Following Fujian, Jiangxi, Shanghai, Hainan, Shandong and Inner Mongolia, Beijing charges for registration of Class II medical devices. On June 27, BFDA issued Implementation Rules on Drugs & Medical Devices Registration Fees in Beijing (Interim) (hereinafter referred to as Implementation Rules). In accordance with the document, the initial registration fee for class II medical devices is CNY 93,900, registration alteration fee CNY 39,300, and registration renewal fee CNY 39,000. Where the Implementation Rules is applied to registration fee of In Vitro diagnostic reagents managed as medical devices. Relevant charging rates shall come into force from July 1, 2016. Applicant should pay registration fee within 5 working days upon reception of Payment Notice for Administrative Licensing Items accordingly, or the registration procedure shall be terminated automatically.
So far, among the 7 provinces issued charging rates, the fee in Beijing and Shanghai is the highest.
Items |
Class II Medical Devices |
Time of issuance |
|||
Initial registration fee |
Registration alteration fee |
Registration renewal fee (once every 5 years) |
|||
Charging rate |
Fujian |
82,400 |
34,500 |
34,200 |
2015.11.19 |
Jiangxi |
78,100 |
32,700 |
32,400 |
2015.12.17 |
|
Shanghai |
93,900 |
39,300 |
39,000 |
2016.1.29 |
|
Hainan |
83,000 |
34,400 |
34,100 |
2016.3.1 |
|
Shandong |
82,200 |
34,400 |
34,100 |
2016.3.15 |
|
Inner Mongolia |
72,100 |
30,200 |
29,900 |
2016.5.11 |
|
Beijing |
93,900 |
39,300 |
39,000 |
2016.6.27 |
|
Prepared by: Chinese Medical Devices (ID: Medchina) |