Pakistan Medical Device Registration

Regulatory Authority

Medical Devices and Medicated Cosmetics Division, Drug Regulatory Authority of Pakistan

Drug Regulatory Authority of Pakistan (DRAP) is responsible for providing effective coordination and enforcement of The Drugs Act, 1976 (XXXI of 1976) and to bring harmony in inter-provincial trade and commerce of therapeutic goods.

Therapeutic goods regulated by the DRAP include:

Pharmaceutical and biological drugs for human or veterinary use,
Medical Devices and Medical Cosmetics
Health & OTC (non-drugs) also known as alternative medicines such as:
- Ayurvedic
- Chinese
- Unani
- Homeopathy
- Nutritional products
- Food supplements for human beings, animals

DRAP ensures that therapeutic goods, approved and available in market, meet prescribed standards of quality, safety and efficacy. The regulatory functions performed by DRAP include registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of biologicals etc.

Link for Regulatory Authority

https://www.dra.gov.pk/

Local Regulation

https://www.dra.gov.pk/about-us/legislation/acts/

What is a Medical Device?

Medical devices include any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings or animals for one or more of the specific medical purposes of—

Diagnosis, prevention, monitoring, treatment or alleviation of disease;
Diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
Investigation, replacement, modification or support of the anatomy or of a physiological process;
Supporting or sustaining life;
Control of conception;
Disinfection of medical devices; or
Providing information by means of in-vitro examination of specimens derived from the human body,

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means.

Classification of Medical Devices

Class	Risk-Level	Example
Class A	Low	Tongue depressors/ disposable masks
Class B	Low-Moderate	Hypodermic Needles / suction equipment
Class C	Moderate-High	Lung ventilator / bone fixation plate
Class D	High	Heart valves / implantable defibrillator

Listing or Registration Requirements

Importers must first obtain an Establishment License to import medical devices from DRAP.
The applicant must submit online application
Submission of online application is followed by the submission of the hardcopy of the application to Medical Devices Division, DRAP on Form-2.
Once the complete application is received in DRAP, the storage premises may be visited by the panel constituted by DRAP.
The Competent Authority to grant License is Medical Device Board (MDB)

Documents Required for Pakistan Medical Device Registration

Complete description of the medical device with intended use;
Explanation of novel features, if any;
Indications that the device will diagnose, treat, prevent, cure or mitigate, Contraindications, Warnings to inform on specific risk or hazard that a user needs to know before using the medical device
Sample of labels on the medical device and its packaging
Instructions for installation and maintenance, if applicable
Any information and instructions given to the patient, including instructions for any procedure the patient is expected to perform, if applicable.
Promotional material and product brochures.
Sample of labels on the medical device and its packaging
Information on validation for medical devices with sterile or with measuring function, where applicable
Provide complete documentation related to the manufacturing and quality control processes.