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Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China
Synopsis
Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China not only provided a comprehensive and thorough knowledge of the overall new requirements of application dossiers for medical device registration or recordation in China but also provided the guidance of practical operation for how to achieve a successful approval for your products entry into the Chinese medical device market.
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Executive Summary
The Chinese medical device market is one of segment market of the most growth potentiality, which is attracting more and more overseas medical device manufacturers and producers to penetrate such market. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB (about 57 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind the United States.
However, China’s regulatory framework for medical devices is undergoing radical changes. China’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 12, 2014, and it has come into force as of June 1, 2014. China Food and Drug Administration issued the latest “Measures for the Administration of Medical Device Registration”, and it has come into force as of October 1, 2014. The overseas medical devices exporting into China market should be subject to administration of overall new regulations since October 1, 2014.
The Chinese administration system for medical device registration undergone significant changes. Chinese authorities have begun to strengthen the supervision and administration of its medical device market. To strictly examine and approve the application dossiers for oversea medical device registration in China has become as the key threshold of oversea medical device exporting into China. The Chinese approach to administer medical device registration is unique. The application and approval process, clinical evaluation and clinical trial, the requirements for application dossiers are distinct from in U.S. and EU countries.How do you in compliance with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How to seize a bigger Chinese medical device market? The preparation of application dossiers compliance with overall new regulations becomes as the key for oversea medical device entry into Chinese medical device market. The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative medical device market, and cause trouble for your business smoothly in China.
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China’s regulatory framework for medical devices is undergoing radical changes. China’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 12, 2014, and it has come into force as of June 1, 2014. China Food and Drug Administration issued the latest “Measures for the Administration of Medical Device Registration”, and it has come into force as of October 1, 2014. The overseas medical devices exporting into China market should be subject to administration of overall new regulations since October 1, 2014.
The Chinese administration system for medical device registration undergone significant changes. Chinese authorities have begun to strengthen the supervision and administration of its medical device market. To strictly examine and approve the application dossiers for oversea medical device registration in China has become as the key threshold of oversea medical device exporting into China. The Chinese approach to administer medical device registration is unique. The application and approval process, clinical evaluation and clinical trial, the requirements for application dossiers are distinct from in U.S. and EU countries. How do you in compliance with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How to seize a bigger Chinese medical device market? The preparation of application dossiers compliance with overall new regulations becomes as the key for oversea medical device entry into Chinese medical device market. The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative medical device market, and cause trouble for your business smoothly in China.
Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition) not only provided a comprehensive and thorough knowledge of the overall new requirements of application dossiers for medical device registration or recordation in China but also provided the guidance of practical operation for how to achieve a successful approval for your products entry into the Chinese medical device market.
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