Medical devices sold in Pakistan are regulated by the Drug Regulatory Authority of Pakistan (DRAP) under the Medical Devices Rules, 2017. Whether you manufacture surgical instruments in Sialkot, import diagnostic equipment for hospitals, or distribute disposables to clinics, you need two kinds of approval: a licence for your business and a registration or enlistment for each device. This guide explains how DRAP classifies devices, which licence you need, what goes into a device dossier, and where applications most often stall.
Quick answer: To sell a medical device in Pakistan, first obtain a DRAP establishment licence to manufacture or import medical devices, then classify each device into risk Class A, B, C or D and apply for its enlistment (Class A) or registration (Classes B to D) through DRAP’s online medical devices system. The establishment licence is valid for five years. Imported devices typically need proof of approval and free sale in the country of origin and a recognised quality management certificate such as ISO 13485.
Is my product a medical device under DRAP rules?
A medical device is an instrument, apparatus, implant, in-vitro reagent, software or similar article intended for a medical purpose such as diagnosis, prevention, monitoring or treatment, and which does not achieve its main effect through pharmacological, immunological or metabolic action. If the main action is pharmacological, the product is a drug and follows a different pathway.
Borderline products, such as medicated cosmetics, disinfectants, nutraceuticals and wellness gadgets, are where most classification mistakes happen. Our DRAP classification guide explains how to work out which regulator owns your product before you spend money on the wrong application.
How does DRAP classify medical devices?
Devices are grouped into four risk classes. The class decides how much evidence DRAP expects and how closely the application is reviewed.
| Class | Risk level | Examples |
|---|---|---|
| Class A | Low | Tongue depressors, examination gloves, disposable masks |
| Class B | Low to moderate | Hypodermic needles, suction equipment |
| Class C | Moderate to high | Lung ventilators, bone fixation plates |
| Class D | High | Heart valves, implantable defibrillators |
Classification follows rules based on how long the device stays in the body, whether it is invasive or active, and which organs it affects. Accessories are classified in their own right. If your device could fall into two classes, the higher one applies.
Which DRAP licence does my business need?
According to DRAP’s medical devices establishment licence page, there are two types of establishment licence: one to manufacture medical devices, components or accessories, and one to import them. Applications are handled by DRAP’s Division of Medical Devices and Medicated Cosmetics through its online licensing system, and the licence is valid for five years unless suspended or revoked.
- Manufacturers need a licence for the manufacturing premises, with a quality management system, controlled production areas and testing arrangements that DRAP inspects.
- Importers need a licence covering their storage premises and arrangements for handling, traceability and complaints. The importer acts as the foreign manufacturer’s responsible party in Pakistan.
The establishment licence comes first. Device registrations are filed in the name of a licensed establishment, so an unlicensed company cannot register products.
What is the difference between enlistment and registration?
Low-risk Class A devices are enlisted, which is a lighter process based on a declaration and supporting documents. Class B, C and D devices are registered, which involves a fuller technical review of safety and performance evidence. Higher classes take longer and attract more questions, so plan launch dates around the class, not around the shipping schedule.
What goes into a medical device registration dossier?
DRAP publishes checklists for each application type, and these are updated, so always work from the current checklist. A typical dossier for an imported device includes:
- Device description, intended use, variants and the classification rationale
- Letter of authorisation from the legal manufacturer to the Pakistani importer
- Free sale certificate or approval evidence from the country of origin or a reference regulator
- Quality management system certificate, usually ISO 13485, for the manufacturing site
- Conformity evidence with recognised standards, test reports, and for higher classes, clinical evidence
- Labels, instructions for use and packaging artwork
- Sterilisation validation and shelf-life data for sterile devices
Local manufacturers submit their own technical file and quality system evidence instead of foreign approvals. If your factory needs a quality system first, our ISO certification service covers ISO 13485 implementation, and our QC laboratory reference explains the testing setup regulators expect.
How does the DRAP application process work, step by step?
- Set up the business: company registration, NTN and, for importers, sales tax registration and trader registration. See our import export registration guide.
- Prepare the premises to the standard required for manufacturing or storage.
- Apply for the establishment licence on DRAP’s online system, pay the fee and host the inspection.
- Classify each device and assemble its dossier.
- Submit enlistment or registration applications and answer DRAP’s queries.
- Import or release devices only after the device is enlisted or registered, and keep post-market records of complaints, recalls and adverse events.
Why do DRAP medical device applications get delayed?
- Wrong classification, which means the dossier lacks the evidence the true class requires
- Expired or unlegalised free sale certificates and authorisation letters
- Labels that do not match the device, its variants or the manufacturer named in the dossier
- Premises that do not meet storage or manufacturing requirements at inspection
- Shipping stock before registration, which leaves goods held at port
Frequently asked questions
Who regulates medical devices in Pakistan?
The Drug Regulatory Authority of Pakistan (DRAP), through its Division of Medical Devices and Medicated Cosmetics, under the Medical Devices Rules, 2017.
Do I need a DRAP licence to import medical devices?
Yes. An importer needs a DRAP establishment licence to import medical devices, and each device must also be enlisted or registered before it is imported for sale.
How long is a DRAP establishment licence valid?
DRAP states that the establishment licence to manufacture or import medical devices is valid for five years unless it is suspended or revoked earlier.
What are the medical device classes in Pakistan?
Devices are classified by risk into Class A (low), Class B (low to moderate), Class C (moderate to high) and Class D (high). Class A devices are enlisted; Classes B to D are registered.
Is ISO 13485 required for DRAP registration?
DRAP expects evidence of a quality management system for the manufacturing site, and ISO 13485 certification is the standard way manufacturers show it. Check the current dossier checklist for your device class.
How CEC can help with DRAP medical device approvals
Connect Engineers & Consultants supports medical device manufacturers and importers from classification to approval: establishment licence applications, premises readiness, dossier preparation, ISO 13485 implementation and query handling with DRAP. See our healthcare licensing service.
Bringing a device to the Pakistani market? Share the device and its intended use, and we will confirm its class and the approvals it needs.
DRAP’s rules, classification guidance, forms and fees are revised from time to time. Confirm current requirements with DRAP before you apply. This guide is general information, not legal or regulatory advice.
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