NMPA (CFDA) issued the final version of “2019 Medical Device Industry Standards Revision Plan” yesterday (March 20), in which 93 medical devices, IVDs are affected. The Standards Revisions are aimed to facilitate manufacturers with local type testing and make standards more consistent with the international standards.
The Plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards and quality systems of the 93 medical devices and IVDs.
Revision of more than 300 industry standards for medical devices, IVDs and quality systems could be expected by the end of 2020, as NMPA announced in February 2018. 2018 Standards Revisions impacted 99 medical devices and IVDs.
Whether you are renewing or submitting new registration, your medical devices need to meet these new standards. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new standards. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new standards. ChinaMed Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.
Among the 93 revisions, unprecedented number of IVD standards are being established or revised:
- Immunohistochemical reagent
- IVD testing systems – Performance evaluation methods – Part 1: Precision
- IVD testing systems – Performance evaluation methods – Part 2
- Sperm quality analyzer
- Blood gas analyzers
- Blood analyzer calibrator
- Mass spectrometer – Part 2: Matrix-assisted laser desorption/ionization (MALDI) time-of-flight mass spectrometry
- Fluorescence immunochromatography analyzer
- Gram-negative bacterial lipopolysaccharide (bacterial endotoxin) assay kit
- Hepatitis B virus e antibody detection kit (chemiluminescence immunoassay)
- Amino acid and carnitine detection kit (tandem mass spectrometry)
- Hereditary hearing loss gene detection kit
For English version of the Standards Revision Plan, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For slides of AdvaMed sponsored webinar on Type Testing in China, please email us.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.