Showing 1–16 of 29 results
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ADMINISTRATIVE MEASURES FOR DRUGS IMPORTATION (Order No. 4)
$350.00 $300.00
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ADMINISTRATIVE MEASURES FOR DRUGS REGISTRATION – (Order No. 28)
$350.00 $300.00
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Administrative Measures for the Communication with CDE During Drug R&D and Technical Evaluation, Order No.48,2020
$200.00 $100.00
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Announcement of the State of Food Drug Administration on the Issuance of Working Procedures for Review of Breakthrough Therapies No.82, 2020
$200.00 $100.00
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Announcement on Approval of Active Pharmaceutical Ingredients (API), Pharmaceutical Excipients and Pharmaceutical Packaging Materials for Drug Products No.146, November 30, 2017
$100.00
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Announcement on Further Improving Related Issues Concerning Drug Evaluation, Approval and Supervision (DMF for API, Pharmaceutical Packaging Materials and Excipients)(No. 56 of 2019), July 15, 2019
$100.00
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Announcement on Record Filling of Medical Device Master Files
$50.00
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C-Reactive Protein Assay Kit Registration Technical Review Guideline
$100.00
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Decree No. 1 – Annex 3: Guideline on Medical Device Adverse Event Monitoring Scope (Draft)
$200.00
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Decree No. 1 – Annex 7: Guideline on Focus Points when Monitoring Medical Device Adverse Events (Draft)
$150.00
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Decree No. 101: Regulations for The Administration of Overseas Inspection of Pharmaceutical & Medical Devices
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Decree No. 131: Announcement on Using Chinese Name for Registrant or File Submitter of Imported Medical Devices
$100.00
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Decree NO. 6: Guideline on the Design of Clinical Trials for Medical Devices
$150.00
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Decree No. 6: Regulation on Instructions for Use and Labels of Medical Devices
$200.00
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DECREE NO. 7 : Measures for Supervision and Administration of Medical Device Production
$50.00
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Decree No. 83: Innovative Medical Device Special Approval Procedure
$200.00
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