NMPA published seven pathology and clinical chemistry guidelines in August, to direct manufacturers for clinical trial, local type testing and regulatory approval:
- Clinical trial guideline on anti-tumor companion diagnostics (CDx) already on the market
- Registration guideline on Cryptococcal antigen reagents
- Registration guideline on rotavirus antigen testing reagents
- Registration guideline on Group B streptococcus nucleic acid testing reagents
- Registration guideline on genetic deafness-related gene mutation detection reagents
- Registration guideline on Mycoplasma pneumoniae IgM/IgG antibody detection reagents (draft)
- Registration guideline on human parvovirus B19IgM/IgG antibody detection reagents (draft)
For an English version of any guideline above, please email us at info@ChinaMedDevice.com. We can also help you deliver opinions to the NMPA for the draft guidelines.
What are the Implications
Whether you are renewing or submitting new registration, your medical devices and IVDs need to meet these new guidelines. 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 guidelines. 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 regulation.
China Med 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. info@ChinaMedDevice.com.