DRAP Pakistan Medical Device Registration
With a population exceeding 240 million and rapidly increasing healthcare demands, Pakistan presents a significant opportunity for medical device manufacturers seeking DRAP registration. 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.
Complying with DRAP Regulations
Regulatory Authority
The Drug Regulatory Authority of Pakistan (DRAP) is the agency that regulates medical devices sold in Pakistan. Pure Global can assist with Pakistan medical device registration and local representation, ensuring DRAP approval to sell in 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.
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.
Frequently
Asked Questions
What is the regulatory authority for medical device registration in Pakistan?
The Drug Regulatory Authority of Pakistan (DRAP) is the regulatory authority responsible for the registration and approval of medical devices and in vitro diagnostic (IVD) products in Pakistan. DRAP oversees compliance and regulatory requirements for market entry.
How are medical devices classified in Pakistan?
Medical devices and IVD products in Pakistan are classified based on their intended use and risk level. This classification is essential for determining the appropriate regulatory pathway and the level of scrutiny each product will undergo during the DRAP Pakistan registration process.
What are the key requirements for foreign manufacturers to market medical devices in Pakistan?
Foreign manufacturers must appoint an Authorized Representative to manage the registration process with DRAP. They also need to compile a comprehensive technical dossier that meets DRAP's quality and safety requirements. Additionally, manufacturers must adhere to post-market follow-up requirements to ensure continued regulatory compliance under Pakistan medical device regulations.
What is the role of the Authorized Representative in Pakistan's medical device registration process?
The Authorized Representative acts as the liaison between the foreign manufacturer and DRAP. They are responsible for navigating the Pakistan medical device registration process, ensuring that all regulatory requirements are met, and handling post-market follow-up activities to maintain compliance.
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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.