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Menu
Home
About
About Us
Our Team
Testimonials
Regulatory
RA Strategy
NMPA Classification
Product Registration
QMS, PMS
In-country Representation
IVD & CDx
SaMD
CRO
Clinical Trial Services
Overseas Clinical Data
Clinical Evaluation Report (CER)
Real World Data (RWD)
Hainan Real-World Data/Study
Commercialization
Resources
Regulatory Intelligence Portal
NMPA (CFDA) Regulations
NMPA (CFDA) Newsletters
Brochures
White Papers
Recorded Webinars
Events
FAQs
Blog
Contact
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NMPA Medical Device Registration & Clinical Trial Process
399.40 KB
466 downloads
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Operation Specification for Record Filing of Medical Device Master Files
0.00 KB
47 downloads
...
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Record Filing Requirement of Medical Device Master Files
0.00 KB
47 downloads
...
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Guideline for Record Filing of Medical Device Master Files (Draft)
0.00 KB
36 downloads
...
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Announcement on Record Filling of Medical Device Master Files
0.00 KB
24 downloads
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Innovation Device Approval Procedure
0.00 KB
61 downloads
...
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Unique Device Identification (UDI) Implementation Plan (draft)
0.00 KB
70 downloads
...
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Using Chinese Name for Registrant or File Submitter of Imported Medical Devices
0.00 KB
44 downloads
...
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Regulation on Instructions for Use and Labels of Medical Devices
0.00 KB
90 downloads
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