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Research and Markets: China Medical Device & IVD Regulatory Handbook 2015Research and Markets (http://www.researchandmarkets.com/research/2wkw5t/china_medical) has announced the addition of the "China Medical Device & IVD Regulatory Handbook" report to their offering. The Chinese medical device market is one of the fastest growing in the world, recently overtaking Japan to become the second largest medical device market in the world. China remains heavily reliant on imported medical devices & IVDs to meet the needs of its growing and ageing population. Foreign manufacturers from over 100 countries export their medical devices & IVDs to China annually, in particular those from the USA, Japan, Germany, Switzerland, France, UK and Ireland. What does the China Medical Device Regulatory Handbook cover? - Obligations of Representative Agents of foreign manufacturers.
- Documentation required for the filing of Class I medical devices & IVDs. - Documentation required for the registration of Class II and III devices & IVDs and the Essential Requirements list. - Preparation of product technical requirements (referred to as product standards under previous legislation). - Registration management: Requirements for extending registration certificates upon expiry, procedures to report changes in information to the authorities. - Enforcement: The penalties and fine levied by the Chinese authorities. - Legislative requirements for adverse effect management, product recall and advertising, - Clinical evaluation requirements for medical devices & IVDs: requirements for clinical trials, deciding whether a product can be considered as an equivalent product, deciding whether clinical trial testing is required in China etc. - New Classification Rules: the new classification rules which come into effect on 1 January 2016 which will guide the classification of devices and the drafting of the Medical Device Classification Catalogue. Companies Mentioned - China Food and Drug Administration (CFDA) - China State Council - ClinicalTrials - Cochrane Library - Embase - MEDION For more information visit http://www.researchandmarkets.com/research/2wkw5t/china_medical
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