Medical Device Regulation in Canada
In America, there are thousands of manufacturers of medical devices that must get through a wall of FDA regulations, as well as constantly having to deal with certification services. Make sure that you are fluent with the Healthcare Products Regulatory Agency, or MHRA, when dealing with you product being sold in Europe. The Standard’s Council of Canada under the Canadian Medical Devices Conformity Assessment System or CMDCAS is a company that you may want to keep in mind, as well as Health Canada. If you are going to be trying to sell your product on the market in Canada, they have the set of rules you must follow.
Recognition of Use of Standards under the Medical Devices Regulations
By following the Recognition and Use of Standards under the Medical Devices Regulations, you can provide guidance for the manufacturers. The use of standards demonstrates compliance with the Safety and Effectiveness Requirements as well as the labeling requirements of the Canadian Medical Devices Regulation. This bit of guidance will apply on applications for new and amended medical device licenses and applications for investigational testing.
Label Requirements
There are certain label requirements, as well as safety and effectiveness requirements, that all the medical devices in Canada must meet. Because the questions were stated in such general ways, Health Canada, as well as manufacturers, will frequently need to clearly define criteria for figuring out whether a medical device meets requirements.
Health Canada Beliefs
Health Canada believes that conforming and recognized medical device standards, in whole or in part, can provide a level of assurance of safety and effectiveness for those aspects of medical devices addressed by the standard. Not all devices, or elements of devices, contribute to safety and effectiveness. Health Canada has recently partnered up with Global Harmonization Task Force (GHTF) and the Regulations help you participate in an international alarm system.
Improve Consistency
By using recognized standards, you can improve the consistency of an interpretation of the Regulations. Conforming with recognized standards may not always be a basis for a regulatory decision. In sticking with Health Canada, more efforts will be made to bring everything together. By using international standards whenever possible, you will reduce regulatory obstacles and allow for safe, effective, quality products to enter international markets quickly.
Clinical Trial Application
Manufacturers can now submit a clinical trial application and ignore Class II, III, and IV devices. As long as the life, health, or safety of patients is not harmed, this is a good route to go. A formal authorization is not required to use a Class I device in clinical tests. The devices must be labeled as “for investigational use only”. The Special Access Program allows for health care professionals to apply for authorization to use medical devices that are not licensed yet as well. If conventional therapy has failed, is unavailable, or is unsuitable, this may be an opportunity to create miracles.
Future of Medical Regulations
Recently, the Progressive Licensing Project was initiated to develop a system for drug regulation, in the future. You can start with a new framework that provides an opportunity for discussion with Canadians regarding drug licensing. The Medical Devices Program Strategic Plan that was put together between 2007 and 2012. When building for the future, it helps to define your future direction. Emphasis to commitment in improving your work environment and making sure that you strategically manage your plan is vital to success.
Canada is different from America when it comes to approving and not approving medical devices for patient use. They have their own companies that make the final decisions and have different requirements that make the decisions permanent.
Recognition of Use of Standards under the Medical Devices Regulations
By following the Recognition and Use of Standards under the Medical Devices Regulations, you can provide guidance for the manufacturers. The use of standards demonstrates compliance with the Safety and Effectiveness Requirements as well as the labeling requirements of the Canadian Medical Devices Regulation. This bit of guidance will apply on applications for new and amended medical device licenses and applications for investigational testing.
Label Requirements
There are certain label requirements, as well as safety and effectiveness requirements, that all the medical devices in Canada must meet. Because the questions were stated in such general ways, Health Canada, as well as manufacturers, will frequently need to clearly define criteria for figuring out whether a medical device meets requirements.
Health Canada Beliefs
Health Canada believes that conforming and recognized medical device standards, in whole or in part, can provide a level of assurance of safety and effectiveness for those aspects of medical devices addressed by the standard. Not all devices, or elements of devices, contribute to safety and effectiveness. Health Canada has recently partnered up with Global Harmonization Task Force (GHTF) and the Regulations help you participate in an international alarm system.
Improve Consistency
By using recognized standards, you can improve the consistency of an interpretation of the Regulations. Conforming with recognized standards may not always be a basis for a regulatory decision. In sticking with Health Canada, more efforts will be made to bring everything together. By using international standards whenever possible, you will reduce regulatory obstacles and allow for safe, effective, quality products to enter international markets quickly.
Clinical Trial Application
Manufacturers can now submit a clinical trial application and ignore Class II, III, and IV devices. As long as the life, health, or safety of patients is not harmed, this is a good route to go. A formal authorization is not required to use a Class I device in clinical tests. The devices must be labeled as “for investigational use only”. The Special Access Program allows for health care professionals to apply for authorization to use medical devices that are not licensed yet as well. If conventional therapy has failed, is unavailable, or is unsuitable, this may be an opportunity to create miracles.
Future of Medical Regulations
Recently, the Progressive Licensing Project was initiated to develop a system for drug regulation, in the future. You can start with a new framework that provides an opportunity for discussion with Canadians regarding drug licensing. The Medical Devices Program Strategic Plan that was put together between 2007 and 2012. When building for the future, it helps to define your future direction. Emphasis to commitment in improving your work environment and making sure that you strategically manage your plan is vital to success.
Canada is different from America when it comes to approving and not approving medical devices for patient use. They have their own companies that make the final decisions and have different requirements that make the decisions permanent.