Pakistan Medical Device Regulations

Agency

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

International Classification	Examples	Risk Level
Class A	Simple wound dressings, cotton wool, syringes without needles, urine collection bottles, compression hosiery, examination gloves	Low
Class B	Non-medicated impregnated gauze dressings, tubes used for blood transfusion, urinary catheters	Low-Moderate
Class C	Dressings for chronic ulcerated wounds, dressings for severe burns, blood bags	High-Moderate
Class D	Angioplasty balloon catheters and related guidewires, dedicated disposable cardiovascular surgical instruments, breast implants	High

Premarket Approval Process

Conformity assessment procedure: prepare a declaration of conformity (DoC) and establish a Quality Management System (QMS) including proof of compliance with ISO 13485.

Prepare a common submission dossier template (CSDT) which includes classification and description of medical device, preclinical study information, clinical evidence, information about if device is novel or hazardous, and demonstrate conformity. CSDT shall be written in English.

The Medical Device Board (MDB) will then review dossier and grant registration.

Additional Information

Validity	Five years
Costs	Registration Cost: USD $1440-$3634 depending on type of device and
Local Testing	Not required
Clinical Studies	Required
Post Market Surveillance	The manufacturer must establish, maintain and implement a post-market surveillance system. Medical Devices Rules, Ch. II, Part II, 6.

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