Pakistan DRAP Medical Device Registration Guide: Classification, Import Licensing, and Local Agent Requirements

Why Pakistan Is a Growing Medical Device Market

Pakistan regulates medical devices through the Drug Regulatory Authority of Pakistan (DRAP), under the Medical Devices Rules, 2017 (framed under the DRAP Act, 2012). The Medical Devices and Medical Cosmetics Division (MD&MC) of DRAP oversees the registration, licensing, and post-market surveillance of all medical devices and in vitro diagnostic (IVD) products in the country.

With a population exceeding 230 million, Pakistan represents one of the largest underserved medical device markets in South Asia. The country's healthcare system is undergoing rapid modernization, with expanding public hospital infrastructure under provincial health departments and a growing private sector. The government's Digital Health Transformation initiative, including the launch of DRAP's e-service portal for medical device licensing and registration in July 2025, signals a commitment to regulatory modernization.

DRAP's regulatory framework is aligned with the Global Harmonization Task Force (GHTF) and the Asian Harmonization Working Party (AHWP) guidance documents, covering general medical devices, IVDs, and combination products. The framework establishes a complete lifecycle approach: establishment licensing, device registration, good distribution practices, and post-market surveillance.

Regulatory Framework Overview

Governing Legislation

Regulatory Bodies

• Drug Regulatory Authority of Pakistan (DRAP): National regulatory authority headquartered at Prime Minister's National Health Complex, Park Road, Chak Shahzad, Islamabad
• Medical Device Board (MDB): Constituted under the Medical Devices Rules, responsible for establishment licensing, registration of conformity assessment bodies (CABs), device registration, post-market surveillance, and ancillary functions
• Provincial Health Departments: Responsible for regulating sales and distribution at the provincial level

Key Principles

• Mandatory registration: All medical devices must be registered with DRAP before they can be imported, manufactured, or sold in Pakistan
• Establishment licensing first: Importers and manufacturers must obtain an Establishment License before submitting device registration applications
• Four-tier classification: Devices are classified as Class A, B, C, or D based on risk, aligned with GHTF principles
• Authorized representative required: Foreign manufacturers must appoint a local entity (Market Authorization Holder) in Pakistan
• ISO 13485 requirement: Manufacturers must demonstrate compliance with ISO 13485 or equivalent quality management system

Medical Device Classification in Pakistan

Classification System

Pakistan uses a four-tier classification system aligned with GHTF/AHWP guidelines:

Classification Rules

Classification follows rules established in the Medical Devices Rules, 2017, which cover:

• Non-invasive devices (Rules for devices that do not penetrate the body)
• Invasive devices (Rules based on degree and duration of invasion)
• Active devices (Rules for devices powered by energy sources)
• Special rules (Rules for devices incorporating medicines, human tissues, or nanomaterials)

The actual classification depends on the manufacturer's stated intended use and the specific claims made for the device.

The Registration Process

Step 1: Obtain an Establishment License

Before any device registration can proceed, the importer or manufacturer must obtain an Establishment License from the Medical Devices Division of DRAP. This is a mandatory prerequisite.

Requirements for Establishment License:

• Application submitted online through the MDMC Online System
• Proof of business registration in Pakistan
• Qualified person responsible for regulatory compliance
• Facility documentation (warehouse, quality control, distribution)
• Good Distribution Practice for Medical Devices (GDPMD) compliance
• Application fee payment

The Establishment License is valid for five years and must be renewed before expiry.

Step 2: Appoint an Authorized Representative (Market Authorization Holder)

Foreign manufacturers must appoint a local entity in Pakistan to act as their Authorized Representative, also referred to as the Market Authorization Holder. This entity:

• Must be legally established in Pakistan
• Holds an active DRAP Establishment License
• Is responsible for communicating with DRAP and submitting registration applications
• Bears regulatory responsibility for the device in Pakistan
• Must maintain records and support post-market surveillance activities

The Authorized Representative cannot transfer the registration certificate to another establishment without prior written approval from the MDB. If a transfer is needed, the current holder must first cancel the certificate, surrender the original within 14 days, and the new entity can then apply for a fresh registration.

Step 3: Prepare the Registration Dossier

The registration dossier must be submitted in the format specified by DRAP. Key components include:

Administrative Information:

• Application form (completed online)
• Authorized Representative authorization letter from the manufacturer
• Establishment License copy of the local representative
• Fee payment proof

Product Technical Documentation:

• Device description and intended use
• Classification rationale with rule justification
• Medical and technical specifications
• Essential Principles conformity checklist
• Risk analysis and management documentation
• Clinical evaluation report or clinical evidence summary
• Design verification and validation data

Quality Management System:

• ISO 13485 certificate for the manufacturer
• Good Manufacturing Practice (GMP) compliance evidence
• FDA Establishment Inspection Report or equivalent (if available)

Labeling and Packaging:

