Beijing Charges for Registration of Medical Devices, Initial Registration Fee: CNY 93,900

  • 2016-06-29

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)

Search