Assessing new developments in the pre-market regulatory process of medical devices in the People’s Republic of China

Abstract

The objective of this paper is to provide a systematic overview of the Chinese medical device registration processes, identify challenges and suggest how these can be addressed. In addition, the paper will outline the impact of new policies and regulations since the restructuring of the China FDA. A systematic review was performed for journal articles between the year of 2009 and 2013 in the following databases: PubMed, ScienceDirect and Zhongguozhiwang. The review has identified 184 papers which were potentially relevant. Seventeen articles were included in the review, which highlights the challenges and opportunities related to the medical device registration process. In order to understand the actual impact of the regulation environment and its policies including the lack of regulatory guidance regular assessment updates are crucial. The results of this paper are aimed at informing regulatory bodies, health policy decision makers, national and international Health Technology Assessment networks as well as medical devices manufacturers.

Keywords::

• China
• legal/regulatory issues
• medical device
• medical technology

Financial & competing interests disclosure

This research is supported by the German Federal Ministry of Education and Research (BMBF), project grant no. 13EX1013B, as part of the National Leading-Edge Cluster Medical Technologies ‘Medical Valley EMN’. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The Chinese medical device market has been growing at a rate higher than its gross domestic product, with an average 25% increase in 2011, which makes China an interesting emerging market for national and international medical device manufactures.

• Getting a medical device registration certificate in China is a complicated, time-consuming and at times even difficult process.

• Although major policy planning and changes are currently underway to address these problems, some major structural problems remain.

• The restructuring of the previous State Food and Drug Administration to the China Food and Drug Administration in 2013 was the largest restructuring since its establishment in 1998. The China Food and Drug Administration has made a concentrated effort for regulating drug and medical devices affairs since then.

• The old Regulation for the Supervision and Administration of Medical Devices was the first official document issued at a regulation level in 2004, and its recently issued new version will bring more developments into the regulatory process of medical devices in China.

• The new regulatory policies in place focus more strongly on the clinical effectiveness and safety of medical devices in China.

• The main challenge concerning the ‘products technical requirements’ and the ‘type test report’ in the regulatory process was related to its legal status and openness for interpretation, the new Regulation now includes improvements regarding specification of requirements.

• The new Regulation clarifies that if a medical device fulfills one of the three requirements, it should be exempted from clinical trials, which signifies a major simplification for manufactures.

Notes