Passive medical devices
2021-03-25
Registration
in China
All categories
Classic Case
Innovative IVD Product Special Examination & Approval
- Categories:Other
- Time of issue:2021-06-09 15:48:30
- Views:0
Description:
Information
IVDs that meet the following conditions are prioritized for technical examination and approval:
a)Through technological innovation activities, the applicant has legally obtained patent rights for product core technology inventions in China, or obtained invention patent rights or the right to use in China through transferring;
b)The product's main working principle/mechanism is a domestic initiative in China. The performance or safety of the product is fundamentally improved compare with similar products. It is at the globally state-of -the-art level in technology and has significant clinical value;
c)The applicant has already completed the primary research of the product and has a basic finalized product. The research process must be true and controlled, and the research data is complete and traceable.
➣ Required Documents：
1.Application form
2.Applicant's corporate legal personality certification documents
3.Product intellectual property rights and certification documents
4.Summary of product development process and results
5.Product technical documents
6.Proof of product innovation
7.Product safety risk management report
8.Product manual (sample)
9.Other supportive documents
➣ NMPA administrative fee：
There is no charge for applying innovative IVD special examination & approval. The approval or disapproval of the innovative product does not affect the initial registration fees and normal registration application of Class II and Class III products.
➣ Estimated Timeline：around 60 workdays.
Scan the QR code to read on your phone
Telephones
info@crcs.com.cn
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
客户留言
描述：
Beijing Medical & Care Co. Ltd.