NMPA issued fourteen guidelines in July. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia, and immunology, etc.
Full List of Guidelines
- Technical review guideline on modification in vitro diagnostic reagents (draft)
- Nomenclature for medical imaging equipment
- Registration guideline on vision screener (draft)
- Guideline on Instructions for Use for rigid permeable contact lens for corneal shaping
- Registration guideline on equivalent model of customized personalized bone implant
- Registration guideline on finite element analysis data of orthopedic metal implants
Gastroenterology and Urology
- Registration guideline on clinical trial of hernia repair patch
- Registration guideline on electronic upper gastrointestinal endoscopy (draft)
- Registration guideline on nitrous oxide sedative and analgesic devices
- Renewal for instructions for use and technical review of tumor companion diagnostics based on similar therapeutic drugs (draft)
- Registration guideline on citric acid disinfectant (draft)
Obstetrical and Gynecological
- Registration guideline on disposable breast positioning wire
- Registration guideline on Dura mater (spine) membrane patch
- Animal study guideline on bioabsorbable coronary artery drug eluting stent
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.