Companies introducing new medical devices often call us for help answering these questions:
- Is our product a medical device, cosmetic, medicinal or combination product?
- What is the medical device classification of our product?
- What are the compliance requirements for our medical device?
- Can clearance, approval, or registration in one market expedite registration in another market?
- Is there a suggested regulatory strategy to approach our markets of interest?
We have had experience with thousands of medical device and IVD products and therefore can help you address these questions.
Determining whether a product is a drug or device becomes especially critical in the case of combination devices, or with products that could be regulated as a pharmaceutical based on the claims and intended use defined by the manufacturer. Improper classification, slight changes to formulations, or claims of performance which cannot be substantiated by clinical data can have a staggering impact on the regulatory approval process and its associated costs.
Emergo can help determine if your product can be classified as a device and in the case of combination products, consult with you to determine the most efficient path to regulatory approval.
As part of the process, we will review the technical product information, assist in reviewing the intended use and claims for your device, and communicate with the appropriate Ministry of Health before, during and after the application process.