How to Obtain DRAP Import License and Product Registration for Surgical Disposable Business in Pakistan

Importing allows access to international standards, better pricing, and variety, meeting the growing demand in hospitals and clinics.

This guide covers the import registration process regulated by the Drug Regulatory Authority of Pakistan (DRAP). to legally import and sell surgical disposables (classified as medical devices under the Medical Devices Rules 2017), you must first secure an Establishment License to import (often called DRAP import license), followed by product registration or enlistment.

Note: This builds on wholesale setup with DSL (via Form 11). Many low-risk surgical disposables (Class A) follow simplified enlistment, while higher-risk items require full registration. The process uses the modern MDMC Online System for faster approvals.

Why Import Surgical Disposables in Pakistan?

Pakistan's healthcare sector is expanding rapidly, with increasing private hospitals and emphasis on infection control. Imported surgical disposables often meet international certifications (e.g., CE, ISO), building trust and allowing higher margins.

Importing directly cuts intermediaries, but requires strict compliance to avoid customs delays or penalties.

Legal Framework for Importing Medical Devices

The DRAP Act 2012, Medical Devices Rules 2017, and related guidelines govern imports. DRAP's Medical Devices Division oversees this. Key requirements:

• Valid Establishment License to import (Form-2 application).
• Product enlistment (Class A) or registration (Class B/C/D).
• Compliance with Good Distribution Practices for Medical Devices (GDPMD).

Surgical disposables like gloves and syringes are typically Class A (low risk), simplifying the process.

Step 1: Business Preparation Before Applying for Import License

Ensure your business is ready:

• Register as a private limited company (SECP) for credibility.
• Secure NTN, sales tax registration (FBR).
• Have suitable premises: Warehouse with proper storage (temperature-controlled, pest-free, adequate space).
• Appoint qualified staff (e.g., technical personnel familiar with medical devices).

Without these, your DRAP import license application will be rejected.

Step 2: Applying for Establishment License to Import (DRAP Import License)

This is the first mandatory step. The license is valid for 5 years and issued by the Medical Device Board (MDB).

Process:

1. Register on the MDMC Online System at e.dra.gov.pk.
2. Submit online application for Establishment License to Import.
3. Download and fill Form-2 (Application for Grant or Renewal of an Establishment License to Import Medical Devices).
4. Prepare and upload required documents (see checklist below).
5. Submit hard copy of the application to Medical Devices Division, DRAP.
6. Pay fees (vary by class, e.g., around $21–$222 USD equivalent for different classes).
7. Allow premises inspection by DRAP panel for GDPMD compliance.
8. Approval by MDB and issuance of license.

Step 3: Required Documents for DRAP Import License Application

Key documents include:

• CNIC and photos of applicant/owners.
• Business registration certificates (SECP/NTN).
• Premises layout plan and ownership/lease proof.
• List of intended surgical disposables to import (categories/names).
• Qualified person's details (technical staff).
• Declaration and undertaking on stamp paper (as per Form-2).
• Fee payment proof.

Step 4: Product Registration/Enlistment After Import License

With the Establishment License, proceed to register/enlist products.

• Class A (most surgical disposables): Simplified enlistment via Form 6-A.
• Higher classes: Full registration via Form 7-A.

Submit:

• Manufacturer authorization.
• Free Sale Certificate, Declaration of Conformity, CE/ISO certificates.
• Technical documentation.
• Labeling in English (and Urdu where required).

Step 5: Importing Process and Customs Clearance

Once licensed and products registered:

• Notify arrival via Form-11 (Intimation of Arrival).
• Provide Bill of Lading, Invoice, Packing List.
• Obtain clearance certificate from DRAP field office.
• Clear customs with DRAP approvals.

Step 6: Good Distribution Practices and Storage

Comply with GDPMD (Good Distribution Practices for Medical Devices):

• Temperature/humidity control.
• FIFO inventory.
• Traceability records.

This is inspected during licensing and ongoing.

Step 7: Marketing and Scaling Your Import Business

Use imports for premium branding. Target hospitals, offer samples, build an online catalog.

Step 8: Challenges and Best Practices

• Delays in inspection: Prepare premises meticulously.
• Changes in rules: Monitor DRAP notifications.
• Counterfeits: Source from verified manufacturers.

Quick Takeaways

• Secure DRAP import license first via Form-2 and online system.
• Obtain product enlistment/registration next for each surgical disposable.
• Ensure premises comply with GDPMD for inspection success.
• Use digital portal for faster processing.
• Import only after full compliance to avoid customs issues.
• Focus on Class A disposables for simpler enlistment.

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