• Service
  • Resources
    • Webinars
    • Upcoming Events
    • Documents Download
    • FAQ
    • NMPA Approval Report
  • News
  • CER
  • About
Subscribe

Our Services

Strategy Consulting

  • Market Entry Strategy
  • Regulatory Strategy
  • Clinical Strategy
  • China Localization Strategy
  • Hainan Urgent Use Pathway
  • Innovation Pathway
  • Fast Track Pathway
  • Digital Health Consulting

Registration Affairs

  • Pre-market Registration
  • Modification Registration
  • Renewal Registration
  • Request for Classification
  • Legal Agent Representation
  • NMPA Expert Panel Meeting
  • NMPA Supplemental Notice

Quality Assurance

  • Postmarket Surveillance Compliance (IFU, Label, GSP)
  • Adverse Event Reporting
  • Recall Handling
  • Periodic Risk Evaluation Report
  • Annual QMS Self-Inspection Report
  • NMPA Inspections & Mock-Audit
  • QMS Establishment/Audit/Remediation
  • QA Gap Analysis
  • Factory Audit
  • Unique Device Identifier

Device Testing

  • China Local Type Testing
  • Device Modification Compliance Testing
  • Biocompatibility Testing
  • EMC Testing

Clinical Research Organization (CRO)

  • Clinical Trials/Research
  • Real-World Study
  • China CER & MDR CER
  • Clinical Evaluation Feasibility Assessment

Customized Training

  • China Regulatory Training
  • China QMS Training
  • China GCP Training
  • China Localization Training
  • Periodic Regulatory Updates Training

Other Services

  • Translation
  • Patent & Trademark
  • Distributor Evaluation & Audit
  • KOL Interview/Consultation
  • Investment
  • Global regulatory services
  • Service
  • Resources
    • Resources
    • Webinars
    • Upcoming Events
    • Documents Download
    • FAQ
    • NMPA Approval Report
  • News
  • About
  • CER
  • Subscribe
  • CN
  • US
  • Home
  • Documents Download
  • Guideline & Standard

Documents Download


  • Documents
  • NMPA Regulation
  • Guideline & Standard
  • Clinical Evaluation
  • GMP&QMS
  • AE & Recall
  • Labeling
  • NMPA Drug
  • Cosmetic
  • Other Documents

YYT 1535-2017 Medical Devices For Human In Vitro Assisted Reproductive Technology Biological Evaluation—Human Sperm Survival Assay

Login and Download

YYT 1513-2017 Industry Standard On C-reactive Protein Testing Kit

Login and Download

YYT 1434-2016 Medical Devices For Human In Vitro Assisted Reproductive Technology—In Vitro Mouse Embryo Assay

Login and Download

Technical Review Guidelines For Hydrogel Dressing Registration

Login and Download

Technical Review Guideline On Fetal Chromosome Aneuploidy Test Kit (High-throughput Sequencing Method)

Login and Download

Technical Review Guideline Of Pulse Oximeter Registration 2017

Login and Download

Technical Review Guideline Of Medical Device Software Registration

Login and Download

Technical Review Guideline For Service Life Of Active Medical Device Registration

Login and Download

Technical Review Guideline For Calcuim Phosphrous Silicone Filling Materials

Login and Download

Technical Guideline On Cybersecurity Of Medical Device

Login and Download

Technical Guideline For Medical Device Registration Of Human In Vitro Assisted Reproductive Technology

Login and Download

Technical Guideline For Animal-Derived Medical Device Registration

Login and Download
« Prev...45678...Next »
Twitter Linkedin
United States
Email: info@bradyknowsmedical.com
Phone: +86 18600392020
China
Beijing Office: Room 1501-1502, East Ocean Centre, No. 24 A, Jianguomenwai Avenue, Chaoyang District, Beijing, China
Shanghai Office: Lingang New Zone, China (Shanghai) Pilot Free Trade Zone
Hainan Office: Boao Lecheng pilot zone of international medical tourism, Qionghai City, Hainan Province
Email: info@bradyknowsmedical.com
Phone: +86 18600392020 +86 10 65155991

©2025 Bradynuoen Beijing PharmTech Co Ltd All Rights Reserved.

京ICP备15042665号-7