Passive medical devices
2021-03-25
Registration
in China
All categories
Classic Case
Product Testing Agent Service
- Categories:Other
- Time of issue:2021-04-07 14:27:06
- Views:0
Description:
Information
Medical device testing needs to be processed by one or several of the NMPA-approved testing centers. They conduct compliance verification on the performance indicators of the product samples and on the technical specification and labels in accordance with the product technical requirements prepared by the company itself.
For Class II and Class III medical device products, a test report must be obtained from an NMPA-approved testing center before registration, and the test report shall be submitted to NMPA for review as one of the main documents in the registration application. For Class I medical devices, self-test reports or third-party test reports can be submitted when filing.
➣ Service Scale
1.Develop test plan and preliminary plan
2.Determine of test items/products and apply for applicable exemptions
3.Assist in contacting a qualified laboratory/testing center and coordinate the testing process
4.Assist in drafting, formulating and reviewing product technical requirements
5.Assist in determining the sample size and sample delivery process service
6.Track testing progress
7.Communicate with testing inspectors on technical issues
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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.