Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Drugs and Devices can be Taken out of Hainan’s Hospitals for up to Twelve Weeks
Hainan government issued the “Administrative Measures of Clinically Urgent Imported Drugs and Medical Device Taken Out of the Hospital in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone” on October 12, 2023. It says that the oral, topical, and subcutaneous injections of drugs and devices can be taken out when patients leave the hospital.
The amount of medicine taken out of the hospital should refer to the prescription regulations of medical institution. Based on the patient’s diagnosis and treatment needs, the time of leaving should in principle not exceed 4 weeks; for chronic disease patients with stable conditions and mild adverse drug reactions, the time can be extended, but should be limited to 12 weeks.
For requirements on longer-term subscription, traceability management platform and smallest independent packages, please click HERE
Guidelines & Standards
Guideline on Human Factors Design Asks Second Round Feedback
NMPA issued the notice “Soliciting Feedback of Guideline on Medical Device Human Factors Design for the Second Time” on October 11, 2023, after the first round released in May 2020.
The draft document introduces the Main Concepts (Human Factors Design and Usability; Users, usage scenarios and user interfaces; medical device usage and user operation), Basic Principles (human factors design positioning; use risk orientation; full life cycle management), and the design process. It also specifies the research materials for human factors design.
In the Design Validation and Confirmation section, it discusses the two phases: formative evaluation (human factors design validation) and summative evaluation (human factors design confirmation), and the importance of documenting and reporting:
For our comprehensive review including and considerations of imported devices, please click HERE
Fifty-four Draft Guidelines Issued in One Day
NMPA published 54 draft guidelines on October 25, 2023, for feedback. Feedback needs to be submitted by November 23, 2023. The guidelines include those for laser positioning system, nebulizer mask, bronchial blocker, catheter fixation device, micromanipulation tubes for assisted reproduction, etc.
Along with each document, the email and phone number of contact person have been given. Click HERE for the complete list of draft guidelines
Siemens’s X-ray CT Gains NMPA Innovation Approval
NMPA granted innovation approval to Siemens’s X-ray computed tomography equipment on October 17, 2023. This product uses innovative photon counting detector technology to count the number of incident X-ray photons and measure the energy level of the photons. Compared with CT using traditional energy integrating detectors, this product has higher spatial resolution and can directly acquire energy spectrum images. Click HERE for more information
Importation Halted Due to Address Discrepancies
The NMPA issued an inspection result on October 25, 2023, for the inconsistence of manufacturing addresses. The NMPA has decided to suspend the import, distribution, and use of the system. Click HERE for the detailed information on the incompliance