Why are we doing this?
We noticed that many European medical device and in vitro diagnostics device businesses have great interest in the China market, but are lack of the language and the regulatory know-how to start their first step entering into the market - registering the devices under China National Medical Products Administration’s policies.
Is this a familiar issue to you and your business as well? If so, you’ve come to the right place!
We, Hohot Consulting together with our partner J MedTec, want to solved this problem by providing the one-to-one consultation sessions (half hour) to relevant European medical/IVD device businesses and professionals.
In short:
-
Your product is unique, and it deserves special attention than just an information-based webinar;
-
Your business’ nature towards China is unique, and we shall address that while planning your product’s NMPA registration;
-
Our mission is to facilitate business success between Europe and China;
-
We have the right talents and resources in the right field to have your questions answered professionally.
What can you get?
Our expert, Dr. Xu Chao, has experience with 150+ successful China registration projects for medical devices and IVD devices. Residing in Berlin, Germany, and frequently traveling across China and Europe, she understands deeply the pain points European businesses are facing when registering their medical and in vitro diagnostics devices in China.
From each free consultation session, we aim at:
-
Getting your most burning questions answered about your product’s registration in China
-
Providing useful information and recommendations on NMPA registration practices
-
Suggesting next steps to help you get started with the process
However, please keep in mind:
Each consultation session with the expert is worth 200 €,
but we are offering it FREE OF CHARGE.
If you see the value having the free consultation, reserve your spot here!
Frequently Asked Questions
1. What can or can’t I ask?
It’s completely up to you. Still, here are some suggested areas for medical and IVD devices you can consider with:
-
Classification determinations in China
-
Class I device notification in China
-
Class II and III device registration in China
-
Green Channel Fast Registration process for innovative devices and prioritized devices in China
-
Legal representation for your medical devices in China
-
Registration renewal and change submission in China
-
Clinical trials in China and alternatives
-
Medical writing in Chinese
-
Medical device and IVD device affairs in Hong Kong
2. How does the reservation process go?
Step 1: Please fill out your reservation form here.
Step 2: Our staff will reach out to you, and agree on the consultation time
Step 3: Our staff will send a meeting confirmation email to you with agreed time and link to the online meeting
Step 4: Please mark this session on your calendar and make sure you will show up to the meeting
Please note: if there’re any chances that we have to re-arrange the consulting session due to personal reasons of the expert, we will let you know beforehand.
3. What do I need to prepare for the consultation meeting?
We would really appreciate it if you can provide as much information as possible of your business, product(s) and your target with the China market while filling out the reservation form, so we can educate ourselves well before the consultation meeting with you, and have the meeting more productive.
At Hohot Consulting, we handle personal and private information with care and according to GDPR practices. You can learn more about our privacy policy from here.
4. I still have questions before reserving my spot, how can I reach out to the staff?
You can contact Hohot's team:
-
E-mail: info@hohot.fi
Hohot Consulting Ltd.
Hohot Consulting is a consulting firm speicalized in business development for European businesses in China. Headquartered in Finland, we have a team of 10+ consultants helping your medical equipment business succeed in the China market. Our services include: product and service localization, IPR and legal support, market research and entry strategy, translation and interpretation, e-commerce and PR management, taxation & financial analysis, import and customs clearance, incorporation in China, and procurement management.
J MedTec Ltd.
With leading experts in medical devices strategic consulting and CRO services, J Medtec focuses on China market entry (regulatory, clinical, and quality), China market strategy, and China operation support for international clients. J Medtec's team consists of experts in medical device clinical, regulatory, quality, testing, investment, and sales/distribution. J Medtec has a strong network of partners with global business and operation experiences in both China and US/EU, and strength of ability to balance strategic thinking with swift execution.