the registered products. Among them, the number of imported in vitro diagnostic reagents accounted for 33% of the total number of registration.

In addition to in vitro diagnostic reagents, the registered imported medical devices in 2016 involved a total of 39 subdirectories in the “Medical Device Classification Directory”.

The top five imported medical devices included: implanted materials and artificial organs, medical optic wares, instruments and endoscopic equipment, medical electronic equipment, medical polymer materials and products, operating room, emergency room, equipment and devices of diagnosis and treatment room.

Compared with 2015, the ranking of same implanted materials and artificial organs products raised from the second to the first, while the ranking of operating room, emergency room, equipment and devices of diagnosis and treatment room as well as dental materials entered top five.

Figure 12. Ranking chart of imported medical device registration types

(e)   The analysis to countries of origin of imported medical devices

In 2016, the registration number of medical devices made in the United States, Germany, Japan, the United Kingdom and South Korea occupied top five in China, which was same with the number in 2015, accounted for 73% of the total imported products registration in 2016.

Figure 13. The ranking chart of countries of origin of imported medical devices

This report is provided by China Med Device, LLC. Please stay tuned for the last part of this CFDA annual report.


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.

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