Drug Regulatory Authority of Pakistan (DRAP)

The Drug Regulatory Authority of Pakistan (DRAP) is Pakistan's national authority for therapeutic goods, including medical devices and in vitro diagnostics. The Medical Devices Board within DRAP performs key licensing and registration functions. A manufacturer planning entry into Pakistan must address both establishment authorization and product registration.

What does DRAP do for medical devices?

DRAP administers medical device rules, licenses establishments, registers or enlists products, controls imports, conducts inspections, and oversees post-market safety and enforcement. The Medical Devices Board considers relevant applications. DRAP also publishes regulatory updates, safety communications, and online application resources.

How are medical devices classified in Pakistan?

Pakistan uses Classes A, B, C, and D, progressing from lower to higher risk. Classification affects whether a device follows enlistment or registration controls and determines the depth of the technical evidence. Intended purpose, invasiveness, duration of use, active functions, and IVD-specific rules can affect classification. Manufacturers should document the applied rule before selecting an application type.

Is a local importer required?

An overseas manufacturer generally works through a locally established importer that first holds the appropriate medical device establishment license. DRAP's official process states that an imported-device application proceeds after the importer obtains its establishment license. The local party then submits product applications through the Medical Devices Management System.

What is the DRAP application process?

A typical sequence is to qualify and license the local establishment, classify the product, assemble administrative and technical evidence, submit through the online MDMC system, respond to review questions, and maintain the authorization. The package can include manufacturer authorization, quality-system documents, labeling, device description, safety and performance evidence, market-history documents, and fees. Requirements increase with risk.

What must be maintained after registration?

The manufacturer and local license holder should track renewals, report applicable changes, maintain distribution and complaint records, fulfill vigilance duties, and cooperate with recalls or field safety corrective actions. Establishment-license maintenance and product status should be managed together so an expired or changed local license does not disrupt supply.

How can I verify DRAP requirements?

Use DRAP's official medical device application process and establishment licensing page. DRAP lists the toll-free number 0800-03727 for general contact.

Related Pakistan regulatory topics

See our Pakistan medical device registration overview for an end-to-end market pathway.