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The Classification Committee for Therapeutic Products has classified the types of combination products listed below, in accordance with the Policy on mixed products: drugs/medical devicesOctober 20, 1998. This list also included products that are not combination products but whose classification as a drug or medical device was difficult to determine.
The Program applies the following policy:
A mixed product is subject to either Medical Devices Regulations either to Food and Drug Regulationsaccording to the principal mechanism of action which enables it to exert the claimed effect or achieve the intended purpose. If the principal mechanism of action which enables it to exert the claimed effect or achieve the intended purpose is of a pharmacological, immunological or metabolic nature, the combination product is subject to the Food and Drug Regulationsunless this action is carried out in vitro, without reintroduction into the patient of a modified cellular substance, in which case it is subject to the Medical Devices Regulations. If the main mechanism of action which allows the alleged effect to be exerted or the intended goal to be achieved is not of a pharmacological, immunological or metabolic nature, but may be assisted in the exercise of this effect or the achievement of this goal by pharmacological, immunological or metabolic means, the mixed product is subject to the Medical Devices Regulations.
This list is not exhaustive, particularly due to the complexity and particular nature of mixed products. It should only serve as an indication for determining the status of mixed products. The list will be updated periodically.
A. Combination products classified as drugs
pre-filled syringes transdermal patches for the delivery of a drug implants the primary purpose of which is to deliver a drug dressings the primary purpose of which is to deliver a drug dental products impregnated with a drug, the primary purpose of which is to deliver a drug solutions for the treatment of red blood cells contrast media solutions for peritoneal dialysis alcohol swabs
B. Mixed products classified as medical devices
drug-coated materials, such as catheters, lead sensors or pacemaker probes drug-impregnated materials surgical dressings and barriers containing an antimicrobial agent dressings the primary purpose of which is to act as a barrier against pathogens bone cement containing an antibiotic novel bone fillers, e.g. collagen matrix containing bone morphogenic protein injectable collagen sodium hyaluronate nasal solution urea breath test (accessory of medical equipment) equipment for ex vivo photodynamic treatment of cells
C. Mixed products to which this policy does not apply and which must comply with both the Food and Drug Regulations and to Regulation on medical instruments
kits (e.g. epidural anesthesia kit containing medications and materials; first aid kit containing medications and materials)
Products to which neither Regulation applies
minimally manipulated fabrics
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What are the key factors that influence the classification of combination products?
Table of Contents
Understanding the Classification of Combination Products: A Comprehensive Guide
Introduction
The Classification Committee for Therapeutic Products has established a policy for the classification of combination products, which are products that consist of two or more components, such as drugs and medical devices. This policy, outlined in the Policy on Mixed Products: Drugs/Medical Devices, provides guidance on how to classify these products and determine whether they are subject to the Food and Drug Regulations or the Medical Devices Regulations.
What are Combination Products?
Combination products are products that combine two or more components, such as a drug and a medical device, to achieve a therapeutic effect. These products can take many forms, including pre-filled syringes, transdermal patches, implants, dental products, and dressings.
Classification of Combination Products
The classification of combination products is based on their principal mechanism of action, which is the primary way in which the product achieves its intended purpose. If the principal mechanism of action is pharmacological, immunological, or metabolic in nature, the product is subject to the Food and Drug Regulations. However, if the principal mechanism of action is not pharmacological, immunological, or metabolic, but may be assisted by these means, the product is subject to the Medical Devices Regulations.
