NMPA granted innovative status to nine medical device manufacturers in May, including three foreign manufacturers and six domestic ones.
- Rapid Medical: Thrombectomy stent (Imported device)
- Keystone Heart: Anti-embolization distal brain protection device (Imported device)
- AccuMedical: Blood flow guiding device for intracranial aneurysm
Gastroenterology and Urology
- ReCor Medical: Renal sympathetic ultrasound ablation system (Imported device)
- MicroPort Orthopedic: Surgery navigation and positioning system
- Kossel Medtech (Suzhou): Vena cava filter
- Xi’an Pule Bio: Crosslinked polyolefin aspheric intraocular lens
- Huizhou Haizhuo Keshai: Debridement waterjet
- Suzhou Leitai: Linear Accelerator
We have helped a leading radiotherapy equipment manufacturer to obtain innovation approval for their Ct-Linac, a combination of CT and linear accelerator. We completed its clinical trial in fewer than 12 months from patient recruitments to final data reporting. Please click HERE for more information.
NMPA utilizes fast-track approval pathway for medical devices with innovative status. The granted priority manifests in the classification determination, pre-clinical testing, QMS auditing, and NMPA reviewing/approving processes. Meanwhile, designated senior NMPA reviewers would check in and provide guidance throughout the whole expedited process.
The devices above have not been approved by NMPA but put into accelerated review process. They still need to go through normal registration process.
The NMPA Innovation Approval Guideline was published in November 2018. It states that medical device and IVD product must meet all the following criteria to qualify for the special review and approval procedure:
- 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.