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From January 1st, 2003, a new medical device regulation, Canada medical device law is put into practice. All medical devices sold in Canada, no matter local or imported, should get the permission of Canada medical device competent department in Health Canada. Different from American FDA government, CMDCAS (Canadian Medical Devices Conformity Assessment System) registration law contains product registration and GMP certification, as well as the third party Notified Body CE certification in Europe and quality system certification of Canada government registration combine with the third party. The third party is referred to as the body which is recognized by CMDCAS. CMDCAS can be divided into 4 classes according to their risk: class one with the lowest risk, class four with the highest.
?.Benefits of the training ?. Training objects: ?.Training content 1. Sterilization medical device packing training Related standard regulations Common packing forms Basic principles and requirements Basic requirements of packing materials Basic performing experiment on packing system Effective design methods 2. Training on EO Sterilization confirm EO sterilization Introduction on EO sterilization Technique and regulation challenge Procedures on sterilization validation 3. Training on routine control ?.Training time and place: Time: September 2012 Place: Guangzhou, specific time is undetermined ?.Introduction of organizers Guangdong Medical Device Quality Supervision and Test Institute Medical Device Quality Management Committee, China Quality Association for Pharmaceuticals Osmunda Medical Device Consulting Organization
FDA is responsible for • Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled and that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective • Protecting the public from electronic product radiation • Assuring cosmetics and dietary supplements are safe and properly labeled • Regulating tobacco products • Advancing the public health by helping to accelerate product innovations • Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health