London, UK (PRWEB) November 14, 2014
China’s medical device market has huge growth potential. More and more overseas medical device manufacturers and producers are attracted to penetrate such a lucrative market. The country’s medical device market is forecast to reach about USD 57 billion by 2015, surpassing Japan to become the 2nd largest medical device market only after the USA.
Nevertheless, China’s regulatory framework for medical devices is going through radical changes. The country’s new authorities have begun strengthening the supervision and administration of the national medical devices sector. The Chinese approach to the administration of medical devices registration is quite unique. The processes of application and approval, clinical assessment and clinical studies, the requirements for application dossiers differ from those in the EU countries and USA. The preparation of application dossiers compliance with overall new regulations becomes as the key for overseas medical device entry into Chinese medical device market. The foreign and transnational medical device makers must have a deep understanding of the up-to-the-minute Chinese regulations on the registration of medical devices. Otherways, the restrictive legislative requirements and delays in approvals eat up one’s energy and time to make inroads into such a high-growth medical device marketplace.
New study “Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition)” developed by Access China Management Consulting Ltd. is now available MarketPublishers.com.
Title: Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition)
Published: November, 2014
Price: US$ 1,250.00
The research publication provides complete and accurate information on the overall novel requirements of application dossiers for medical devices registration or recordation in China, besides providing practical guidance for achieving a successful approval for overseas medical devices entry into the domestic market.
- Deep review of the dramatic changes in some of the Chinese regulations on medical devices.
- Look into the latest regulations for medical device registration and recordation in China.
- Unbiased insights into the country’s unique approach to medical device registration or recordation, laying the knowledge foundation for putting it in practice.
- Information on the number of application dossiers for imported overseas medical devices recordation and registration to be prepared, and also comprehensive requirements for application dossiers of imported overseas medical devices recordation and registration.
- Detailed listing of basic requirements for effectiveness and safety of medical device products.
- Practical guide to conducting the complicated and exclusive clinical evaluation for the registration of imported overseas medical devices in China.
- Practical guidelines on how to conduct the clinical trials for imported foreign medical devices registration in the country.
- All-round description of the approval process for imported overseas medical devices registration.
- Full text in English of China’s latest regulatory requirements for preparing application dossiers for imported overseas medical devices recordation and registration.
More new reports by the publisher can be found at Access China page.