Sector Overview
Drugs and medical devices need special registration with the competent authority before market entry, subject to strict quality and safety standards accounting for their direct impact on patient health.
Pharmaceutical and medical distribution contracts carry special terms related to cold chain and storage, and product responsibility when safety of the product is affected.
Regulatory Framework
This sector falls under drug and medical device registration regulations issued by the competent authority, which set quality and safety standards.
How We Work With This Sector
We review registration requirements for the pharmaceutical or medical product, and help draft distribution contracts accounting for this sector's safety standards.
Who We Work With in This Sector
Pharmaceutical or medical device companies needing their product registration licenses reviewed.
Pharmaceutical and medical distribution companies needing contracts accounting for safety standards.
We notice that some new medical distribution companies underestimate the actual time needed to register a new medical product, particularly when the product needs additional testing different from a similar product previously registered, and we recommend reviewing the actual requirements for each product individually rather than assuming a uniform timeline for all products within the same general category.
Related Services for This Sector
This connects with our specialized sector services, coordinated with our healthcare and life sciences expertise.
For product liability over any defect, this connects with our product liability and hidden defects service.
Common Questions
Do you review drug registration licenses?
Yes, we review these requirements carefully given the strictness of quality and safety standards required in this sector.
Who bears responsibility for a defect in a pharmaceutical or medical product?
This depends on the source of the defect and distribution contract terms, and we review this specifically to determine responsibility.