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24 Standards in July: Time to Update Your Design Control

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.

  • 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
  • Medical device genotoxicity test – Part 6: In vitro mammalian cell micronucleus test
  • Medical 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
  • Dental amalgam
  • 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
  • Meridian stimulator
  • 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 standards. Please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

NMPA (CFDA) planned to update 300 technical standards from 2018 to 2020. These technical 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 technical 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.