Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Comparison of Medical Devices Regulations in the EU and the People's Republic of China-Current situation and possible implications of the new Chinese Medical Device Guideline (2014)
Jing Yuan (Abschlußjahr: 2014)
Summary
Language: English
Based on the comparison of medical devices in the EU and in China in several important aspects, it has shown the characteristics and differences, and the advantages and disadvantages. Through the analysis of these aspects, the EU and China can learn from each other, do complementary advantages, improve own laws and regulations, as well as to better explore the international market.
- Different bases and backgrounds
In the late 1980s and early 1990s, the EU published medical device regulations. The Chinese "Supervision and Regulation of Medical Devices" was issued in 2000. In recent years, Chinese Medical Devices regulatory level has been greatly improved, but compared with the EU, there are still gaps. The published documents of annual conference "Global Medical Device Coordination Organization (GHTF)" has promoted the convergence of global medical device management. China learned from the EU and other developed countries and issued the new revised Chinese medical device regulations in March 2014. This effort of Chinese medical devices Authority provided favorable conditions and development space for the domestic and foreign medical device enterprises. - Different regulatory authorities and methods
In the EU there is no centralized EU authority that grants approval of medical devices. Instead private third parties (NBs), are hired by each manufacturer to determine whether its device meets safety and performance requirements, and to bestow a “CE Mark” on the device. A CE Mark, once granted, allows marketing in all EU countries. This management has its disadvantages. Although NBs have uniform certification standards and procedures, but they are private, for-profit organizations chosen and hired by the manufacturer. Medical devices approval by any NB authorized marketing throughout EU. Due to competition among NBs’ customers and other factors, the inevitable differences between the NBs on certification could not avoid. NBs are expected to partly reinvent themselves in the further. Not only will they need to employ much more expertise directly as opposed to contracting it in, they will also play a role in enforcement by means of conducting unannounced inspections of manufacturing processes and taking on a supporting role in vigilance follow up. In China CFDA is the central regulatory authority. CFDA leads to hierarchical management. Depending on the type of medical devices products, the registration and the supervision will be regulated, from high to low, respectively, by CFDA, provinces, autonomous regions and municipalities (food) drug supervision and authority. However, in practical work, the positive feedback and interoperability between the different supervision and authorities at all levels need to be strengthened. - Medical devices classification
Currently, both the EU and China classify the medical devices according to the product risk. The EU classifies the products in accordance with the intended. This classification method has a high degree of coverage and is easy to implement. The classification method in China is similar with the EU. However, due to the determination principle is multifactorial, such as based on the Chinese medical devices catalog. Such classification is not conducive to new product registration. Such classification is not conducive to new product registration, and sometimes the same kind of products is classified in different classification levels. Product classification is the basis to determine on medical devices management degree. It is expected to determine the classification, without the use of multifactorial classification rules, the main decisions should base on the intended use of the products. The procedure of the classification needs to be defined. - Quality Management Systems
The quality system standards EN 46000 series and ISO 9000 and ISO 13485 are established by EU. According these standards the NB reviews the production systems of the manufacturer. But the review of NBs not made public. Post-marketing data shared among Competent Authorities but not with the public. This is expected to be more transparency in the future.
Quality control has been the biggest factor restricting Chinese Medical Devices successful integration into the international market. In July of this year, CFDA issued "Medical Device Good Manufacturing Practice" (draft). This regulation increased supervision of medical devices, encouraged the advanced and eliminated the underdeveloped medical devices enterprises. It has become the industry trend to gradually improve the access threshold. - Clinical Tries
The new requirements in EU for clinical trials of medical devices are in the process of being revised. It expected to better protect patients involved in clinical investigations, to strengthen the role of the centralized database, Eudamed, for the collection of data related to the clinical investigations and introducing a new centralized system for notifications and reporting of severe adverse events as well as the possibility to centralize the application of the conduct of clinical studies in more than one EU Member State and to extend the scope of post-market clinical follow-up by manufacturers.
In the Chinese new regulation, one of the key concerns is on clinical trials. The concerns relate to clinical trials needs for Class II and Class III products. It is proposed that all Class II and III devices need clinical trials unless they meet certain criteria or are included on an exemption lists. The CFDA has released for comment its exemption catalogue, but dynamic updates are more expected for the industries. Possibly a “decision tree” that allows exempt products to be appended on an ongoing basis. A clear guidance on it would be needed. - Incident monitoring and management
The EU already has established relatively complete feedback and reporting systems. Incident monitoring and management was an important part in the Chinese new regulations for medical devices. The definitions and procedures of recall system, voluntary recall, request recall and force recall need urgent to be established. Tracking reports for some high-risk products is expected, in order to try to avoid incidents and better protect the user's safety and health.
However, despite numerous challenges in China, e.g. intellectual property rights (IPR), China’s regulatory barriers, complex price tendering process, inconsistent reimbursement policies, and high tariffs, for the EU medical device enterprises, China's should be seen more as an opportunity than a challenge due to its growth potential. Medical device companies should always pay attention to changes in China's related policies, timely develop the appropriate strategies, and grasp the trends of policy and market. The China's new medical devices regulations provided a lot of supports for the medical devices enterprises. China’s burgeoning medical device market is translating into significant opportunities for EU medical device enterprises.