Only products which appear in this database listing may be offered for general marketing purposes in canada. A class i medical device are those devices that have a low to moderate risk to the patient andor user. One way is through health canadas medical devices special access program. It is clear how these two classes of devices interact very differently with the host. A medical device establishment licence mdel is required by class i. Manufacturers of class i devices in canada must apply for a medical device establishment license mdel unless they solely import or distribute though a licensed distributorimporter. A surgical gown is a personal protective garment intended to be. The mdsap as an arbiter in health technology selection, playing an.
Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. For class ii, iii, and iv devices, issued licenses will be posted on the health canada website, and copies of your mdl will be emailed to you. General controls are the basic authorities of the medical device amendments that provide the fda with the means of regulating devices to ensure their safety and effectiveness. Class i medical devices do not require a medical device licence and are monitored by the health products and food branch inspectorate compliance and enforcement through establishment licensing. If a device falls into a generic category of exempted class i devices, a premarket notification application and fda clearance is not required before marketing the device in the u. En 455021 which is for active implantable medical devices, and iec 62304 for medical software. Whats the difference between a class i medical device and. The medical devices special access program in canada. The safety and effectiveness evidence required to support a medical device licence application is proportional to the risk of the device, which is determined by applying the classification rules for medical devices detailed in schedule 1 of the regulations. The medical devices regulations regulations utilize a riskbased approach to regulating products within its scope. Clinical evidence for medical devices world health organization.
Global harmonization task force ghtf for medical devices along with the us, canada, the european union and japan. Medical device as defined in section 1 of the medical devices. We also can help you register your medical devices with health canada. Devices regulations noncorrective contact lenses and labelling of class. The device classification regulation defines the regulatory requirements for a. Some of the highlights of these guidelines are given in table 1. The term medical devices, as defined in the food and drugs act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition additional information on how medical devices are approved and authorized in canada is available on the fact sheet safe medical devices in canada.
For class i devices, approved applications will be posted on the health canada website and your mdel certificate will be emailed to you. Although class i devices do not require a licence, they are monitored through establishment licences. Medical device establishment licensing and fees disclaimer this document does not constitute part of the food and drugs act or its regulations, and in the event of any inconsistency or conflict between the act or regulations and this document, the act or the regulations take precedence. This guidance applies to manufacturers of class i medical devices, including accessories but excluding devices intended for clinical investigation and custom. Medical device industry an overview sciencedirect topics.
As of september 14, 2016, this document supersedes blue book memorandum. A medical device is any device intended to be used for medical purposes. Health canada regulatory approval process for medical devices. Conformity assessment for class i low risk medical devices is self. Regulatory control increases from class i to class iii. Press releases, patents, book chapters and nonenglish material were also excluded. The medical device industry in canada consists of firms that produce a wide range of products used for. In order for medical devices to be legally marketed sold in the united states, they are required to be cleared or approved by the fda unless it is 510 k exempt. Medical devices are classified into class i, ii, and iii. This guidance applies to manufacturers of class i medical devices, including accessories but excluding devices intended for. Medical devices active licence listing mdall canada. Use of international standard iso 109931, biological. The medical devices bureau of health canada recognizes four classes of.
From 1st of may 2010, supply of unregistered class b, c and d devices will be prohibited. Current status of the regulation for medical devices ncbi. Index to assist manufacturers in verifying the class of medical devices. The mdsap as an arbiter in health technology selection, playing. Determine the classification of your medical device according to. Class iia devices include hearing aids and diagnostic ultrasound equipment. The regulatory requirement for different classes of medical devices is given in table 3. Changes to premarket assessment requirements for medical devices pdf, 1 mb. Prior to selling a device in canada, manufacturers of class ii, iii and iv devices must obtain a medical device licence. A surgical gown is regulated by the fda as a class ii medical device that requires a 510k premarket notification.