Regulatory Affairs · Short notes

Medical Devices and Health Products: Short Notes & Cheat Sheet

How Pakistan regulates medical devices, diagnostics, nutraceuticals and alternative medicines under DRAP's rules.

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Short notes

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Device risk classes

Risk to patientClass ALowBandagesClass BLow–moderateNeedlesClass CModerate–highVentilatorsClass DHighImplants
The higher the class, the more evidence and oversight the regulator requires.

Medical devices

  • Medical devices are regulated by DRAP under the Medical Devices Rules 2017.
  • Devices act mainly by physical means; examples include syringes, stents, glucose meters and implants.
  • Classification is risk-based, from Class A (low risk, e.g. bandages) to Class D (high risk, e.g. implantable cardiac devices).
  • In-vitro diagnostics such as rapid HIV tests and glucose strips are regulated too.
  • Post-market surveillance covers incident reporting, field safety notices and recalls.

Alternative medicines and health products

  • Nutraceuticals, food supplements and Unani, Ayurvedic, homeopathic and herbal medicines are enlisted under the Alternative Medicines and Health Products (Enlistment) Rules 2014.
  • Manufacturing premises need licensing, and labelling and claims are controlled.
  • Products claiming to cure serious diseases without evidence face regulatory action.
  • Medicated cosmetics with active ingredients fall under DRAP oversight.

Borderline and combination products

  • The primary mode of action decides whether a product is regulated as a drug or a device.
  • Drug-eluting stents and pre-filled syringes are common combination products.
  • Software intended for diagnosis or treatment can itself be a medical device (SaMD).

Cheat sheet

High-yield facts in one place. Cover the right-hand column and test yourself.

Device risk classes

ClassExample
A (low)Non-sterile bandages, tongue depressors
B (low–moderate)Hypodermic needles, suction equipment
C (moderate–high)Ventilators, bone fixation plates
D (high)Heart valves, implantable defibrillators

Product → framework

ProductRules
Medical devices and IVDsMedical Devices Rules 2017
Nutraceuticals, herbal, Unani, homeopathicAlternative Medicines and Health Products (Enlistment) Rules 2014
Clinical trialsBio-Study Rules 2017
Safety monitoringPharmacovigilance Rules 2022
DrugsDrugs Act 1976 and DRAP Act 2012

Memory aids

A to D = Ascending Danger
Device classes rise in risk from A (lowest) to D (highest), with stricter controls.

Exam traps

  • A glucose meter is a device; insulin is a drug.
  • Herbal products are enlisted, not exempt from regulation.
  • Combination products follow the rules for their primary mode of action.

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