How to work with us?

Market access of Medtec to Chinese Market

1. Chose and use your first contact

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.



2.    Select the way to work together

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.



3.Define the details of the service

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.