The month of December has arrived which means the year is almost over. Stephanie Huang looks back on the biggest trends in the Chinese market of the past year.
What have been the biggest trends the past year in the Chinese market?
Strengthen the Post Market Surveillance
NMPA (CFDA) has started to strengthen the Post Market Surveillance and imposed severe penalties for violations. Decree No.1 for Medical Device Adverse Event Reporting and Re-evaluation was implemented on January 1st, 2019. NMPA adverse event reporting system goes live at the same time, which encourage end-users to report more proactively. Provincial NMPA offices will take major responsibility for surveillance of AE processing measures. China also joins IMDRF National Competent Authorities Report (NCAR) information exchange scheme in this September to better monitor the adverse events and recalls globally.
Extension of the MAH pilot program
Market Authorization Holder (MAH) pilot program has been extended from three trial cities to 21 cities/provinces. This program favourably helps industry manufacturers and research institutes without enough production capability to be certificate holder, while outsource/entrust manufacturing to one or multiple subcontractors across provinces. MAH reform lift registrant’s burden to invest and build their own GMP certified manufacturing site before certification and allow scientific institutes to focus on R&D and innovation. MAH applies to both Class II and III devices, but class III subcontractors need to be YY/T0287 or ISO13485 conformity. NMPA Pilot Work Plan for Expanding the Opening Up of MAH clarifies responsibilities for both MAH and Contract Manufacturer, and details how to implement such policy on its approved regions.
e-RPS into effect
Electronic Regulated Product Submission system (e-RPS) came into effect on June 24th, 2019. The system affects domestic Class III, imported Class II and III medical devices and IVDs. The scope includes initial registration, supplement, renewal, modification, high-risk Class III devices’ clinical trial request, modification of Instruction for Use (IFU), Innovation Approval application, etc. The folder structure of Regulated Product Submission Table of Contents (RPS ToC) replaces the old checklist as new guidance for technical dossiers preparation. All related notices and communications are processed, recorded, distributed and tracked electronically. E-submission greatly streamlines the submission process, improve the efficiency and replaced the paperwork submission.
Unique Device Identification rules into effect in China
Unique Device Identification (UDI) rules went into effect on October 1st, 2019 in China. The first trial group covers 64 implantable devices. UDI needs to be properly entered into the applicable devices ERPS registration system and be labelled on various levels of packings. Relevant standards and specifications are drafted, and a dedicated UDI database is developed. UDI rules also define the responsibilities and tasks of medical device manufacturers, code issuing entities, registrants, and authorities. Certified code-issuing agencies are required to submit an Annual UDI Report for the previous year to NMPA by January 31st each year. The registrants shall upload, maintain and renew the product identification and related data on the UDI database. Registrants are held accountable for the authenticity, preciseness and completeness of UDI data.