Market access of Medtec to Chinese Market
We meet online and exchange
A personal meet is always worthy
Classic and solution tailored
We believe that we should firstly know you personally, learn your product and your company. Then we talk about your inquiry in details. Use our 45 min free meeting and decide whether we meet online or offline. After understanding the need and a matched project plan, success is following.
typical product registration
Choose any topics for an evaluation
Our expert sits in your team
Predicable and cost-saving
We can also meet regulaly at flat rate basis
Till you are satisfied
Depending on clients demand we are playing with options to send our RA expert to lead an unexperienced group and leave a sound Chinese dossier to self-compilation. If the resource is lacking at company, we are flexible to focus on burning theme (type testing coordination, writing clinical evaluation, editing post market report).
With us you will save budget with our efficient way to work. We could charge only if the allocation is used in an hourly base or we meet at jour fixe to solve the problem at an annual flat rate. The unique payment of “Donate upon satisfaction” is a rising star. You decide it how much to pay after getting our expertise opinion or approved certificate.
Procedure with Chinese elements
Conrolling of Chinese related saves not just money and time
You deserve to chose the best offer and opinion
We spport with gap analysis and action
timeline of registration, prove of documents and competitor analysis
We try to improve Chinese partners by audit with your requirements
We explain auditor your process
Either IFU, Label or UDI, with us is garantee
You have your own process from design of device, verification and validation, registration to distribution of device. Oft it must be revised due to changed and additional different Chinese requirements. We are supporting with our best practice.
Controlling is rarely at regulatory affairs, however is important as a long term stabiliizer. Everybody is happy if the Chinese registration or Chinese inspection is behind. The trouble is turning up till next change registration, next revision of instruction for use or if another colleague takes the task over. The old folders and documents are badly to recognize and understand. We have a critical and useful view to provide some suggestions to optimize the registration dossier, communication with representative, distributor, authority and users.
Oft you have an offer, expertise opinion or deficiency letter with which you can’t start. Ask us for a neutral opinion.
The soft skills behind regulatory affairs are interdisciplinary and intercultural. With these weapons you can talk with every R&D head, CEO, local partner as representative, reviewer and inspector form authority. We know western and pan-Asian mentality, regulatory difference and whole life cycle of medical device. Use our expertise as bridge to pass overseas inspection, to submit post market reports, to monitor and improve the quality of Chinese partners.
Dear Sir/Madam,
Thank you for contacting us.
We will answer you as soon as possible.
regards,
CEO
Antonio Lee
Easychinapprov
China, Germany
Dear Sir/Madam,
Thank you for contacting us.
We will answer you as soon as possible.
regards,
CEO
Antonio Lee
Easychinapprov
China, Germany
Frankfurt, Stuttgart Germany
Sun Dong An Plaza, No. 138
Beijing China
info@easychinapprov.com
0049-17638379004
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E-Learning "MyComplinace"
Learning Chinese regulation and global regulatory affairs
Participation possible any time.
Discount during black week 19% ~ 50%
Article:
International market of medical device for Startups,SME
Overseas inspecion starts again
Testing beyond and for registration
Significant changes of medical device in China, EU, MDSAP countries
Meet us in next conference:
Arab health in Dubai, 2025 Jan
Global compliance and training
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