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. The document is intended to assist all parties involved in operations with medical devices in maintaining compliance with applicable requirements.
Private Label Medical Devices in General
The scope of the document covers applications for both new licenses and amendments thereto for private label medical devices assigned to the Classes II, III and IV in accordance with the risk-based classification.
The private label concept covers cases when the entity marketing medical devices under its own name actually has limited or no control over the manufacturing process. According to the definition provided in the guidance, the manufacturer is deemed a “private label” in case if the activities the general definition of the medical device manufacturer includes are being performed on its behalf by a third-party manufacturer. In particular, the sphere of responsibility of the manufacturer includes “designing, manufacturing, assembling, processing, labeling, packaging, refurbishing or modifying the device”. Thus, the guidance distinguishes the concepts of the “original manufacturer” – one that actually manufactures the medical device, and the “private label manufacturer” as one that places the device on the market under its own name or trademark.
Private Label Application Requirements
First of all it is important to mention that the license for the private label medical device could be obtained only after issuing the appropriate medical device license for the original manufacturer. The same procedure and order should be applied for any changes to the device: private label manufacturer is allowed to submit an application for changes only after the appropriate changes have been approved by the regulating authority upon the application submitted by the original manufacturer.
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. Each application also requires a medical device license fee form.
An application for a new medical device license for a private label medical device should contain the following information:
- Name of the private label medical device that would be indicated on the labeling. It should include the information on the medical device family, group family or system.
- Details about the private label manufacturer, including the name, address, company registration number of the manufacturer and contact person`s details (name and title, phone number, postal and email addresses). The details provided by the applicant in this section would be used for further correspondence, and also for licensing and financial purposes.
- Correspondence address for the regulatory purposes if it is different from the address indicated in the previous section (for example, in case if the applicant is an authorized representative of the private label manufacturer).
- Details about the original manufacturer, including the name and address of the original manufacturer itself and its contact person.
- Details on the device manufactured by the original manufacturer, including the device name, class of the device in accordance with the risk-based classification, the number of the license issued by the Canadian healthcare regulating authority, the number of the quality systems certificate and the name of its registrar.
- Indication of the type of license application (e.g. a single medical device, medical device family, medical device group, medical device group family, system or test kit).
- Identifier of the private label medical device (bar code, catalog, model or part number).
- Attestations section to be filled by a senior official of the private label manufacturer.
An application for a new medical device license should be accompanied by the sample of labeling and other information materials supplied with the device, including the instructions for use. The applicant should also submit the Declaration of Compliance with the Medical Devices Regulations signed by a senior official of the private label manufacturer, and the Letter of Authorization signed by a senior official of the original manufacturer.
Health Canada Application for Amendment
Besides the requirements for the application for a new medical device license, the document issued by the Health Canada also provides recommendations on submitting the application for the amendments to the existing medical device license. It is important to mention that each amendment requires a separate application form to be filed by the private label manufacturer. According to the guidance, the application for a medical device license amendment for a private label medical device should contain the following information:
- Indication of the nature of amendment (e.g. change in the name of the private label manufacturer, change in the name of the device, etc).
- Details on the private label medical device in question, including its name, class in accordance with the risk-based classification and the appropriate license number.
- Details on changes to the name and/or address of the private label manufacturer with the descriptions of reasons.
- Details on changes to the name of the device, also with the description of reasons.
- Amendments to the identifiers of the device.
- Attestations section.
Health Canada Additional Documents
To assist medical device manufacturers in maintaining compliance with applicable requirements, the Health Canada also provides the templates of additional documents to be provided by the manufacturer together with the application for a new medical device license or amendments to existing one for a private label medical device.
The first additional document to be provided is the Declaration of Compliance with the Medical Devices Regulations. In this document, the private label manufacturer applying for the license should provide the information about the device itself and the original manufacturer, and also to declare compliance with applicable requirements set forth by the Medical Devices Regulations, including the requirements on post-market surveillance, such as complaint handling, reporting and medical device recalls. The Declaration should be signed by an authorized senior official of the private label manufacturer applying for the license.
Another document to be provided in the course of the application process is the Letter of Authorization from the original manufacturer. The Letter should be provided on the letterhead of the original manufacturer. In this letter, the original manufacturer confirms the origin of the private label medical device in question and its compliance with applicable requirements. By this letter, the original manufacturer also authorizes the private label manufacturer to market the device under its own name or trademark. The Letter of Authorization should be signed by an authorized senior official of the original manufacturer.
Summarizing the information provided hereabove, the guidance document issued by the Health Canada provides detailed requirements for the applications for a new medical device license or amendments to the existing license for a private label medical device. The document also contains templates of the additional documents to be submitted by the private label manufacturer together with the appropriate application form.
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