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Seminar on on the Development Trends and Registration Process for Cosmetic Medical Devices in China Policy Interpretation —— How to Enter the “Fast Track” of Priority Approval？Statistics on the Clinical Trial Data of Quantitative Detection Products of In Vitro Diagnostic Reagents What Data Should be Submitted to Prove the Hemostatic Mechanism of Absorbable Hemostatic Products in China?Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China On What Conditions Can Surgical Instruments Be Exempted From Biological Tests？Regulations on the Reference of Clinical Trial Data in China Is It Possible to Choose A Single-group Target Value Design for Clinical Trials of Intracranial Drug-coated Balloon Dilatation Catheters？What are the Requirements for Anticoagulants Used in Clinical Trials of In Vitro Diagnostic Reagents?About the Measurement Function in the Medical Device Software, What Issues Should be Concerned About in the Registration Application Data?Guideline on Market Access for Medical Device in China Precautions and Registration Preparations for Radio Frequency Beauty Products Transferred to Medical Devices Procedures for handling adverse events in clinical trials of medical devices Common Technical Issues of Active Medical Device 3 Common Technical Issues of Active Medical Device 2 Analysis of Flight Inspection on Unqualified Medical Devices Common Technical Issues of Active Medical Device Ligation clip (closed clip) registration case analysis The Essence of Newly Revised “Regulations on the Supervision and Administration of Medical Devices”What is the Medical Device Master File Registration System 【NMPA】Announcement on the Registration Items of the Master File of Medical Devices (No. 36 of 2021)Approved and Registered Medical Device overview in January 2021 【CMDE】Introduction of Medical Device Registration Process 【CMDE】Product Technical Requirements and Registration Testing 【CMDE】Medical Device Registration System 2020 Medical Device Registration Work Report Free Webinar: Overview of Chinese Medical Device Regulations 【Free Webinar】Overview of Chinese Medical Device Regulations - Korea Branch Registration Application of Software Medical Device Free Webinar: Overview and Update of Medical Device Clinical Trial Regulations in 2020 Free Webinar: An Overview of China and Europe Medical Device Regulations with Case Study on Surgical Mask 【NMPA】The results of Sampling Inspection of Medical Device Supervision (No.5)The Regulations on Supervision and Administration of Medical Devices (Revised Draft) was adopted Technical Guidelines of use IVD overseas Clinical Trial Data (draft for comment)【NMPA】Announcement on Approval of 73 Medical Device in October NMPA - An Interpretation on Drug and Medical Device Combination Product 【NMPA】 Analysis of the Related Matters about Imported Medical Devices Manufacturing in China (Announcement NO.40 2020)CFDA, NMPA Guideline for Medical Device Registration in China 【NMPA】Announcement on the Production of Imported Medical Devices in China related matters (NO.104, 2020)NMPA, Announcement on Imported Certificated Medical Devices product Transfer to Domestic Production in China The Revision of Class III Medical Devices that Need to be Approved for Clinical Trial ( revised in 2020)[NMPA] New and Revised Catalogue of Medical Devices Exempted from Clinical Trials (Draft for Comment)The Class III Medical Devices that Need to Be Approved for Clinical Trials (Revised in 2020, Draft for Comments)[Clinical Trial] Superiority Trial of Medical Device Clinical Trial Design [Clinical Trial] Non-inferiority Trial of Medical Device Clinical Trial [Clinical Trial] Factors Affecting the Estimation of the Sample Size of Clinical Trials of Medical Devices Medical Device Overseas Clinical Trial Data for Registration in China [NMPA] The Content Adjustment of the "Medical Devices Classification Catalogue"[UDI Database] Medical Device Unique Identification Database Is Open to the Public [Important] How to Check the Registration Information of Anti-epidemic Medical Device Products China's First Medical Device Approved for Marketing by Using Domestic Clinical Real-World Data

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About

【NMPA】7 New Registration Technical Review Guidelines

Mar 10, 2020 from CIRS by Yolanda

On March 5, 2020, the NMPA issued

- Guidelines for the Technical Review of Registration of Colloidal Gold Immunochromatographic Analyzers

- Guidelines for the Technical Review of Registration of Follicle-stimulating Hormone Detection Reagents

- Guidelines for the Technical Review of Registration of Creatinine Detection Reagents

- Guidelines for the Technical Review of Registration of Antinuclear Antibody Detection Reagents

- Guidelines for the Technical Review of Registration of Antithyroid Peroxidase Antibody Testing Reagents

- Guidelines for the Technical Review of Registration of Glycated Albumin Assay Reagents and

- Guidelines for the Technical Review of the Registration of Total Bile Acid Determination Reagents

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.

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md@cirs-group.com