EasyChinapprov           

Agile project of global registration of medical device
International registration

International registration, regulatory talent, academia in regulatory science, business development and Chinese plattform

International registration

Easychinapprov enables international

We have international clients and network with international Partners too. Based on similar technical documentations we approach in multi-country lane. It is way easier to fit country specific requirements with help of intelligent document compilation. We support you also medical device registration in:

 

Calculable with clear regulation

  • Japan

Communication is a barrier

  • Korea

Dealing with testing is the key

English documents are sufficient plus traditional Chinese of labelling

MDSAP certification can leverage review time

  • Australia/UK/Swiss

Unexpected fast if in EU is approved.

Anvisa is basic, Inmetro getting easier, Anatal complex

  • Mexico

Authority starts to accelerarte the review again.

 

As for product registration we could accompany


We still welcome any consulting partners (RA, QM, CRO, EU/UK/SWISS representative) to join the cooperation to approach more international registration together.


Contact us as well for your regulatory affairs project. You can chose one of the best country specific personals e.g. 20 hours per week.

We can work remotely and can come to your group in a regular basis.


Divergence view looks better.

Academia

Easychinapprov can be scientific

Publication


Regulatory science should be strenthed because the regulatory knowledge has its history, international context, market background and scientific argumentation. If you want to publish a book, a paper, compare Chinese regulation with your key markets and even write your thesis for academia, we are always here to contribute together.

 

We can always share your articles without “impact point” however regulatory impact.


Training


Training of employees or newcomers is not just needed to get a job or pass the inspection of ISO 13485. It is unique to gather inquisitive regulatory affairs personals to understand complex regulation especially in Chinese market of medical device and IVD either for people without regulatory affairs knowledge or for experts.

 

We want to train your regulatory affairs groups or to cooperate with medtech organizations for a workshop or even in a conference with our in depth training addressing new regulation trend in China and troubles in unnoticed regulatory practice.


No worry if you have no time. Visit our Elearning (Starting in Oct, 2023)


Pool of Chinese regulatory affairs manager


Easychinapprov introduces the perfect match

We train a lot of junior and senior regulatory affairs manager in term of Chinese and global regulation.

They are searching permamently the perfect company to enrich the group.


Are you searching a qualified RA expert in Chinese or global registration? Either in Europe or in China you cant find a trustful colleague. Even with network you can prove her or his regulatory knowleadge.


We can search as well your next Mr/Mrs. Right. The benefit is that we can understand your regulatory need to select the next personal and provide exceptionally the onboardings with soft skills.

Business development in China

Easychinapprov oversees succsess

Contact us if your success in China matters.


Either you are investors as venture capital or any other economic stakeholders. The professional and neutral legal regulatory partner leaves your planning controlled, risk-based and transparent.

 

Many manufacturers which have Chinese business don’t have controlling of their legal representative, distributor and other Chinese partners. You must think about cost or risk behind sound revenues in a long term. We are dedicating to a health investment with easy China controlling.

 

Many manufacturers want to start Chinese business and can’t decide it due to too different opinions. We are audience for your ideas and planning scenarios. After a feasibility evaluation of your business we act as a premium partner to provide best pathway to establish a legal entity, to outsource or build up reliable Chinese regulatory employees, and even to engage in Chinese production site.

Platform of your Chinese voice

Easychinapprov connects succsess

In direction to China


The Chinese market of medical device and IVD is changing rapidly. For not global player it is painful that interested party to invest doesn’t know your product with high technology and clinical use and your demand to step into Chinese market.

 

Don’t worry we can bring your inquiry in our platform. Be ready to get contacted by a potential partner.

 

Conversely from China


There are more and more trustworthy investors or original equipment manufacturer partners at medtech sectors from China who wish to understand your products, business plan and economic situation before investment. They have often some special inquires adapting to government’s specifications and valuable Chinese network.

 

Use our platform too to attract more manufacturers who will share your vision in China.

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