Medical Device and its Regulations in

Pakistan
Medical devices cover a wide spectrum of products - ranging from those that are found in
hospitals and clinics such as x-ray machines and blood pressure machines, to those that are
commonly available in pharmacies/medical stores such as sterilized gauzes, thermometers,
condoms and pregnancy kits.

Do you know that contact lenses with refractive power are also medical devices? How you can
know if a product is a medical device and how can you use a medical device safely? Read on to
find out more.

WHAT IS A MEDICAL DEVICE?

A medical device is a product or equipment intended to diagnose, monitor or treat diseases, or as
a supportive aid for people with physical disability. While many medical devices such as x-ray
machines, dialysis machines, infusion pumps and cardiac pacemakers are used by doctors,
nurses, and other healthcare professionals to help them diagnose and treat patients in hospitals or
clinics, there are also a number of medical devices that are used by the patients, care givers and
public in the home setting. Examples of common medical devices that you may use in your daily
lives include wound dressings, digital thermometers, contact lenses and wound irrigation
solutions.

Products such as body toning equipment, magnetic accessories and massagers, are not medical
devices. These products are only intended for general well-being and do not prevent, diagnose,
treat or alleviate injuries or diseases.

Please exercise caution if such well-being products tout to treat serious or chronic illnesses e.g.
diabetes, hypertension, cancer. When in doubt, please seek advice from your family doctors.

HOW ARE MEDICAL DEVICES REGULATED IN PAKISTAN?

The Drug Regulatory Authority of Pakistan has a subdivision know as Medical Device and
Medicated Cosmetics Division that introduced the Medical Devices Regulations on 9th March,
2015 first time in the history of Pakistan and later on Medical Device Rules 2017 were notified
on 16th January, 2018 that repealed the Medical Device Rules 2015 and Medical Device Rules
2017 are applicable now, to ensure public and consumer have access to safe, effective and good
quality medical devices in Pakistan. These rules and regulations are effective since 16th January
2018.
PROCEDURE FOR OBTAINING MEDICAL DEVICE
ESTABLISHMENT LIC

CLASSES OF MEDICAL DEVICES

Medical devices are risk classified into four categories (Class A to D) based on their intended
use, with Class A medical devices of lowest risk and Class D, the highest. Complex, riskier
devices would require greater attention and review compared to simpler, safer products.
Medical Device & Medicated Cosmetics division of Drug Regulatory Authority of Pakistan
ensures the safety and access of medical devices used in Pakistan in three ways, through product
registration, dealer licenses and by monitoring the devices' use and sale. All medical devices are
subject to product registration prior to sale, with enlistment of Class A medical devices such as
wheelchair, sling bandage, non-sterile face masks and hot/cold pack.

In addition to product registration, Medical Device & Medicated Cosmetics (MD&MC) division
of Drug Regulatory Authority of Pakistan (DRAP) requires all importers, wholesalers and
manufacturers of medical devices to be licensed to ensure that marketed devices are consistently
safe, effective and of good quality. MD&MC division of DRAP also monitors the use of these
products by checking on products already in the market as well as working closely with
healthcare professionals, industry partners and other government agencies, to continuously
gather information on the use of these devices.

HOW CAN I REDUCE RISKS ASSOCIATED WITH MEDICAL

DEVICES?

DO
 Make sure that the device is suitable for use in your condition.

 Read and understand the instruction provided before using the device

 Keep and store the medical device in accordance to the instruction provided

 Always ask your doctor, nurse, therapist or pharmacist for advice if you any question
regarding the medical devices

 Stop using the device immediately if you experience any discomfort or injury

DON'T
 Forgo your prescribed medical treatent

 Buy from dubious sources e.g. Internet website, "fly-by-night" or makeshift stalls

 Buy medical devices with questionable claims such as:

 Emotive and sensational claims, such as 'miracle cure' and 'scientifically proven
breakthrough'

 Claims of treatment that is not available elsewhere

 Claims to cure a wide range of diseases and serious/chronic diseases (e.g. diabetes
mellitus hypertension, cancer)
 Promise of quick or painless cure

 Promise of no-risk, money-back guarantee