All medical devices are regulated by the Medical Devices and Medicated Cosmetics Division, Drug Regulatory Authority of Pakistan (DRAP)
Medical Device Definition
There is no official "medical device definition." Rather, there are multiple definitions given as "active medical device," "active device intended for diagnosis," "active therapeutic device," "adultered medical device," "counterfeit medical device," "custom-made medical device," "implantable medical device," "invasive medical device," "life supporting or life sustaining medical device," "medical device for self-testing or self-administration," "misbranded medical device," "special access medical device," "spurious medical device," "substandard medical device," and "surgically invasive medical device" (Medical Devices Rules, Ch. I, Art 2).
Classification of Medical Device
||Simple wound dressings, cotton wool, syringes without needles, urine collection bottles, compression hosiery, examination gloves
||Non-medicated impregnated gauze dressings, tubes used for blood transfusion, urinary catheters
||Dressings for chronic ulcerated wounds, dressings for severe burns, blood bags
Angioplasty balloon catheters and related guidewires,
dedicated disposable cardiovascular surgical instruments, breast implants
||Registration Cost: USD $1440-$3634 depending on type of device and
|Post Market Surveillance
||The manufacturer must establish, maintain and implement a post-market surveillance system. Medical Devices Rules, Ch. II, Part II, 6.