Health Canada Private Label Medical Devices

Get a quote today. Health Canada the countrys regulating authority in the sphere of medical devices and other healthcare products has published a guidance document dedicated to the investigation of reported problems associated with medical devices.

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Private label medical device a medical device that is identical in every respect to a medical device manufactured by an original manufacturer and licensed by Health Canada except that the device is labelled with the private label manufacturers name address and product name and identifier.

Health canada private label medical devices. Get a quote today. The REP pilot expansion will be available to companies that are filing regulatory transactions in the IMDRF ToC format. Preferred Name Code For Health Canada Use Only.

Class I medical device manufacturer who intends to sell their medical devices directly to the user in Canada must obtain an MDEL. Exclusively for over 50s. In most cases under the current Canadian risk-based classification for medical devices ultrasonic diagnostic systems and transducers are Class III medical devices.

The Health Canada the Canadian authority responsible for medical devices regulation issued guidance dedicated to the application for a new license of making amendments to existing one for private label medical device. In order to apply for a new private label medical device license or for the changes to the existing private label medical device license the private label manufacturer should fill in and submit the appropriate forms that could be downloaded from the official website of the Health Canada. Exclusively for over 50s.

Private label medical device means a medical device that is identical in every respect to a medical device manufactured by an original manufacturer and licensed by Health Canada except that the device is labelled with the private label manufacturers name. Ad Reliable and durable medical equipment. The device licence is issued for a the device name on the label which may describe one device b an administrative grouping of devices sold for convenience under a single name or c a grouping of devices that carry the same generic name specifying the intended use of the devices.

Designed for your needs since 1889. Private Label for Medical Device Manufacturers Private-label products or so called private brands are products that are manufactured or provided by one company for offer under another companys brand name. The 1 Medical Device Establishment Licence MDEL required for Class I medical devices and the 2 Medical Device Licence MDL for all the other classes.

The application for such a license must include an agreement by the original manufacturer that they will be responsible for. For HC Class II III and IV devices a private label manufacturer must have an HC device license of their own to sell their device in Canada. Private label medical devices are currently exempt from Division 2 - Fees for the Examination of Medical Devices Licence Applications contained in Part 3 - Medical Devices Fees of the Fees in Respect of Drugs and Medical Devices Regulations.

Identifier for Private Label Medical Device bar code catalogue model or part number Corresponding Identifier for Medical Device Manufactured by Original Manufacturer bar code catalogue model or part number Corresponding Device ID as it appears on the Original Manufacturers Medical Device Licence. Health Canada Private Label Medical Device License applications. Collect and manage all ePRO data in one place.

The REP can be used for Class II III and IV regulatory activities such as Medical Device License MDL applications and amendments minor change amendments and private label applications and amendments. Get in touch with us today. Ad Get the healthcare you need without a wait.

However those intended to be in direct contact with the central nervous system or the central cardiovascular system are subject to a special exception. Ad ePRO software made for medical devices. The latest version of the document was issued in March 2011.

Each device including a system medical device group medical device family or medical device group family must have a name. Speak to a GP for advice reassurance even diagnosis. Application for a Medical Device Licence Amendment for a Private Label Medical Device 2020-04-01 Application for a New Medical Device Licence for a Private Label Medical Device 2020-04-01 Bed-related Entrapment and Fall Report Form 2008-03-17 Class II Medical Device Licence Amendment Application Form PDF fillablesaveable 247 K 2020.

There are two types of licenses issued by Health Canada. Improve patient engagement and your teams efficiency with SMART-TRIAL ePRO software. Therefore there are no fees associated with the examination of private label medical device applications or private label licence amendment.

Private-label goods are available in a wide range of industries from food to cosmetics to medical devices. Each application also requires a medical device license fee form. 25 yrs market expertise.

We manage the entire application process for Health Canada Private Label Medical Device License for Class I II III or IV medical or surgical device IVD POCT-NPT SaMD. The authority explicitly states that the document should not be considered part of legislation since it does. Speak to a GP for advice reassurance even diagnosis.

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