The NMPA issued six draft clinical guidelines, for predicate-comparison, on October 25, 2022, soliciting public opinions. Your feedback needs to be submitted by November 21, 2022.
View our service page on predicate-comparison and clinical evaluation report (CER).
Relevant NMPA Clinical Guidelines
- Clinical evaluation guideline of hip prosthesis for same-variety comparison
- Clinical evaluation of interbody cage for same-variety comparison
- Clinical evaluation of positron emission/X-ray computed tomography system for same-variety comparison
- Clinical evaluation of medical X-ray diagnostic equipment (Class 3) for same-variety comparison
- Clinical evaluation of laser therapy equipment for same-variety comparison
- Clinical evaluation of soft contact lens for same-variety comparison
For an English copy of any guideline above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
If you have similar devices entering China, please leave your comments with us. We will consolidate your opinions and send to the NMPA.
About China Med Device, LLC
China Med Device, LLC (chinameddevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.