The four classes
Under the Medical Device Rules, 2017, the Medical Device Board classifies devices into four risk categories. Class A represents the lowest risk or hazard; Class D the highest.
The logic is proportionality. A device whose failure would cause minor inconvenience is not regulated like one whose failure could kill a patient.
How class maps to real products
Classification depends on factors including invasiveness, duration of contact with the body, whether the device is active, and whether it is life-supporting.
Broadly: simple non-invasive items sit at the low end; short-term invasive and many active diagnostic devices sit in the middle; long-term implantables and life-supporting devices sit at the high end. The precise assignment for any given product must come from the regulatory determination, not from assumption.
Why it matters to a hospital buyer
Three practical consequences.
Documentation. Higher classes require more evidence. Budget time for it.
Lead time. A Class C or D device may take considerably longer to clear than a Class A consumable. Tender deadlines should reflect this.
Scrutiny. Higher-class devices attract more post-market attention — vigilance reporting, field safety notices, traceability obligations. Your supplier should be able to describe how they handle these.
A practical question to ask suppliers
"What is the declared risk class of this device in Pakistan, and can you provide the registration or enlistment evidence for it?"
A supplier who cannot answer quickly is a supplier who will struggle at customs or at audit.
Frequently asked questions
Which class is highest risk?
Class D represents the highest risk or hazard; Class A the lowest.
Who assigns the classification?
The Medical Device Board under DRAP, operating under the Medical Device Rules, 2017.