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In order to strengthen the management of IVD enterprises and make a standard for IVD reagent enterprise , National Bureau has drawn up the Acceptance Criteria of IVD Reagent and Acceptance Criteria of In Vitro Diagnostics （IVD） Reagent Registration Procedures.
Each province, district or city which meets the Acceptance Criteria of IVD Reagent and Acceptance Criteria of In Vitro Diagnostics （IVD） Reagent Registration Procedures, can be received Drug Supply Certificate and Medical Device Distribution Business License, whose line of business is only for IVD reagent.
If IVD reagent enterprises mentioned above want to expand its line of business, it has to apply for Drug Supply Certificate or Medical Device Distribution Business License again. Enterprises must do business on the base of Good Supply Practice for Pharmaceutical Products (GSP).
Osmunda’s professional advisor and consultant team, with experiences of senior managerial position of national and international medical device manufacturers and professional background of doing long-term registration of medical devices, enjoyed a long and friendly relationship with national and international certification bodies, national medical devices testing organizations.
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