What is Medisure Compliance?

Medisure Compliance is a consultancy firm specializing in medical device registration in Pakistan. We assist manufacturers, importers, and distributors in obtaining regulatory approvals from the Drug Regulatory Authority of Pakistan (DRAP) and ensure full compliance with all applicable laws.

What services does Medisure Compliance offer?

We offer consultancy services for medical device businesses, including DRAP compliance, import licensing, regulatory documentation support, post-market compliance, and consultation for local & international manufacturers.

Why is medical device registration necessary?

Medical device registration ensures that all products meet safety, quality, and performance standards as required by DRAP. Without proper registration, medical devices cannot be legally sold in Pakistan.

Who needs medical device registration in Pakistan?

Any manufacturer, importer, or distributor dealing with medical devices must register their products with DRAP. This applies to both local and international companies planning to enter the Pakistani market.

How long does the registration process take?

The registration process can vary depending on the complexity of the medical device and DRAP’s review timeline. On average, the process takes anywhere from 3 to 12 months.

What are the requirements for medical device registration?

The requirements vary by device classification but generally include a technical dossier, quality certifications (ISO, CE, FDA), local representation for foreign manufacturers, and performance & safety documentation. Our team will assist you through every step of the process.

Does Medisure Compliance offer post-registration support?

Yes! We provide ongoing regulatory support to ensure your products remain compliant with DRAP requirements, including license renewals and post-market surveillance.

Can Medisure Compliance help international manufacturers register their products in Pakistan?

Yes! We specialize in assisting international medical device companies in registering their products with DRAP and complying with local regulations. Our team helps with documentation, local representation, and regulatory approvals.

Contact Us

For inquiries about medical device registration, please reach out. We're here to assist you.