London, UK (PRWEB) August 27, 2014
China’s regulatory framework for medical devices is going through a period of dramatic changes. The country’s new leaders have admitted that the regulations for supervision and administration of medical equipment are far from being alongside 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” to try to completely change such imperfect status. The latest “Regulations on the Administration of the Instructions and Labels of Medical Devices”, “Measures for the Administration of Medical Device Registration”, “Measures for the Supervision and Administration of Medical Device Distribution”, “Measures for the Supervision and Administration of Medical Device Production” and “Measures for the Administration of IVD registration”, recently issued by the CFDA, will come into force this year on the 1st of October. The radical change of regulations on medical devices is forecast to bring foreign and international medical device makers the maximum opportunities and challenges.
To achieve a successful entry into this lucrative medical device market and know how to ensure smooth business operations in China, the medical device manufacturers, overseas and multinational, must have a deep understanding of the latest regulations on medical device registration in the country.
New study “Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)” developed by Access China Management Consulting is now available MarketPublishers.com.
Title: Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)
Published: August, 2014
Price: US$ 1,250.00
The research publication provides the latest regulations for imported medical device registration and the practical operation how to meet these regulations to guide overseas medical device makers and producers to achieve a successful approval for their products’ entry into China’s market for medical devices.
- Deep overview of the latest Chinese applicable regulations for imported foreign medical device registration and recordation.
- Review of the national regulations on medical devices which are undergoing remarkable changes.
- Look into the organisational structure of the country’s regulatory authorities for imported medical device registration and recordation.
- Valuable information on the Chinese approach for medical device registration as well as how to put it into practice.
- Examination of the most recent local regulations for application for imported medical product recordation (applicable to Class I imported foreign medical devices).
- The latest Chinese regulations for application and approval for imported medical device registration (applicable to Class II and II imported overseas medical devices).
- Detailed classification of Chinese medical devices.
- Review of the rights of human subjects and responsibilities of every party in clinical development for imported overseas medical devices in the country.
- Practical guidance for application of imported overseas medical device recordation.
- Practical guidance for application and approval of imported overseas medical device registration.
- Guidance for alteration registration and renewal registration of medical devices imported from abroad – from how to complete application documents to how to submit the required documents in stepwise manner.
- A complete set of full text in English of the latest Chinese regulatory requirements for the imported overseas medical device registration and recordation.
More new reports by the publisher can be found at Access China page.