- Time of issue:2021-04-07 14:25:33
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.
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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