Black week of medical device

We (Easychinapprov and   Medkaizhen) want to have attention of manufacturer of medical device in black week. So than our client new and old, we will have an extended regulatory black month till Dec. 13 in 2024.

Using “𝐄𝐚𝐬𝐲𝐛𝐥𝐚𝐜𝐤” as cocde to fill the form, we will come back to you with our sales offer:

·        Free Template (only one)

·        Free consulting (first 30 min free in a meeting)

·        Project, workshops, training depending on whole cost 10-30 %

·        Prof. templates 30-50%

·        E-learning of regulatory affairs 20-30%

Form

100% Free, one gift per one inquiry

• Gap analysis for Chinese market after tests
• Gap analysis for international market after test (ask code)
• Gap analysis from MDR or FDA to Chinese and other market (ask code)
• Gap analysis of type testing after test (ask code)
• Gap analysis of international quality management (ask code)       
• Free consulting in term s of 30 min meeting
• White paper (starterkit for Chinese market, starterkit for startups)

For chinese market

• Template of Essential of Principles of Safety and Performance
• Table of content of technical documentation
• Consolidated regulations in 2024

For International market

• Checklist of international representative or distributor
• Roadmap of international registration
• 医疗器械的出海差异分析

Gifted black deal

1. Chose ME first

Any kind of project from design, testing, quality management and regulatory affairs can be chosen.

·        Registration of medical device in subject market

·        Outsourced testing

·        Workshop (from FDA to other markets, from MDR to other market, just for startups)

·        Training (regulatory LEAN, regulatory intelligence, market access with KPI)

·        One year Regulatory affairs eLearning

·        Template (international change assessment, international vigilance)

2. Gift following

This can be gifted if you chose at least one service in tem 1:

• Working Instruction of Type Testing. In China
• Check list of Chinese Labelling with example
• Product technical requirement matrix with example in China
• Table of content of technical documentation with requirement in China
• Template of Chinese adverse event report
• Template of periodic risk evaluation report in China
• White paper of Chinese GMP
• Ready for overseas inspection
• Trace your registration with Chinese EP

…

…

• International change template (only one)
• Matrix to monitor international registration
• Template of marketing history
• Template of Taiwan registration (only one)
• Template of ASEAN template registration (only one)
• Testing plan, report and evaluation
• Template of three inspections in production
• Template of shelf life test
• White paper to influence international registration

…

…

Other services

We have also following services which would be chosen with 10%-30% sales depending on size of proposal.

For Chinese market

Registration of MD and IVD

Post market service

Change assessment

Regulatory requirement monitoring

For international market

International RA-project

Interim manager

Legal representative