These aspects will be strictly regulated; new regulations for the medical device industry are on the way.

Recently, one of the sub-forums of the 4th China Pharmaceutical Regulatory Science Conference (2019) - the Medical Device Regulatory Forum - was held at the Beijing Conference Center, attracting nearly 200 representatives from regulatory agencies, pharmaceutical companies, and associations.

The director of the Medical Device Supervision Department of the National Medical Products Administration, **xiong**, stated at the meeting that the revision of the "Regulations on the Supervision and Administration of Medical Devices" has entered the review stage. This revision mainly involves comprehensively strengthening the medical device registrant system, optimizing and improving the requirements for registration inspection, clinical evaluation, and clinical trials, gradually implementing the **identification** system for medical devices, regulating online sales, establishing a professionalized inspector system, increasing regulatory measures, and increasing penalties.

Currently, the key tasks of post-market surveillance of medical devices by the National Medical Products Administration include continuously improving the regulatory system for medical devices, effectively strengthening risk management of medical devices, strengthening supervision and inspection of medical device production, strengthening supervision of the operation and use of medical devices, strengthening monitoring of adverse events of medical devices, conducting supervision and spot checks of medical devices, strengthening the capacity building for medical device supervision, and deepening international exchanges and cooperation.

Regarding the continuous improvement of the regulatory system, work is underway to cooperate in the revision of the "Regulations on the Supervision and Administration of Medical Devices".

In 2018, the Ministry of Justice publicly solicited opinions on the "Draft Amendment to the Regulations on the Supervision and Administration of Medical Devices". Since 2019, the National Medical Products Administration has actively carried out the revision of the "Regulations on the Supervision and Administration of Medical Devices". Simultaneously, relevant regulations and systems for post-market supervision of medical devices are being studied and improved. For example, the production and operation quality management specifications for medical devices are being revised and improved, and an independent appendix software for medical device production quality management specifications is being released; promoting "streamlining administration and delegating powers," researching and supporting policies related to cross-provincial establishment of production sites and relocation of medical device manufacturers, etc.

In terms of effectively strengthening risk management, focusing on products and enterprises, every quarter, risk assessment meetings involving multiple departments are organized around various dimensions such as inspection, spot checks, monitoring, recalls, cases, reports, and public opinion, and the post-market surveillance risk consultation system and major risk and hidden danger reporting system for post-market surveillance are being improved; compiling the annual report on the quality situation analysis for 2018; strengthening risk analysis and judgment of innovative products; strengthening recall work management, timely releasing recall information and promoting the implementation of responsibilities.

In terms of strengthening production supervision and inspection, supervision and inspection have been strengthened. This year, special inspections of aseptic and implantable medical devices were organized; overseas inspections continue, expanding the scale of on-site verification of overseas companies' production, gradually expanding product coverage, and strengthening the analysis and handling of inspection results.

In terms of strengthening the supervision of operation and use, guidance and supervision are being implemented; investigations and studies are being conducted to understand the local work situation; "meetings instead of training" are implemented, providing training and guidance to the backbone personnel of the medical device supervision posts. At the same time, city and county-level market supervision departments are guided to conduct inspections of the operation and use links, strengthen the supervision of online transactions, and supervise and guide the investigation and handling of cases.

In terms of strengthening adverse event monitoring, the "Measures for Monitoring and Re-evaluation of Medical Device Adverse Events" is being implemented, supporting systems and guidelines are being formulated, publicity and training are being promoted, and the monitoring information network and database are being improved; key monitoring and monitoring risk assessment and disposal work is being carried out.

In terms of conducting supervision and spot checks, the supervision and spot check system is continuously being improved, and the "Regulations on the Management of Quality Supervision and Spot Checks of Medical Devices" is being revised, aiming to be released by the end of the year; supervision and spot check work is being organized well, and while conducting national spot checks, provincial drug regulatory agencies are guided to organize provincial spot checks, and the analysis, application, and disposal of spot check quality results are being carried out.

In terms of strengthening regulatory capacity building, the regulatory team is being continuously strengthened. Not only are part-time inspectors being selected and trained, with training classes for inspectors and on-site production inspection training being held to enhance practical abilities, but also innovative training methods are being used, conducting inspector training through online education platforms, and providing training on the knowledge of production, operation, and use supervision to regulatory personnel of provincial drug regulatory agencies and city and county-level market supervision departments. In addition, regulatory informatization is also being strengthened.

In terms of strengthening international exchanges and cooperation, international exchanges and cooperation continue, learning from advanced international management experience to improve the internationalization level of supervision; implementing the achievements of the International Medical Device Regulators Forum (IMDRF), strengthening international regulations research, and converting and applying them in combination with China's actual conditions; promoting the improvement of China's information exchange mechanism for the National Competent Authority Report (NCAR) of the IMDRF, promoting international exchange of risk warning information.