Most medical equipment import problems happen before the shipment even leaves the origin country. Wrong classification. Missing DRAP license. No PSW access. Wrong HS code. These are not customs problems — they are preparation problems. This guide covers every step, every authority, every document. In plain language. So you know exactly what you’re walking into.
Who Controls Medical Equipment Imports in Pakistan?
Not one authority. Four.
DRAP — Drug Regulatory Authority of Pakistan
Regulates what can be imported and sold. No DRAP registration = no legal sale in Pakistan.
FBR / Pakistan Customs
Collects duties. Controls clearance. Operates through WeBOC and PSW.
PSW — Pakistan Single Window
The digital gateway for all import declarations. Every importer needs an active PSW User ID linked to their NTN.
PNRA — Pakistan Nuclear Regulatory Authority
Required additionally for any radioactive medical equipment — PET scanners, radiation therapy machines, nuclear medicine devices.
Step 1: Get Your DRAP Establishment License
Before you import a single device, you must obtain an Establishment License from DRAP’s Medical Devices Division.
Submit an online application through the MDMC Online System, followed by a physical hardcopy submission to DRAP on Form-2. Once the complete application is received, DRAP may conduct a premises inspection.
Establishment Licenses are valid for 5 years, unless revoked or suspended earlier.
What you need for the Establishment License:
- Company registration documents
- NTN certificate
- Storage premises details (DRAP may inspect)
- Authorized person details
Step 2: Understand Your Device Classification
Pakistan classifies medical equipment into four categories. Your classification determines your entire regulatory pathway.
| Class | Risk Level | Examples |
| Class A | Low risk | Bandages, tongue depressors, consumables |
| Class B | Low-to-moderate risk | Surgical instruments, diagnostic equipment |
| Class C | Moderate-to-high risk | Implantable devices, life-support equipment |
| Class D | High risk | Active implantable devices, highest scrutiny |
Getting your classification wrong delays registration by months. A Class B device and a Class C device require completely different documentation packages. Get it right before the shipment moves.
Step 3: Register Your Device with DRAP
Every medical device intended for import and sale must be registered. Required documents vary by class.
| Document | Class A | Class B | Class C/D |
| ISO 13485 Certificate | ✓ | ✓ | ✓ |
| Letter of Authorization from Manufacturer | ✓ | ✓ | ✓ |
| Free Sale Certificate | ✓ | ✓ | ✓ |
| Declaration of Conformity | ✓ | ✓ | ✓ |
| CE Marking / FDA Approval | – | ✓ | ✓ |
| Clinical Evaluation Data | – | ✓ (some) | ✓ |
| Production/QA Certificate | ✓ | ✓ | ✓ |
Foreign manufacturers must appoint a registered agent in Pakistan who is responsible for communicating with DRAP and submitting the registration application.
Registration typically takes 3 to 6 months for new devices.
In July 2025, DRAP launched a new e-service portal for medical device licensing and registration. This has begun reducing the backlog of pending applications and limits the need for direct human interaction in the process.
Step 4: Get Your NTN and PSW User ID
You cannot file a Goods Declaration without these two things active and linked.
NTN (National Tax Number)
Mandatory for any import business in Pakistan. Without it, you cannot open a commercial bank account or clear goods through customs at any port or dry port.
PSW User ID
Pakistan Single Window is the integrated digital platform that allows parties involved in trade to lodge standardized information and documents through a single entry point to fulfill all import, export, and transit-related regulatory requirements.
CRITICAL WARNING: Your PSW User ID must be registered against an active, current employee with valid CNIC and NADRA biometric verification. If the registered person leaves your organization, your PSW access is locked — and so is your cargo. We learned this firsthand with Mayo Hospital Lahore. A former employee’s credentials locked a critical equipment shipment at Allama Iqbal Airport. It took FBR Form 181 update, NADRA biometric re-verification, and a CEO authorization letter to restore access.
Step 5: Prepare Your Import Documents
Every shipment needs this core set:
- Commercial Invoice (CIF value stated clearly)
- Packing List
- Bill of Lading or Airway Bill
- DRAP Establishment License
- Device Registration Certificate
- Certificate of Origin
- Manufacturer’s Authorization Letter
- Insurance Certificate
Additional documents by device type:
- Radioactive / radiation-emitting equipment → PNRA import approval
- Wireless / telecom-enabled devices (patient monitors, wireless ECG) → PTA Type Approval
Step 6: Understand Your Duties and Taxes
Medical devices are subject to customs duties ranging from 0% to 20% depending on the specific product classification. A standard GST of 17% is applied to most imported medical devices, calculated on the sum of CIF value plus customs duty.
How duties are calculated (CIF method):
| Component | Rate / Basis | Example (PKR) |
| Equipment CIF Value | Cost + Insurance + Freight to Pakistan | 1,000,000 |
| Customs Duty | 0%–20% depending on HS code | 50,000 (at 5%) |
| GST | 17% on (CIF + Customs Duty) | 178,500 |
| Total Landed Cost | — | 1,228,500 |
Certain medical devices may qualify for duty exemption — for example, donations of medical equipment to charitable organizations or public hospitals. Always verify against the applicable SRO before filing.
Step 7: File Your Goods Declaration (GD)
All import declarations are filed through WeBOC by your licensed customs broker. It enables paperless, real-time processing at all major seaports, airports, and dry ports across Pakistan.
Customs assigns your shipment to one of three channels after GD filing:
| Channel | What Happens | Impact |
| Green Channel | Cleared without inspection | Fastest clearance |
| Yellow Channel | Document examination only | Minor delay |
| Red Channel | Full physical examination | Significant delays + storage charges |
The best way to avoid Red Channel: correct HS code, accurate CIF invoice value, complete documentation, and a broker who knows the medical equipment category.
The Most Common Reasons Medical Equipment Gets Stuck
- DRAP Establishment License expired or not obtained before shipment
- Device not registered with DRAP before arrival
- PSW credentials inactive or linked to a departed employee
- Wrong HS code triggering FBR valuation dispute
- Missing PTA approval for wireless or connected devices
- Missing PNRA approval for radiation-emitting equipment
- Invoice value below FBR’s valuation ruling — triggering reassessment
- Incomplete or missing manufacturer authorization letter
Every single one of these is avoidable with proper preparation. Every single one has delayed a shipment we have seen in the field.
Summary: The Complete Import Checklist
| Step | What | Authority |
| 1 | DRAP Establishment License | DRAP |
| 2 | Device Classification (A/B/C/D) | DRAP |
| 3 | Device Registration | DRAP |
| 4 | NTN + PSW User ID Active | FBR / PSW |
| 5 | Import Documents Package | Multiple |
| 6 | Duty Calculation (CIF + CD + GST) | FBR / WeBOC |
| 7 | Goods Declaration Filing | Pakistan Customs |
| + | PNRA Approval (if radioactive) | PNRA |
| + | PTA Type Approval (if wireless/telecom) | PTA |
Need Help? Talk to Glavik.
Glavik is Pakistan’s only dedicated healthcare logistics company. We handle DRAP compliance, PSW credential recovery, customs clearance, cold chain, dangerous goods, and turnkey hospital equipment setups — end to end.
We don’t hand you a GD number and walk away. We stay until the equipment is in the hospital.
don’t hand you a GD number and walk away. We stay until the equipment is in the hospital.
📩 hq@glavik.com
🌐 www.glavik.com
📞 +92 321 4591020
📍 Landmark Plaza, Jail Road, Lahore, Pakistan