How to Get Medical Devices Approved for Sale in Pakistan

Selling or importing medical devices in Pakistan needs official approval from DRAP (Drug Regulatory Authority of Pakistan). Whether you are indeed a local manufacturer or perhaps an international supplier, if you get for yourself your product legally approved, then a clear but sometimes technical process is surely involved. Here are simplified steps below that explain how you can register medical devices with DRAP. You can then start to sell those devices legally within the Pakistani market.

What Is a Medical Device According to DRAP?

DRAP defines a medical device as being any instrument or machine or software or implant or material that is used in the diagnosis or treatment or monitoring or prevention of diseases or injuries in humans.

. This includes items like:

• Blood pressure monitors
  
• Thermometers
  
• Syringes
  
• X-ray machines
  
• Implants and surgical instruments
  
• Diagnostic software
  

If your product is used on the human body and not a drug or medicine, it’s likely considered a medical device.

Step-by-Step Guide to DRAP Registration

1. Get Your Company Enlisted:
   First, your company must be listed with DRAP. This includes getting a Site License (for manufacturers) or Establishment License (for importers/wholesalers).
   
2. Classify Your Device:
   DRAP uses a classification system (Class A, B, C, D) based on the risk level. For example:
   
   • Class A: Low risk (e.g., tongue depressors)
     
   • Class D: High risk (e.g., heart valves)
     
3. Prepare Technical Documents:
   Submit documents that prove your product is safe and effective. This usually includes:
   
   • CE Certification (European Conformity)
     
   • ISO 13485 (quality management for medical devices)
     
   • Product descriptions, packaging, user manuals
     
   • Test reports, performance data
     
4. Apply Online through DRAP Portal:
   Upload all required forms and documents at DRAP’s official website.
   
5. Pay the Application Fee:
   Payment is made through challan in designated banks. Fee varies depending on the product class.
   
6. Wait for Evaluation:
   DRAP evaluates your documents and may ask for clarifications. The Registration Board meets every few months to approve or reject applications.
   
7. Get Certificate of Registration (Form-6):
   Once approved, you’ll receive a Form-6 certificate, which allows you to sell the product in Pakistan legally.
   

Types of Licenses You May Need

License Type	Who Needs It
Manufacturer License (Form-3)	Local companies making devices
Import License (Form-4)	International brands/distributors
Wholesale/Distributors License (Form-5)	Local suppliers or traders

Technical Documents Required

Here’s what you typically need to submit to DRAP:

• CE Certificate
  
• ISO 13485 Certificate
  
• Free Sale Certificate from origin country
  
• Technical file
  
• Clinical evaluation reports (for high-risk devices)
  
• Labeling and packaging info
  
• Instructions for use (IFU)
  

Timeframe and Cost Estimates

• Initial Company Licensing: 2–4 months
  
• Device Registration: 6–12 months depending on class and backlog
  
• Cost:
  
  • Company license fee: ~PKR 50,000+
    
  • Device registration fee: From ~PKR 25,000 to over 100,000 per device (based on class and type)
    

Note: Third-party consultant costs, translation, and document attestation may add to total expenses.

Common Reasons for Rejection

• Missing CE or ISO certifications
  
• Poor-quality documentation
  
• Incomplete applications
  
• Device not properly classified
  
• Lack of performance test data
  
• Country of origin not WHO-approved
  

Imported vs. Local Devices – What’s Different?

Criteria	Local Devices	Imported Devices
Manufacturing License	Required	Not applicable
Import Permission	Not required	Mandatory import registration
Technical Docs	Required (but simpler if made locally)	CE/ISO must be from foreign manufacturer
Delays	Sometimes faster	May take longer due to extra checks

What Are SROs and the Registration Board?

• SROs (Statutory Regulatory Orders): DRAP sometimes issues special notices that affect registration timelines, fee structures, or category definitions. Always stay updated on these.
  
• Registration Board: A panel of experts that reviews and approves (or rejects) medical device applications. They meet regularly, but slots are limited—so timely and complete submission matters.
  

Why Go Through DRAP?

 Legal protection
Gain market trust
  Avoid product confiscation
  Sell to hospitals, pharmacies, and clinics
  Access public tenders

Also read this: What is a Digital Nomad Visa and Which Countries Offer it to Pakistanis?