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Sep 5, 2017 · Published on September 5, 2017. Author: Pinky Mazumder. The Policy on Changes in Manufacturer’s name and/or Product Name (CMPN) applies to drug submissions to Health Canada where the manufacturer's and/or product’s name is being changed due to a merger, corporate restructuring, licensing agreement, or a buy-out.
Changes in Manufacturer’s Name and/or Product Name Health Canada Policy 2 Created March 24, 1998 Updated:June 2017 1. PURPOSE The purpose of this policy is to define the conditions and procedures for the administrative processing of drug submissions pertaining to a change in manufacturer’s name and/or product
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- Changes to manufacturing processes, facilities or equipment
- Changes to manufacturing quality control procedures
- Changes in design
- Changes to sterilization
- Changes to software
- Changes in materials for non in vitro diagnostic devices
- Changes in materials for in vitro diagnostic devices
- Changes to labelling
- Class III and IV amendments for compatible Class II devices
•Changes to manufacturing processes, facilities or equipment
•Changes to manufacturing quality control procedures
•Changes in design
•Changes to sterilization
•Changes to software
•Changes in materials for non in vitro diagnostic devices
For the purposes of this section, a manufacturing change impacts how a device is made, but does not intentionally change the device or its packaging and labelling material.
Examples of a manufacturing change would be:
•changes to the component formation process
•for example, from an extruded to a machined component
•altering manufacturing machine tolerances
•replacing equipment used to perform a manufacturing function
Changing or adding new testing or inspection activities for incoming materials, in-process materials and final products is not a significant change if the specifications or acceptance criteria have not been loosened and acceptance quality limits (AQL) have not increased. On the other hand, removing or modifying these activities where the result is that specifications or criteria are loosened or the AQLs are increased is a significant change.
Changes to quality control inspections or tests used to control the quality, purity or sterility of materials and devices that affect the specifications of the finished device or its components, including its packaging, are often considered significant. However, if adding or modifying the inspection or test method provides equivalent or improved assurance of reliability, then the modification is not significant. It must be reported at annual renewal, with applicable justification made to support this modification.
Examples include changes to the:
•test or inspection criteria
•test method
•parameter tested or inspected
Changes in design range from minor design specification or engineering changes to major changes in operating principles. All design changes must be evaluated, verified and validated according to the accepted procedures recorded in the quality management system.
Significant design changes can include modifications to the:
•device’s control mechanism
•device’s operating principles
•device’s design specifications
•device’s components or accessories
Changes that could affect the effectiveness of the sterilization process or the safety of a sterile device are significant.
The nature of sterilization is such that it is impossible to determine by inspection and testing if the device has been sterilized successfully. Medical devices are considered sterile if you can demonstrate a sterility assurance level (SAL) of 10-6 or better. The sterilization process must be verified and validated, and its performance routinely monitored.
Examples of significant sterilization changes are those where the:
•manufacturing process, environment or device material introduces an organism that is more difficult to kill compared to the challenge organism previously used in sterilization validation testing
•manufacturing process, environment or device material increases the bioburden above the maximum bioburden level previously validated in sterilization validation testing
•device design introduces a feature or alters existing features that result in a new worst case most-difficult-to-sterilize location for sterilization validation
Software can be embedded within a medical device or an accessory to a medical device or exist as software as a medical device (SaMD). Software is updated easily and frequently, and thus may undergo several changes during its lifecycle. Health Canada considers some of these changes to be significant.
Examples of significant software changes are those that:
•affect the function or performance specifications associated with the intended use of the device or the intended use of a compatible device whose function is controlled by the software
•introduce a new risk or modify an existing risk that could result in significant harm, including any unintended consequences
•create or necessitate a new risk control measure or a modification of an existing risk control measure for a hazardous situation that could result in significant harm
Examples of non-significant changes if none of the previous changes apply are those that:
A change in material type or formulation may affect the chemical, physical and/or electromagnetic properties of the material. A material change may also influence the device’s:
•manufacturing process
•for example, different equipment is required
•design specifications
•for example, device mechanical performance is altered
•biological safety and biocompatibility
There is a distinction between in vitro diagnostic devices (IVDDs) and other devices regarding material changes.
Material changes of an IVDD include those made to:
•critical components
•such as antigens, antibodies, primers, conjugates
•other reagents
•such as buffers
Labelling includes:
•user manuals
•patient labelling
•instructions for use
•labels affixed on the device
•other provided documents that include information about using the device
“Compatibility” is the ability of a device, when used with 1 or more other devices, to achieve the overall clinical purpose without the user having to modify or adapt any part of the combined devices.
An important requirement in demonstrating safety and effectiveness of medical devices that are to be used together is compliance with section 18 of the Medical Devices Regulations. Under section 18, a medical device intended to be used together with other medical devices must:
•be compatible with every other medical device with which it interacts and
•not adversely affect the performance of the medical devices used together
This requirement applies to compatible devices that reside on the same authorization and those that are authorized separately.
Refer to the following notice for the situation when the devices are authorized separately:
Feb 7, 2024 · Current status: Open. Opened on February 7, 2024, and will close to new input on April 22, 2024. Health Canada has updated the Guidance on how to interpret ‘significant change’ of a medical device. This guidance: helps manufacturers determine when a change made to a device is significant.
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