AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES - PAKISTAN)

All Medical Devices must be registered with the Drug Regulatory Authority of Pakistan (DRAP) in order to be placed on the Pakistani market.

It is first necessary for the importer to obtain a special establishment licence for the import of devices and any components via online platform submission followed by paper submission to the Medical Device Board (MDB) of DRAP.

Upon completion, the importer forwards the product file to DRAP, also in electronic and paper format, which contains information on intended use, safety and efficacy, production process and quality control.

The DRAP performs specific evaluation activities on clinical and technical data and, in case of a positive outcome, issues the registration certificate.

APPLICANT

The appointment of an Authorised Representative (AR) in the territory is required, who is the applicant for registration with DRAP, responsible for importing products and in charge of post-market surveillance activities in the territory.

TIME AND COSTS

The establishment licence at the expense of the Authorised Representative requires the payment of an initial fee of $335 to be paid by the foreign manufacturer and $67 to be paid by the AR. Fees are charged for renewal upon expiry of the certificate.

This can be completed by InternationalAssociates on your behalf.

VALIDITY

The registration certificate is valid for five years.

DOCUMENTATION LANGUAGE AND LABELLING

The product registration dossier can be drafted in English.

The labelling (labels and instructions for use) for Medical Devices for professional use can be made available in English, while that for devices for domestic use shall be in Urdu. In all cases, in addition to the identification details of the foreign manufacturer, it must also include those of the local Authorised Representative/importer.

USEFUL INFORMATION

It is necessary to make a proper preliminary assessment for the grouping of devices to be registered: Precise criteria involving the intended use and categorisation as a single device, family, set or other are laid down by DRAP.

REGULATORY AUTHORITY

Drug Regulatory Authority of Pakistan (DRAP) https://www.dra.gov.pk

CLASSIFICATION

Medical Devices are split into categories.

• Class A (low risk),
• Class B (low-moderate risk),
• Class C (moderate-high risk),
• Class D (high risk)

QUALITY SYSTEM

The Quality Management System must be in accordance with ISO 13485:2016