A business example
A supplier markets a testing instrument for research use and then proposes diagnostic claims for use with patients.
Intended purpose
Record the use and claims proposed for the product.
Classification review
Assess the device framework against those intended uses and specifications.
Market documentation
Align labelling, permissions and supporting evidence with the assessed product.
What this shows
Changing the claims can change the regulatory assessment. Calling the item laboratory equipment does not settle its position.
What it is often confused with
Marketing a product as wellness equipment does not alone decide its regulatory classification.
What to look at in your business
Document intended use, product claims and the regulatory classification basis.
Context and further reading
CDSCO: medical-device definition, S.O. 648(E). The notification identifies intended medical purposes and the distinction from products whose primary action is pharmacological, immunological or metabolic. Apply the complete definition to the product; this entry is a plain-language introduction. Reference checked 2 October 2026.
Kosha.Services · Updated 2 October 2026