Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in April 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
247 Guidelines Impacted by 2023 Revisions Plan
The NMPA published the “2023 Medical Device Guidelines Revisions Plan” on April 4, 2023, in which 247 guidelines are affected. The plan involves the guidelines for technical review for type testing, clinical trial and registration, and Indication for Use (IFU) writing. It impacts 63 new Class III, 66 new Class II and 118 revised Class II devices guidelines.
Class III guidelines include those for hemodialysis equipment, single-photon emission/X-ray computed tomography system, positron emission/magnetic resonance imaging system, laparoendoscopic surgical system, high-frequency surgical instruments for flexible endoscopes, abdominal endoscopic surgical system, peripheral vascular stents, thrombectomy stents, etc. View the complete list of guidelines.
Error Correction Matters Added into Electronic Filing System
The NMPA issued a notice on April 19, adding error correction matters into their electronic Regulated Product Submission (eRPS) system, effective on April 20, 2023.
It also attached “folder structure of the electronic catalogue of declaration materials” as annex. Read more information.
Software Company Defects Found in Unannounced Inspection
The NMPA conducted a “fly inspection”, also known as an unannounced inspection, on Chenfang Sichuang Technology Co., Ltd. According to the notice published on April 17, 2023, the inspection found that the QMS issues from the perspectives of institution and personnel, design & development, and production management. See our comprehensive review.
Guidelines & Standards
Final Guideline on RF Aesthetic Devices Issued
The NMPA released the final version of “Registration Guideline for Radiofrequency Aesthetic Devices” on April 12, 2023.
The 29-page RF equipment guideline elaborates the review focus areas: registration unit division, performance index requirements, electrical safety requirements, software research, biological research, etc. Read our comprehensive review.
Two Imported Devices Gain Innovation Approval in April
The NMPA granted innovation approvals to seven devices in April 2023, for indications ranging from cardiovascular, orthopedic, neurology and ophthalmic. Among them are two imported devices from Alcon and Ubiosis. Read more information.