Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 2 of 4)

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 1 of 4)
August 27, 2017
Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 3 of 4)
August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 2 of 4)

B. The Acceptance Of Medical Device Registration Application

In 2016, China Food and Drug Administration received a total of 8920 applications for medical device registration, renewal of registration and licensing changes. Compared to 2015, the acceptance number was decreased by 5.1%.

(a)   The overall situation

In 2016, a total of 3007 Class Ⅲ domestic and 5913 imported medical device registration applications were accepted.

Classified by the kinds of registration, there were 5920 medical device registration applications and 3000 in vitro diagnostic reagent registration applications.

Classified by the types of registration, there were 1612 first-time registration applications which accounted for 18% of all registration applications, 5402 renewal registration applications which accounted for 61% of all registration applications, and 1906 licensing change applications which accounted for 21% of all registration applications. The proportion of the registration types is shown in Figure 1.

Figure 1. Pie chart of registration types

(b)  The situations of imported medical devices

1. The acceptance situation of imported classⅡ registration applications

In 2016, a total of 3095 imported class Ⅱ medical devices registration were accepted. Compared with 2015, the number was increased by 2%. Among them, there were 1690 medical device registration applications and 1405 in vitro diagnostic reagent registration applications.

Classified by the types of registration, there were 449 first-time registration applications which accounted for 15% of all imported class Ⅱ registration applications, 2021  renewal registration application which accounted for 65% of all registration applications, 625  licensing change applications which accounted for 20% of all registration applications. The proportion of the registration types is shown in Figure 3.

Figure 3. Distribution chart of imported class Ⅱ registration application types

2. The acceptance situation of imported class Ⅲ registration applications

In 2016, a total of 2818 imported class Ⅲ medical devices registration were accepted. Compared to 2015, the number increased by 15%. Among them, there were 2331 medical device registration application and 487 in vitro diagnostic reagent registration application.

Classified by the types of registration, there were 229 first-time registration applications which accounted for 11% of all imported class Ⅲ registration applications, 1759 renewal registration application which accounted for 63% of all registration applications, 760  licensing change applications which accounted for 16% of all registration applications. The distribution of the registration types is shown in Figure 4.

Figure 4. Distribution chart of imported class Ⅲ registration application types

 

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


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