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ADMINISTRATIVE MEASURES FOR DRUGS IMPORTATION (Order No. 4)
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ADMINISTRATIVE MEASURES FOR DRUGS REGISTRATION – (Order No. 28)
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Administrative Measures for the Communication with CDE During Drug R&D and Technical Evaluation, Order No.48,2020
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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
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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
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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
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Announcement on Record Filling of Medical Device Master Files
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C-Reactive Protein Assay Kit Registration Technical Review Guideline
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Decree No. 1 – Annex 3: Guideline on Medical Device Adverse Event Monitoring Scope (Draft)
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Decree No. 1 – Annex 7: Guideline on Focus Points when Monitoring Medical Device Adverse Events (Draft)
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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
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Decree NO. 6: Guideline on the Design of Clinical Trials for Medical Devices
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Decree No. 6: Regulation on Instructions for Use and Labels of Medical Devices
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DECREE NO. 7 : Measures for Supervision and Administration of Medical Device Production
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Decree No. 83: Innovative Medical Device Special Approval Procedure
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ADMINISTRATIVE MEASURES FOR DRUGS IMPORTATION (Order No. 4)

ADMINISTRATIVE MEASURES FOR DRUGS REGISTRATION – (Order No. 28)

Administrative Measures for the Communication with CDE During Drug R&D and Technical Evaluation, Order No.48,2020

Announcement of the State of Food Drug Administration on the Issuance of Working Procedures for Review of Breakthrough Therapies No.82, 2020

Announcement on Approval of Active Pharmaceutical Ingredients (API), Pharmaceutical Excipients and Pharmaceutical Packaging Materials for Drug Products No.146, November 30, 2017

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

Announcement on Record Filling of Medical Device Master Files

C-Reactive Protein Assay Kit Registration Technical Review Guideline

Decree No. 1 – Annex 3: Guideline on Medical Device Adverse Event Monitoring Scope (Draft)

Decree No. 1 – Annex 7: Guideline on Focus Points when Monitoring Medical Device Adverse Events (Draft)

Decree No. 101: Regulations for The Administration of Overseas Inspection of Pharmaceutical & Medical Devices

Decree No. 131: Announcement on Using Chinese Name for Registrant or File Submitter of Imported Medical Devices

Decree NO. 6: Guideline on the Design of Clinical Trials for Medical Devices

Decree No. 6: Regulation on Instructions for Use and Labels of Medical Devices

DECREE NO. 7 : Measures for Supervision and Administration of Medical Device Production

Decree No. 83: Innovative Medical Device Special Approval Procedure

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