NMPA announced establishments or revisions of 24 Medical Device Industry Standards on July 30. If these standards are applicable to your device, please check your product’s design file and your Product Technical Standards (PTR) in your new or existing medical devices.
Indutry Standards Being Impacted
Surgical sheets, surgical and cleansing suits for patients, medical staff and equipment – Part 8: Product-specific requirements
In vitro diagnostic medical device Information provided by the manufacturer for in vitro diagnostic reagents for biological staining
Ultrasound bone densitometer
Medical device genotoxicity test – Part 3: TK gene mutation test using mouse lymphoma cells
Device genotoxicity test – Part 6: In vitro mammalian cell micronucleus test
Device complement activation test – Part 3: Determination of complement activation products (C3a and SC5b-9)
Small aperture connectors for medical fluids and gases – Part 20: General test methods
Human chorionic gonadotropin assay kit
Evaluation of immunogenicity of medical devices – Part 6: Determination of spleen lymphocyte subsets in animals by flow cytometry
Guide to research on the compatibility of disposable infusion devices with drugs – Part 2: Research on leachables
Disposable medical protective shoe cover
Disposable medical protective cap
Chromosome aneuploidy detection kit for pre-embryo implantation
General technical requirements for intravascular ultrasound diagnostic equipment
Radial load test method for balloon dilatation and self-expanding vascular stent
Acupoint impedance testing equipment
Parathyroid hormone assay kit
Vibrating and slamming drainage machine
Basic electroacoustic characteristics and measurement methods of array pulse echo ultrasonic transducer
ABO detection card (column agglutination method)
Evaluation of neurotoxicity of medical devices – Part 1: Guide to selection of trials for evaluation of potential neurotoxicity
UDI system basic terminology
ChinaMed Device provides copies of the above industry standards. Please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
Implications of Updated Industry Standards
NMPA (CFDA) planned to update 300 industry standards from 2018 to 2020. These industry standards impact your products whether renewal or new registration. All products have to be brought to the latest NMPA (CFDA) technical standards! ChinaMed Device has a team of technical engineers who can assist you to understand the industry standards and their impacts on your products:
Assessing relevancy of the new standards to your products
Gap analysis between your product and current NMPA (CFDA) standards
Mock testing for your product compliance
Writing and updating your Product Technical Requirement (PTR).
Local type testing on-site support at NMPA (CFDA) testing centers
Software compliance to NMPA (CFDA) framework, cybersecurity and wireless access
Assisting in design input
Customized NMPA (CFDA) regulations and standards update
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About ChinaMed Device, LLC
ChinaMed 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 (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.