Guidance on regulating medical devices manufactured from or incorporating viable or non-viable animal tissue or their derivative(s): Reduced licence amendment requirements

This page concerns reduced requirements for licence amendments in which animal materials or their derivatives are not being introduced into the device for the first time.

Medical device amendment applications may include more condensed and focused documentation to support an application for a medical device licence amendment. Include this information if you are requesting:

• a change in source of animal tissues or their derivatives, but not a change in the species or
• the addition of a new abattoir in the same geographical region as other currently approved abattoirs

Licence amendment for a change in source of animal tissues or their derivatives - adding a new abattoir in a new geographical region

To add a new abattoir in a new geographical region, you must provide the following:

• name and address of supplier
• signed certification of abattoir inspection showing:
• quality control processes and procedures are in place to prevent contamination or cross-contamination with potential infective tissues
• disinfection and/or decontamination procedures are in place in the event of contamination, or equivalent*
• status (open or closed) of the herd or collection of organisms (if applicable)
• signed certification of animal country and residence of origin, or equivalent* (shall include country's BSE risk status)
• signed certification of veterinary inspection, which includes certification that the animals are fit for human consumption, or equivalent*
• validation that the incorporation or use of the newly sourced animal material does not negatively affect the device's performance
• updated risk assessment that considers any new biological (for example, introduction of new pathogens associated with the change in animal source) or biocompatibility risks
• including local host responses to the animal material (for example, pyrogenic, immunogenic and toxicological responses)

Licence amendment for the addition of a new abattoir in the same geographical region as other currently approved abattoirs

To add a new abattoir in the same geographical region as other currently approved abattoirs, you must provide the following:

• name and address of supplier
• signed certification of animal country and residence of origin, or equivalent* (shall include that country's BSE risk status)
• status (open or closed) of the herd or collection of organisms
• signed certification of abattoir inspection showing:
• quality control processes and procedures are in place to prevent contamination or cross-contamination with potential infective tissues
• disinfection and/or decontamination procedures are in place in the event of contamination, or equivalent*
• signed certification of veterinary inspection, which includes certification that the animals are fit for human consumption, or equivalent*

* If signed certifications of the animal country of origin, abattoir and veterinary inspection are not available when you submit your licence amendment application, you may provide items that reference these, such as:

• supplier check lists
• training activities
• verification testing and risk analysis (for example, audit reports)
• evidence of abattoir certification by regulatory inspections (for example, a list of government-inspected facilities)
• export certificates for a representative lot of animal tissue or derivatives (for example, veterinarian-signed USDA FSIS Form)

Licence amendment for changes to animal tissue or derivative specifications or design considerations

To make changes to animal tissue or derivative specifications or design considerations, you must provide:

• a clear description of the proposed specification or design changes
• a rationale describing all possible impacts of the proposed changes on the safety and effectiveness of the device
• evidence in the form of data and/or reports that show the changes do not negatively affect the safety and effectiveness of the device