CFDA: 12 IVD Standards to be Updated in 2019 – Huge Impact on Renewals and New Registrations

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CFDA: 12 IVD Standards to be Updated in 2019 – Huge Impact on Renewals and New Registrations

NMPA (CFDA) announced “2019 Medical Device Industry Standard Revision Draft Plan” for public comments on December 11, 2018 to medical device/ IVD regulations in order to be more consistent with the international standards. There are 12 IVD industry standards going to be established or revised, among the 94 technical standards expected to be updated in total in 2019.

Whether you are renewing or submitting new registration, your IVDs 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 up to date with the new standards. ChinaMed Device, LLC has test engineers at CFDA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.

Complete list of IVD section of the Standard Revision Plan:

  1. Immunohistochemical reagent
  2. IVD testing systems – Performance evaluation methods – Part 1: Precision
  3. IVD testing systems – Performance evaluation methods – Part 2
  4. Sperm quality analyzer
  5. Blood gas analyzers
  6. Blood analyzer calibrator
  7. Mass spectrometer – Part 2: Matrix-assisted laser desorption/ionization (MALDI) time-of-flight mass spectrometry
  8. Fluorescence immunochromatography analyzer
  9. Gram-negative bacterial lipopolysaccharide (bacterial endotoxin) assay kit
  10. Hepatitis B virus e antibody detection kit (chemiluminescence immunoassay)
  11. Amino acid and carnitine detection kit (tandem mass spectrometry)
  12. Hereditary hearing loss gene detection kit

About 300 technical standards of medical devices/IVDs are expected be updated between 2018 and 2020. The updated standards will specify the modifications, effective dates, and give recommendations for registration applications.


For NMPA (CFDA) link of the draft Plan, please email We charge nominal fees for the translation.

We also can help you find the applicable required technical standards, write PTR, perform local type testing at the CFDA testing centers for your medical devices and IVDs.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC (, a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter 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. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.