Requirements for Medical Device Registration in Canada
Medical devices are used in the analysis, cure, improvement and prevention of a medical condition. A wide range of equipment fall under this category including thermometer, tongue depressor, surgical instruments, etc. In Canada, medical devices are regulated by Health Canada's Therapeutic Products Directorate. These are subject to the Medical Devices Regulations under the Food and Drugs Act.
But what exactly is the aim of the medical devices Regulations?
Its main goal is to ensure that the medical devices offered in Canada for sale are completely safe, efficient and meet virtually all quality standards. The devices offered should be of high quality and not cause any harm to the end user who comes in direct contact with them.
Let us discuss in detail some of the prominent requirements for a successful registration of medical devices in Canada. These include:
Device licensing
Some of the medical devices require a license before these can be sold in Canada. The Medical Devices Bureau of Health Canada has divided these devices into four classes based on the dangers associated with the use of these products, energy transmission risks, consequences of device breakdown, extent of invasiveness, etc. These include Class I, II,III, or IV devices.
The Class I devices causes very less risk and do not need any license. As far as the Class II devices are concerned, these need the manufacturer's statement of device safety and efficiency. On the other hand, Class III and IV devices cause a huge risk and thus require in-depth regulatory analysis before licensing and sale.
Quality standards
As per the medical devices regulations, Class II medical devices need to be manufactured under a quality standard set by the International Organization for Standardization. On the other hand, Class III and IV devices need to fulfill ISO standard dealing with both manufacturing and design standards.
Application Process
Health Canada staff reviews the licence applications. Once all the requirements are fulfilled, the licences are issued. These are some of the primary requirements that medical device manufacturers need to fulfill in order to get their devices registered in Canadian market. In this regard, they can take help from medical device consultants. A medical device consultant fulfills all necessary formalities on your behalf to help you launch you devices on a global level. Many consulting firms have been emerged these days that have been playing an important role in introducing medical products at an international level.
But what exactly is the aim of the medical devices Regulations?
Its main goal is to ensure that the medical devices offered in Canada for sale are completely safe, efficient and meet virtually all quality standards. The devices offered should be of high quality and not cause any harm to the end user who comes in direct contact with them.
Let us discuss in detail some of the prominent requirements for a successful registration of medical devices in Canada. These include:
Device licensing
Some of the medical devices require a license before these can be sold in Canada. The Medical Devices Bureau of Health Canada has divided these devices into four classes based on the dangers associated with the use of these products, energy transmission risks, consequences of device breakdown, extent of invasiveness, etc. These include Class I, II,III, or IV devices.
The Class I devices causes very less risk and do not need any license. As far as the Class II devices are concerned, these need the manufacturer's statement of device safety and efficiency. On the other hand, Class III and IV devices cause a huge risk and thus require in-depth regulatory analysis before licensing and sale.
Quality standards
As per the medical devices regulations, Class II medical devices need to be manufactured under a quality standard set by the International Organization for Standardization. On the other hand, Class III and IV devices need to fulfill ISO standard dealing with both manufacturing and design standards.
Application Process
Health Canada staff reviews the licence applications. Once all the requirements are fulfilled, the licences are issued. These are some of the primary requirements that medical device manufacturers need to fulfill in order to get their devices registered in Canadian market. In this regard, they can take help from medical device consultants. A medical device consultant fulfills all necessary formalities on your behalf to help you launch you devices on a global level. Many consulting firms have been emerged these days that have been playing an important role in introducing medical products at an international level.