Examples of Combination Products Classified as Drugs
The following combination products have been classified as drugs:
Pre-filled syringes
Transdermal patches for the delivery of a drug
Implants whose primary purpose is to deliver a drug
Dressings whose primary purpose is to deliver a drug
Dental products impregnated with a drug, whose primary purpose is to deliver a drug
Solutions for the treatment of red blood cells
Contrast media solutions for peritoneal dialysis
Alcohol swabs
Examples of Combination Products Classified as Medical Devices
The following combination products have been classified as medical devices:
Drug-coated materials, such as catheters, lead sensors, or pacemaker probes
Drug-impregnated materials
Surgical dressings and barriers containing an antimicrobial agent
Dressings whose primary purpose is to act as a barrier against pathogens
Bone cement containing an antibiotic
Novel bone fillers, such as collagen matrix containing bone morphogenic protein
Injectable collagen
Sodium hyaluronate nasal solution
* Urea breath test (accessory of medical device)
Importance of Classification
The classification of combination products is important because it determines which regulatory framework applies to the product. This, in turn, affects the product’s development, manufacturing, and approval process.
Conclusion
The classification of combination products is a complex process that requires careful consideration of the product’s principal mechanism of action. By understanding the policy and guidelines outlined in this article, manufacturers and developers of combination products can ensure that their products are classified correctly and comply with the relevant regulatory requirements.
Keywords: combination products, drug-device combination, medical devices, Food and Drug Regulations, Medical Devices Regulations, Classification Committee for Therapeutic Products.
– What are the main types of combination products and how are they classified?
Understanding the Classification of Combination Products: A Comprehensive Guide
Introduction
The classification of combination products is a crucial aspect of healthcare regulation, particularly in countries like Canada. The Classification Committee for Therapeutic Products has developed a policy to guide the classification of combination products, which are products that combine a drug and a medical device. In this article, we will delve into the key factors that influence the classification of combination products and provide a comprehensive guide to understanding this complex topic.
What are Combination Products?
Combination products are products that combine a drug and a medical device. These products can take many forms, including pre-filled syringes, transdermal patches, implants, and dental products impregnated with a drug. The classification of these products is crucial, as it determines which regulations they must comply with and how they are approved for use in patients.
Key Factors that Influence Classification
The Classification Committee for Therapeutic Products has established a policy to guide the classification of combination products. According to this policy, the classification of a combination product depends on its principal mechanism of action. If the principal mechanism of action is pharmacological, immunological, or metabolic in nature, the combination product is subject to the Food and Drug Regulations. However, if the principal mechanism of action is not pharmacological, immunological, or metabolic in nature, but may be assisted in its effect or purpose by pharmacological, immunological, or metabolic means, the combination product is subject to the Medical Devices Regulations.
Classification of Combination Products
The Classification Committee for Therapeutic Products has classified combination products into three categories:
A. Combination Products Classified as Drugs
Pre-filled syringes
Transdermal patches for the delivery of a drug
Implants, the primary purpose of which is to deliver a drug
Dressings, the primary purpose of which is to deliver a drug
Dental products impregnated with a drug, the primary purpose of which is to deliver a drug
Solutions for the treatment of red blood cells
Contrast media solutions for peritoneal dialysis
Alcohol swabs
B. Combination Products Classified as Medical Devices
Drug-coated materials, such as catheters, lead sensors, or pacemaker probes
Drug-impregnated materials
Surgical dressings and barriers containing an antimicrobial agent
Dressings, the primary purpose of which is to act as a barrier against pathogens
Bone cement containing an antibiotic
Novel bone fillers, e.g., collagen matrix containing bone morphogenic protein
Injectable collagen
Sodium hyaluronate nasal solution
Urea breath test (accessory of medical equipment)
Equipment for ex vivo photodynamic treatment of cells
C. Combination Products to which this Policy does not Apply
Kits (e.g., epidural anesthesia kit containing medications and materials; first aid kit containing medications and materials)
Products to which Neither Regulation Applies
Minimally manipulated fabrics
Conclusion
The classification of combination products is a complex process that requires careful consideration of the product’s principal mechanism of action. By understanding the key factors that influence classification, healthcare manufacturers and regulatory bodies can ensure that these products are classified correctly and comply with the relevant regulations. This comprehensive guide provides a valuable resource for anyone interested in learning more about the classification of combination products.
Keywords: combination products, classification, drugs, medical devices, Health Canada, policy, regulation, therapeutic products.
