Medical device regulatory feasibility
Before you sign a distribution agreement or commit to a registration, find out whether the device can be registered in Pakistan, by which route and at what effort. We answer those questions in a written assessment.
This is a regulatory affairs and market research consultancy service. It is offered separately from the clinical research services InnovexHealth CRO Pvt Ltd provides under its DRAP licence.
Classification
We classify each device under the DRAP Medical Devices Rules 2017, from Class A to Class D, and explain what each class requires.
Registration pathway
The route depends on where the device is made and which approvals it already holds. For devices made outside DRAP’s reference countries, existing CE certification usually decides the pathway, and whether that certificate was issued under the former Medical Devices Directive or the current EU Medical Device Regulation matters.
Dossier gap analysis
We compare the manufacturer’s technical documentation with what DRAP expects and list what is missing, item by item.
Pre-submission consultation
Where the pathway is uncertain, we seek DRAP’s view before you invest in a full dossier.
A written report you can act on
A written report covering the classification of every product in scope, the recommended registration pathway, a gap list ranked by effort, an estimate of time to registration, and the main risks. For a product catalogue, we report at the level of each individual product code.
Who this is for
Importers and distributors evaluating a new principal. Overseas manufacturers considering Pakistan. Local manufacturers preparing a first registration.