Navigating the Regulatory Landscape for Medical Devices

With a population exceeding 240 million and rapidly increasing healthcare demands, Pakistan presents a significant opportunity for medical device manufacturers. The country's healthcare sector, especially the private segment, is expanding, with numerous well-equipped hospitals and clinics in urban areas. This growth is driving the need for modern medical devices and diagnostic facilities.

Device Classification and Regulatory Pathways

Complying with DRAP Regulations

Regulatory Authority

The Drug Regulatory Authority of Pakistan (DRAP) is responsible for the oversight of medical devices and in vitro diagnostic (IVD) products. DRAP's regulatory framework encompasses conformity assessments, quality management systems, classification guidelines, and registration processes, ensuring that medical devices meet the necessary safety and quality standards before entering the Pakistani market.

Classification

Medical devices and IVD products are classified based on their intended use and risk level. This classification is crucial for determining the regulatory pathway and the level of scrutiny a product will undergo during the DRAP registration process.

Key Requirements

For market access in Pakistan, foreign manufacturers must:

  • Appoint an Authorized Representative to navigate the registration process with DRAP.
  • Compile a comprehensive technical dossier that meets DRAP's requirements for quality and safety.
  • Ensure adherence to post-market follow-up requirements to maintain regulatory compliance.
How We Can Help

Tailored Support for Market Entry

Our services aim to streamline your entry into the Pakistani market:

  • Assistance with product classification and determination of the regulatory pathway.

  • Preparation and compilation of the technical dossier required for DRAP registration.

  • Acting as your Authorized Representative, managing the submission to DRAP and overseeing post-market compliance.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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