Contact us. We will provide password to download premium material besides free downloads.
Template, procedure, working instrucktion, checklist
Either good example, cheklist or template of any submission documentation or white paper with case analysis, we want to enable the Chinese registration on your own.
NMPA starter kits
Type testing briefing
Acceptance checklist of submission dossiers (eRPS)
MDR impact in Chinese registration
Template
Template of chinese adverse event, PSUR, annual QM report
Whitepaper
Whitepaper: registration of standalone software in China
Whitepaper: No-GO with Chinese distributor!
Whitepaper: how to find investors to enter China?
Adverse event reporting
99 EUR
It can be a quick reporting issue using our template and communicaiton assignment.
Template of GB/T 25000.51-2016
Systems and software engineering -- Systems and software Quality Requirements and Evaluation (SQuaRE) -- Part 51: Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing
99 EUR
It is not worthy to test your software with a lab. Use our template.
99 EUR
Make the key registration chapter compliant and elegant
Design change assessment tool
199 EUR
Use our assessment of product change before, during and after product registration in China
Chinese process
Feasibility of Chinese registration
Cheklist of technical documentation
Timeline of registration milestone
299 EUR
Post market
Procedure of post market surveillance
Checklist of adverse event
Checklist of periodic risk assessment report
Checklist of annual quality system report
299 EUR
International registration
Procedure of registration
Checklist of registration
199 EUR
Checklist for Chinese IFU and Label
99 UER
Have a plan of Chinese labelling from beginning of user need
Contact
Frankfurt, Stuttgart Germany
Sun Dong An Plaza, No. 138
Beijing China
info@easychinapprov.com
0049-17638379004
Chinese
Service
Service in Europe
Training (remote and in-house)
Proposal
Knowlege
Regulatory news
Sale (up to 50 %):
Template of registration
On-Demand Workshops
Legal notice
Newsletter
E-Learning "MyComplinace"
Learning Chinese regulation and global regulatory affairs
Participation possible any time.
Discount 19%
Article:
Overseas inspecion starts again
Testing beyond and for registration
Significant changes of medical device in China, EU, MDSAP countries
Meet us in next conference:
May, 2024 in France, ORTHOMANUFACTURE
Global compliance and training
