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Beijing Haimiao Pharmaceutical Technology Co., Ltd
Adress:Room 520,Huilongguan Town, Changping District, Beijing,China(102208)
Phone: 8610-62715466,8610-62715478
Fax: 010-62715478
Beijing Haimiao Pharmaceutical Technology Co., Ltd(U.S BRANCH)
Adress:250 e gun hill road, apt 3i, bronx, NY 10467
Phone: 001 646 4653085
Fax: 001 267 3163911

IVD’s registration

      According to 《Provisions for the Registration of In Vitro Diagnostic Reagents  (draft)》 (No.229 of SFDA )(2007-04-19),all IVD reagents including class I,II,III and imported IVDs should be registered in sFDA. Class I should be registered in municipal sFDA, class II should be registered in provincial sFDA, class III and imported IVDs should be registered in national sFDA. class II,III and imported IVDs should carry out clinical trials.We can provide “serve first, pay second” style regarding to the good credit company! Flow chart for IVDs registration is as followed.

1 Confirm applicant’s requirements.
2 Draft products’ standard.
3 Contact with testing institute for products’ testing.
4 Carry out IVD’s clinical trial.
5 File all application materials.
6 Submit all data to local or national sFDA for evaluation.
7 Follow evaluation and then obtained Registration Certificate.

Address:Room 520,Huilongguan Town, Changping District, Beijing
Phone :010-62715466      010-62715478      Fax:010-62715478      E-mail:hm-cro@hm-cro.com
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