Policies
Lifecycle Checkpoints of Cosmetic Devices Released
NMPA issued the “Checkpoints of Common Violations of Regulations in the Production, Supply and Usage of Medical Cosmetic Devices” on November 25, 2022. It asks local NMPA offices to strengthen the supervision and inspection of cosmetic devices based on this document.
The violations and regulation-based solutions are listed for manufacturers to refer to. For our comprehensive review please click HERE
NMPA Reviewers on AI Process Optimization Software
NMPA published an article on artificial intelligence software for process optimization, illustrating on what the clinical applications of the software and how to do software validation.
Click HERE for more information, with examples of ultrasonic spectrum automatic identification, intelligent screening, neural automatic recognition and automatic recognition of heart structure.
Guidelines & Standards
List of Medical Device Mandatory Standards Released
The NMPA issued the “list of mandatory standards applicable to medicals” on November 11, 2022, directing manufacturers for type testing and regulatory submission. Over 400 mandatory national and industry standards are included.
The list is categorized by devices referring to the NMPA Medical Device Classification Catalog. Oftentimes, multiple mandatory national and industry standards may apply to each device.
For the full device standards, please click HERE
NMPA 3D Bioprinting Guidelines Ask Your Input
NMPA issued a notice “Information Solicitation on New Materials and Product Performance Evaluation for Biological 3D Printing”. It says domestic and foreign enterprises, scientific research institutes, clinical institutions, etc. are invited to participate in regulations of five bio-printed tissue repair devices: bio-ceramics, PEEK composite materials, bioactive bone repair materials, dental resorbable repair membrane materials, and aesthetic materials.
It lists ten documents to input your opinion. For the full list click HERE
Fast-Track Approvals
Boston Scientific’s First-of-its-Kind Sentinel Cerebral Protection System Gains Approval
NMPA granted innovation approval to Boston Scientific for the Sentinel Cerebral Protection System on November 2, 2022. The device belongs to “first-of-its-kind in China” scenario.
It also released the review report for Sentinel Cerebral Protection System, outlining the review items from the perspectives of product overview, preclinical research, clinical evaluation, and benefit-risk analysis. For more information please click HERE
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.
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- Source: https://chinameddevice.com/nmpa-roundup-november-2022/
