An analysis of medical device registration and market access in China /

Abstract

The focus of this research is in the area of medical device registration and market access in China. Such a study is important as China is one of the largest markets for medical devices in the world making it an important strategic target market for medical devices manufacturers. There were four research questions to be addressed - 1) What is the current economic environment for medical devices in China? What are the projections for the future state? 2) What has changed in the medical device regulations in China, with the updated regulations enforced in 2014? 3) What is the impact and challenges to product registration and market access in China? 4) What can the regulatory function do to ensure they create a successful regulatory strategy for Class II and Class III device approval in China that will aid market access?

This dissertation met these multiple research questions through an extensive study of relevant literature and the implementation of practical research. The practical research was carried out through a three-pronged Case Study approach which included a sample product case review from one multinational company, a qualitative questionnaire with one multinational company’s senior regulatory leaders and a qualitative/quantitative questionnaire with Regulatory and Quality professionals from numerous companies.

This research produced a number of key findings. The combination of the size of the Chinese market and the projected increased demand for medical devices has positioned China as a critical market for a medical device company to gain access. The survey confirmed the understanding of the importance in accessing the Chinese market. There are however challenges with the new regulations which were implemented as per CFDA’s Order 650 issued in 2014. As per the literature review and practical research one key challenge to registration is echoed repeatedly, this is the requirement for local Clinical Trials. If a clinical trial is required it will bring increased timelines, cost and resourcing to access the market in China. Understanding the Requirements, Submission & Deficiency Process, Country of Origin, Approval Timelines, Clinical Evaluation, China Specific Standards and Change Control were all also identified as key challenges to product registration. All these factors accumulate in long x lead times for product approval and ultimate market access. As per the literature review and survey conducted Copying, Lack of Local Knowledge, Product Registration, Reimbursement and Change Control were all identified as challenges to market access.

The research recommended several strategies for the Regulatory function to employ to overcome the challenges outlined and to facilitate a medical device businesses success in China. One key recommendation is ‘Communication’, a recurrent theme across the practical research. This may be communication with your Chinese colleagues or your local agent to understand requirements. It may also be communication within your own company outlining lead times and the complexity of the approval process or the regulatory advantages to the business of setting up manufacturing within China. This will help with internal strategic planning and ensure that the business is aware of the burden required to access the market in China. The regulatory function should constantly review new guidance’s from CFDA to ensure the optimum regulatory strategy is outlined for any device. New processes offered by CFDA need to be utilized to a company’s advantage. It is recommended that a regulatory function create its own internal procedures for China. It is a complex pathway that needs to be formalized rather than relying on an individual’s experience with China. It is also recommended that your company looks for opportunities for advocacy in China. There are numerous challenges and Industry should use the appropriate mechanisms to influence CFDA.