NMPA granted Innovation Approvals to two products from overseas manufacturers in August 2022:
- Ethicon: Absorbable Regenerated Oxidized Cellulose (AROC) hemostatic granules
- BioFire Diagnostics: Meningitis/Encephalitis (ME) multi-pathogen nucleic acid detection kit
Ethicon's product intended for use is in surgical and endoscopy surgeries. BioFire's product is intended for in vitro qualitative nucleic acids detection of 14 bacterial, viral, and stealth cocci in cerebrospinal fluid (CSF) samples from patients with meningitis and/or encephalitis. Both products have unique innovative advantages.
Key Takeaways for Overseas Manufacturers:
Overseas manufacturers share equal opportunity with domestic manufacturers in fast-track applications such as innovation approval. It may greatly accelerate the China NMPA registration process due to its special priority pathway as well as post market reimbursement benefits. Manufacturers can initiate innovation approval applications while applying for China Patent & Trade Office coverage to shorten the innovation approval review time.
Once innovation registration pathway is granted, the device will be allocated to the priority status, it will be reviewed by the dedicated senior reviewers to expedite the review process. In addition, you will benefit from the direct consultation with NMPA designated reviewer.
Below are more details to understand the innovative advantages of Ethicon's product:
Absorbable Regenerated Oxidized Cellulose (AROC) hemostatic granules
The product consists of model 3013SP absorbable regenerative oxidized cellulose hemostatic granules, which contains the device pre-assembled with 3g of hemostatic granules made of fine fiber compacted by a patented process for open surgery; and model 3123SPEA regenerative oxidized cellulose absorbable hemostatic granules catheter device, which can be used with 3013SP for endoscopic surgery.
The product is suitable for surgical or endoscopic surgery and is used as an aid in the control of bleeding from capillaries, venules, and arterioles when ligation or other traditional control methods are not applicable or ineffective. This is the first granular regenerated oxidized cellulose hemostasis product, whose particles are made from patented process of compaction of fine fibers, and its matching powder application device can make the instrument face without affecting the effectiveness and uniform spray of particles, which is convenient for surgical or endoscopic surgery.
More products used in surgical or endoscopic surgeries are granted for innovation approval by China NMPA providing better care to patients.
I would love to hear about your experiences and challenges on China medical device innovation applications, please email me for a further discussion.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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