DRAP Pakistan Medical Device Registration

Medical devices in Pakistan are regulated by the Drug Regulatory Authority of Pakistan (DRAP) under the Medical Devices Rules, 2017 and subsequent amendments. DRAP oversees establishment licensing, product applications, import controls, market surveillance, and safety actions. Manufacturers should use the official DRAP medical device application guidance to confirm the current forms, fees, and portal requirements before filing.

Pakistan medical device classification

Pakistan uses four risk classes: Class A for the lowest-risk devices through Class D for the highest-risk devices. Classification depends on intended use, duration of contact, invasiveness, whether the device is active, and the consequences of a failure. The class determines the application route and the depth of technical, clinical, and quality-system evidence DRAP expects. IVDs also follow a risk-based framework, so the correct classification should be documented before a submission is assembled.

Local establishment and applicant requirements

A manufacturer outside Pakistan normally works through a locally licensed importer or authorized representative. The Pakistan entity needs the appropriate DRAP establishment license for its activities before it can sponsor product applications or import devices. Manufacturer and site information, authorization letters, quality-system evidence, and proof of approval or free sale from relevant reference markets may be required depending on the product and route.

Commercial control should be addressed in the representation agreement. It should define access to the registration dossier, change-notification responsibilities, complaint and vigilance handling, renewal work, and how registrations can be transferred if the relationship ends.

Registration dossier and lifecycle

A typical file includes device descriptions, intended use, classification rationale, labeling and instructions for use, manufacturing-site details, ISO 13485 evidence, declarations or certificates of conformity, test reports, and clinical or performance evidence where applicable. DRAP may ask questions or request additional documentation during review.

Approval is not the end of the program. Import documentation, approved labeling, distribution records, complaints, adverse-event reporting, field safety corrective actions, and registration or license maintenance must stay aligned. Changes to the manufacturer, design, intended use, labeling, or quality system should be assessed before implementation to determine whether DRAP notification or approval is required.