Medical Device Classification Consulting
Companies introducing new medical devices often call us for help answering three questions:
- Is our product a medical device, cosmetic, pharmaceutical or combination product?
- What is the medical device classification of our product under the classification guidelines in the US, Europe, Japan, Canada, Australia or China?
- What are the compliance requirements for our medical device?
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 excessive claims of performance can have a staggering impact on the regulatory approval process and their associated costs.
Emergo Group can help determine if your product can indeed be classified as a device and in the case of combination products, consult with you to determine the most efficient path to regulatory approval with the US FDA, European Competent Authorities, Health Canada, China SFDA, Australian TGA or Japanese PMDA.
As part of the process, we will review the technical information on your products, 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.
Contact us today and let us provide a proposal to you for medical device classification consulting.
