- Recommendations for revascularisation in coronary artery disease patients
There have been several studies into the impact of completeness of revascularisation in recent years, yet few clear recommendations are available on the likely clinical outcomes. (September 03, 2010)
- Final meaningful use rules: What radiologists need to know
On July 13, U.S. physicians and hospitals received their marching orders on how to receive federal incentive payments for adopting electronic medical records. But the question remains: What does this mean for radiology? (July 30, 2010)
- Meet Phannie, NIST's Standard 'Phantom' For Calibrating MRI Machines
Magnetic resonance imaging (MRI) a widely used medical tool that relies on magnetic fields and radio waves to visualize the body's internal structures, especially soft tissues may soon become even more useful. (May 18, 2010)
- FDA: How to Market Your Device
One of the most difficult aspects of getting a medical device to market is KNOWING WHERE TO BEGIN i.e., what are the steps for marketing and in what order they are to be taken. Essentially, medical devices are subject to the general controls of the Federal Food Drug & Cosmetic (FD&C) Act which are contained in the final procedural regulations in Title 21 Code of Federal Regulations Part 800-1200 (21 CFR Parts 800 - 1299). (August 14, 2009)
- FDA:Overview of Device Regulation
FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. (August 14, 2009)
- CCC Certification System of Class III Medical Devices
Regulations for the Supervision and Administration of Medical Devices' provide mandatory safety certification system for part class III medical devices in China. Specific product directory in it is set down by State Food and Drug Administration and General Administration of Quality Supervision, Inspection and Quarantine of China. (August 04, 2009)
- Overview of China's regulatory process for medical devices
Determine the classification of your device using the State Food & drug Administration (SFDA) classification chart. (July 30, 2009)
- Introduction of SFDA Accredited Laboratories for Medical Device Testing
Beijing Medical Device Quality Supervision and Inspection Center (July 29, 2009)
- Preparations on China Medical Device Registration for Class II and Class III Products
Application form for registration of medical devices produced within our national borders;
Qualification certificate of medical device production enterprise:
Include a copy of production enterprise license, a copy of business license, as well as the applied product should be within the production contents checked and ratified in the production enterprise license; (July 29, 2009)
- Preparations on China Medical Device Registration for Class I Products
Production of Class I medical devices is examined and approved, and granted production registration certificate by Drug Administration of government of the city set up with districts. The production enterprises of Class I medical devices within our national borders are directly approved for production registration. (July 29, 2009)
- Provisions for Clinical Trials of Medical Devices
The Provisions for Clinical Trials of Medical Devices were passed by the State Food and Drug Administration at the administration affairs meeting on December 22 of 2003, are hereby promulgated and shall go into effect as of April 1,2004. (July 29, 2009)
- CCC Mark - Your Key to Chinese Market !
Based on relevant laws and regulations covering product safety licensing and product quality certification so as to improve and enhance regulatory functions (July 28, 2009)
- Overview of China Medical Device Registration
The information contained in this profile is intended for basic market planning. While these profiles are updated periodically, many regulatory systems are subject to change. Companies are strongly encouraged to contact in-country representatives who are familiar with the most current regulatory environment.
Translations of laws and regulations are unofficial. (July 28, 2009)
- Provisions for Medical Device Classification
The Provisions for Medical Device Classification were passed by the State Drug Administration at the administration affairs meeting on February 17 of 2000, are hereby promulgated and shall go into effect as of April 10, 2000 (July 28, 2009)
- Regulations for the Supervision and Administration of Medical Devices
These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety. (July 28, 2009)
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