Your position:
Homepage
/
Class III IVD Product Registration
Registration in China

Registration

in China

All categories

Classic Case

IVDs

2021-03-25

Class III IVD Product Registration

  • Categories:Import
  • Time of issue:2021-06-09 15:42:58
  • Views:0
Description:
Description:
Information

Class III IVDs have higher risks and need special measures to strictly control and manage to ensure their safety and effectiveness. Both domestic and overseas IVD manufacturers need to register with the NMPA.

 

➣ Required Documents:

 1.Proof documents

 2.List of basic requirements for the safety and effectiveness of the product

 3.Summary information

 4.Research materials

 5.Manufacturing information

 6.Clinical evaluation data

 7.Product risk analysis data

 8.Product technical requirements

 9.Product registration inspection report

 10.Sample manual and label

 11.Declaration of conformity

➣ NMPA Administrative Fee

Medical device registration fee standard

Unit: CNY 

Project

Imported

Category III

Initial Registration Fee

308,800

Registration Changing Fee

50,400

Registration Renewal Fee (once per 5 years)

40,800

Note:

 1.Medical device product registration fees are calculated and collected in accordance with the Administrative Measures on the Registration of In Vitro Diagnostic Reagents.

 2.The registration fees for Hong Kong, Macau, and Taiwan medical devices are the same with the registration fees for imported medical devices.

 3.Fees for medical device expedited registration shall be formulated separately.

➣ Estimated Timeline:

 1)Project Establishment

  i.Consideration period, budget estimation, proposal and contract setup, about 1 month

 2)Document Preparation before NMPA Acceptance

  i.Average time cost of product testing: about 6 months.

  ii.Clinical trials cannot be performed concurrently with product testing. Clinical trial time shall be calculated separately and be expected at least 12 months.

  iii.For actuarial calculations, please contact us.

  iv.The preparation of registration application documents can be concurrently prepared with testing or clinical trial.

 3)After NMPA Acceptance

  i.NMPA reviewing time cost: about 10 months (188 work days, 20 work days per month, excluding holidays)

  ii.The time limit for document supplement is 0 to 12 months and the average time period is 6 months. It highly depends on the situation of the documents for primary registration application of the product.

  iii.According to regulations, NMPA going overseas to perform local unannounced inspection is possible.

 4)Total Time Budget

  i.For the new registration of imported Class III medical devices without doing clinical trials, the estimated time cost is around 16 to 24 months.

  ii.For the new registration of imported Class III medical devices with clinical trials, the estimated time cost is around 36 months (including carrying out clinical trial for at least 12 months).

Scan the QR code to read on your phone

CRCS
电话

Telephones

8610-63323201 / 63313868

地址

E-mail

info@crcs.com.cn

邮箱

Address

Room 1009, Tower A, Longqin International Building, No. 168, Guang 'anmenwai Street, Xicheng District, Beijing

Company Introduction

The company specializes in medical device registration, in vitro diagnostic reagents registration, cosmetics agent service company, committed to the NMPA, CE regulation research and product registration and certification service has been more than 17 years.

Contact us

留言应用名称:
客户留言
描述:
Verification code

Beijing Medical & Care Co. Ltd.