Passive medical devices
2021-03-25
Registration
in China
All categories
Classic Case
Agent service
- Categories:Import
- Time of issue:2021-04-07 14:25:33
- Views:0
Description:
Information
According to the Administrative Measures for Medical Device Registration, in addition to handling medical device registration or filing matters, an agent shall also bear the following responsibilities:
a)Liaison with the corresponding drug regulatory authority, overseas applicants or filing persons;
b)Faithfully and accurately communicate the relevant laws, regulations and technical requirements to the applicant or filing person;
c)Collect information on adverse events of already go-public medical devices and feed them back to overseas registrants or filing persons, and report to the relevant food and drug regulatory authority;
d)Coordinate the product recall of medical devices after they go public, and report to the relevant regulatory authorities;
e)Other joint and several liabilities related to product quality and after-sales service.
➣Service Scale
1.Liaise and coordinate domestic supervision and management authorities
2.Keep our clients informed on relevant regulations and standards
3.Produce annual self-examination report
4.Monitor adverse event and writing the report
5.Report the recalls to the NMPA
6.Keep paying attention to the situation of product sales in China
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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.