Shanghai Wicresoft’s “Bioabsorbable Rapamycin Eluting Coronary Stent System” is the latest “Innovative Medical Device” to be approved by China’s National Medical Products Administration (NMPA).
Since 2014, a total of 282 innovative medical devices have been approved by the NMPA. Shanghai Wicresoft’s product is designed to address ischemic heart disease caused by primary coronary lesions by improving coronary lumen diameter.
Key Features of the Approved Product:
- Composition: The product comprises a drug-eluting stent and a delivery system. The stent consists of three components:
- Stent Matrix: Made of levulinic polylactic acid (PLLA).
- Development Marker: Located at both the proximal and distal ends of the stent.
- Drug Coating: Rapamycin, sprayed only on the outer surface of the stent using a single-side drug coating technology.
- Delivery System: Utilizes a rapid exchange balloon dilatation catheter for deployment.
- Sterilization: The product is sterilized via irradiation and is intended for single use.
Technological Advancements:
The innovative single-side drug coating technology enhances drug utilization and promotes vascular endothelialization by limiting the drug coating to the outer surface of the stent. This targeted approach potentially reduces the risk of drug-related complications and supports better healing of the vessel lining.
Regulatory Oversight:
The NMPA has emphasized the importance of robust post-market surveillance to ensure patient safety and the efficacy of the product in the clinical setting.
Examples of Overseas Innovative Medical Devices Registration Approved in China Since 2014
A total of 35 overseas innovative medical devices have been approved by the NMPA since 2014. The majority of these approved products are from the USA. 
Regulatory Pathways for Overseas Manufacturers
- Innovative Medical Device Pathway:
- The NMPA offers a dedicated “green pathway” for the registration of innovative medical devices. This pathway is designed to accelerate the approval process for devices that offer significant advancements over existing products.
- To qualify, a device must demonstrate novelty, have proprietary intellectual property rights, and show a clear clinical advantage over current therapies.
- This pathway is highly beneficial for overseas manufacturers as it can significantly shorten the time to market.
- Simplified Registration Procedures:
- It allows medical devices that do not already have home country approval such as the CE mark or FDA approval to apply to the NMPA for innovative medical device status.
- If approved, then the product will be assigned a dedicated reviewer by the NMPA and the registration process will be faster than the standard route by up to 4-6 months.
- Post-Market Surveillance and Compliance:
- Once a product is registered, the NMPA emphasizes the importance of ongoing post-market surveillance to ensure continued safety and efficacy. This involves regular reporting, adverse event monitoring, and compliance with Chinese standards.
- Overseas manufacturers must be prepared to invest in local infrastructure or partnerships to meet these regulatory requirements.
Further information
Read the original announcement on Innovative Medical Devices Registration Approved by China NMPA.
If you are interested in innovative medical devices registration, please contact Cisema for more information.
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