Service

According to Administrative Measures for IVD Reagent Registration, in addition to registration or filing, we also:

•  Contact the corresponding food and drug administrations, foreign applicants or filing entities;

•  Faithfully and accurately convey relevant regulatory and technical requirements to the applicant or the filing entity;

•  Collect post-marketing AEs of IVD reagents, and report them to the foreign registration or filing applicant as well as corresponding food and drug administrations;

•  Coordinate the recall of marketed IVD reagents and report to corresponding food and drug administrations;

•   Undertake other joint liabilities involving in product quality and after-sales services.

Service contents

•  Contact and coordinate competent regulatory authorities in China

•  Convey relevant regulations and standards

•  Annual self-inspection reports

•  AE monitoring and reporting

•  Report the recall to competent medical products administrations

•  Sales condition in China and tracing

•  Computer information management system