Guide a US manufacturer with 5 global sites to comply with China GMP
Objectives
- Determine and identify areas of deviations for its 20+ class III products.
- Provide project management and training for different sites to integrate China GMP requirements in its global QMS.
Key Activities
- Reviewed and assessed 20+ class III products China NMPA technical files and IFUs and their associated DHFs. Provided summary of deviation findings for each product.
- Reviewed key GMP processes in 5 global manufacturing sites
Recommended Areas of Improvement
- Recommended implementation areas to be compliant with China GMP in areas such as people/resources, documentation, inspections, storage of materials, cleanroom level, supplier audit requirements etc.
- Developed easy to follow priority and detail tracker matrix for the 20+ products
This case study exemplifies our commitment to helping clients navigate complex regulatory environments and achieve tangible success. At China Med Device, LLC, we take pride in being your trusted partner on the journey to successful market access in China. For more information regarding the Made-in-China policy, please click HERE.
Guangdong is a leading province to encourage imported devices to localize there with a simplified registration process. Click HERE for more information
For our recorded webinar on NMPA Key Updates on GMP/QMS, please click HERE
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Automotive / EVs, Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- ChartPrime. Elevate your Trading Game with ChartPrime. Access Here.
- BlockOffsets. Modernizing Environmental Offset Ownership. Access Here.
- Source: https://chinameddevice.com/china-gmp/
- :is
- a
- access
- Achieve
- and
- areas
- assessed
- associated
- audit
- BE
- being
- case
- case study
- China
- class
- click
- clients
- commitment
- complex
- compliant
- comply
- detail
- deviation
- device
- Devices
- different
- documentation
- easy
- encourage
- environments
- etc
- exemplifies
- Files
- findings
- follow
- For
- Global
- helping
- HTTPS
- identify
- iii
- implementation
- in
- information
- integrate
- ITS
- journey
- Key
- leading
- Level
- LLC
- management
- Manufacturer
- Market
- materials
- Matrix
- more
- Navigate
- of
- on
- our
- partner
- plato
- Plato Data Intelligence
- PlatoData
- please
- policy
- pride
- priority
- process
- processes
- Product
- Products
- project
- project management
- provided
- recorded
- regarding
- Registration
- regulatory
- Requirements
- simplified
- Sites
- storage
- Study
- success
- successful
- such
- SUMMARY
- supplier
- support
- Take
- Technical
- The
- their
- There.
- to
- Training
- trusted
- trusted partner
- Updates
- us
- we
- webinar
- with
- Your
- zephyrnet
More from China Med Device
Software Company Defects Found in Unannounced Inspection
Source Node: 2069927
Time Stamp: Apr 20, 2023
Error Correction Matters Added into Electronic Filing System
Source Node: 2068833
Time Stamp: Apr 20, 2023
Guideline on Human Factors Design Asks Second Round Feedback
Source Node: 2324793
Time Stamp: Oct 13, 2023
How to Get NMPA Approval for RF Aesthetic Devices? Final Guideline Issued
Source Node: 2071298
Time Stamp: Apr 24, 2023
