The NMPA granted Innovation Approvals to three gastroenterology and urology devices in June 2022:
- Beijing Huake chuangzhi: Ultrasound endoscopy system for gastrointestinal diagnostic
- Ningbo Shengjiekang: Disposable cryoablation balloon catheter
- Suzhou Kangduo Robotics: Laparoscopic surgery system
These three devices are intended for use in gastrointestinal endoscopy, bladder cancer and Laparoscopic surgery support with unique innovative advantages.
Key Takeaways for Overseas Manufacturers:
Even though these three devices are domestic medical devices by Chinese manufacturers, overseas manufacturers can apply for innovation pathway as well. Overseas and domestic manufacturers share equal opportunity in fast-track applications such as innovation approval. Manufacturers can initiate innovation approval applications while applying for China Patent & Trade Office coverage to shorten the review time. Patent just needs to be public announced.
Key benefits of innovation approval are its dedicated more senior reviewer and the priority review status during the registration review phase.
Below are requirements for innovation approval:
NMPA issued Innovation Approval Final Guidance on Nov 5, 2018. All medical devices and IVD products must meet all the following criteria to be qualified for the innovation approval pathway:
- Class II / Class III Medical Device with significant clinical application value
- Own valid invention patents
- Have China PTO coverage
- Complete the preliminary study on prototype with traceable data, and
- An authorized in-country legal entity. Does not need to be your own entity. You can authorize a local agent.
To better understand the innovation approval pathway requirements, take the approved Laparoscopic surgery system from Suzhou Kangduo Robotics as an example:
The system consists of a surgeon console, a patient operating table, surgical instruments, and accessories. The physician uses the master-slave manipulator system to control the minimally invasive surgery and so as to be used for upper tract urological laparoscopic surgery.
The surgeon console is the primary interface of the laparoscopic surgery system. The surgeon has two main hand controllers and foot pedals to control 3D endoscope and surgical instruments to perform surgical operations. The patient operating table, as the patient interface for surgical interventions, functions to support surgical instruments and the laparoscopic machine. As the hand controllers and foot pedal manipulate from the surgeon console, robotic arms operate accordingly. Each arm has multiple degrees of freedom allowing flexibility and precision, filtering hand tremors. And surgical instruments assist in surgical cutting, suturing, clipping, etc.
Laparoscopic surgery system owns self-intellectual property rights. It improves quality and ensures safety of operation as compared to the traditional ones; it has a lower cost of treatment as compared to the imported ones.
China NMPA granted approval for such Laparoscopic surgery system and aim to better protect patients using such devices.
I would love to hear about your experiences and challenges on China medical device innovation applications.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------