Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in July 2025. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
27 Class III IVD Reagents Exempted from Clinical Trial
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents” on June 24, 2025, which exempts 445 IVDs from clinical trials, including 27 Class III IVDs. The draft was published in November 2024. Implementing risk-based clinical evaluation, the catalog is intended to make clinical exemptions more consistent with internationally accepted standards.
The catalog includes the Class III IVDs such as Herpes Simplex Virus Type I (HSV I) IgG antibody kit, Rubella Virus IgG antibody kit, Adenovirus IgG antibody kit, Ketamine test kit, Complexed Prostate-Specific Antigen (cPSA) kit, Total Prostate-Specific Antigen (tPSA) kit, etc. For the full list click HERE
Three National Standards for Cardio Implants Take Effect in July
Thirty-six medical devices standards take effect in July 2025, including three national standards for cardiovascular implants. These newly established or revised standards are aimed to facilitate manufacturers with local type testing and regulatory submission and make them more consistent with the international counterparts. The 36 standards also impact the dental, Plastic Surgery, General Hospital, Orthopedic, etc. Click HERE for more information
NMPA Reviewers on Product Structure Design of Dental Implant
Dental implants are permanent implantable medical devices inserted into bone tissue to replace natural tooth roots. NMPA reviewers published an article that summarizes the current state of dental implant structural design and discusses key technical review considerations based on regulatory experience, aiming to provide references for product development, registration, and evaluation. For the full article please click HERE
Priority Approvals
NMPA Review Report Released for Medtronic’s EV-ICD
The NMPA granted innovation approvals to Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV-ICD) and issued a review report. This product is used in conjunction with compatible extravascular implantable cardioverter defibrillator (EV-ICD) leads to automatically deliver therapies—including anti-tachycardia pacing, cardioversion, and defibrillation—for patients who have experienced or are at significant risk of life-threatening ventricular tachycardia.
The review report summarizes the product overview, pre-clinical, and clinical studies results. Click HERE for the full report.