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2024 China NMPA Bluebook is here:

Urgent Needs of Medical Products to Combat 2019 Novel Coronavirus

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China national NMPA informed local NMPAs on Monday Jan 27 to allow import none -NMPA approval devices but have FDA approval, CE mark, or Japan approval, to help conquer 2019 Novel Coronavirus (“2019-nCoV”).

We sincerely hope the overseas manufacturers for following supplies contact us ASAP. gpalma@ChinaMedDevice.com.

  1. Medical protective clothing with rubber strip (piece)(complying with GB19082-2003)
  2. Medical protective mask (N95, complying with GB19083-2010)
  3. Surgical mask (complying with YY0469-2011)
  4. Disposable Medical Cap
  5. Disposable Medical Shoe Cover
  6. Goggles
  7. Protective helmet
  8. Disposable isolation gown
  9. Nitrile gloves
  10. Sterile gloves
  11. Non-contact infrared thermometer

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 representative 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.

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