• Labels in English and Urdu (domestic use products must include Urdu)
• Instructions for Use (IFU) in English
• Packaging samples or artwork

Reference Country Approvals (if available):

• Copies of marketing authorization from recognized reference countries listed under Rule 67 of the Medical Devices Rules, 2017 (includes USA, Japan, Australia, Canada, and EU member states)
• Free Sale Certificate duly attested by the Embassy of Pakistan in the country of origin

Product Identification:

• HS code for the medical device (if applicable)
• GMDN code for the medical device (if applicable)
• Complete device description with intended use
• Grouping justification (when registering multiple devices under one application)

Step 4: Submit the Application

As of July 21, 2025, DRAP has launched an e-service portal for medical device licensing and registration. Applications must be submitted online through this portal. Previously, applications were submitted as hard copies with a USB/CD containing the electronic dossier to DRAP's Medical Devices Division.

The import NOC (No Objection Certificate) for medical devices has also transitioned to the Pakistan Single Window (PSW) system, effective March 4, 2026.

Step 5: DRAP Review and Evaluation

The review process involves:

1. Formal/Administrative Review: DRAP verifies completeness of the submission, correct format, and fee payment
2. Technical Evaluation: The Medical Device Board evaluates the technical documentation, classification, clinical evidence, and conformity with Essential Principles
3. Query Resolution: DRAP may request additional information or clarification during the review
4. Site Inspection (if required): Manufacturing site inspections are sometimes required, particularly for devices not previously approved by recognized reference countries. On-site inspection may be exempted if the legal manufacturer is based in EU countries or the USA

Step 6: Registration Approval

Upon successful completion of the review process, DRAP grants registration approval and issues a Registration License. The license:

• Is valid for five years
• Is specific to the registered establishment (cannot be transferred without MDB approval)
• Must be renewed before expiry

Registration Fees

DRAP revised its fee structure through S.R.O. 1399(I)/2025, effective August 1, 2025. Approximate registration fees for new applications:

Fees are denominated in Pakistani Rupees (PKR) and are subject to exchange rate fluctuations. Contact DRAP directly or check the current fee schedule on the DRAP website for exact amounts.

Labeling Requirements

Language

• Labels for products intended for domestic consumer use must be in Urdu and English
• Labels for professional/healthcare facility use may be in English
• The product registration dossier may be drafted in English

Required Label Information

Per Chapter VI of the Medical Devices Rules, labels must include:

• Device name and model
• Manufacturer name and address
• Authorized Representative name and address in Pakistan
• Country of manufacture
• Lot number or serial number
• Date of manufacture and expiry date (where applicable)
• Storage conditions
• Instructions for use or reference to IFU
• Regulatory classification
• DRAP registration number

Adverse Event Reporting and Post-Market Surveillance

Adverse Event Reporting

DRAP has published Adverse Event Reporting Guidelines for patients, caretakers, and consumers. The Authorized Representative must maintain a system for:

• Receiving and investigating complaints
• Reporting serious adverse events to DRAP
• Implementing field corrective actions
• Managing product recalls

Post-Market Obligations

Once the registration license is obtained, the establishment must:

• Continuously comply with relevant regulations and standards
• Accept ongoing supervision by DRAP
• Monitor registration certificate validity and apply for timely renewal
• Report changes in product design, manufacturing site, or quality system to DRAP
• Report sales data as required
• Cooperate with market surveillance inspections

Advertising and Promotion

Advertising of medical devices in Pakistan is regulated under the Regulation of Advertisement of Therapeutic Goods. All promotional materials must comply with DRAP requirements and must not make claims beyond the registered intended use.

Special Considerations

Import Process

Medical device imports require:

• A valid DRAP Registration License for the device
• An Import NOC (No Objection Certificate), now processed through the Pakistan Single Window (PSW) system as of March 4, 2026
• A valid import permit (valid for five years)
• Compliance with customs documentation requirements

Local Testing

Local testing is not generally required for device registration. However, the Medical Device Board may occasionally require a sample of the registered device to be sent for analysis or testing.

Exemption from On-Site Audit

Manufacturing site inspections by DRAP are sometimes required, but on-site inspection may be exempted if the legal manufacturer is based in countries with recognized regulatory systems, including:

• United States
• European Union member states
• Japan
• Australia
• Canada
• Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom

PIC/S Alignment

Pakistan is actively pursuing PIC/S (Pharmaceutical Inspection Co-operation Scheme) membership as part of its regulatory transformation. This alignment with international standards is expected to further strengthen the country's regulatory framework and increase confidence in DRAP-registered devices.

Practical Timeline and Cost Estimates

Typical Timeline

Devices with reference country approvals from recognized authorities (FDA, CE, etc.) may qualify for faster review. Some sources report timelines as short as 3–6 months for straightforward applications with complete documentation.

Cost Estimates

Comparison with Other South Asian Markets

Key Takeaways

1. Establishment License comes first: The local representative must hold a valid DRAP Establishment License before any device registration can proceed
2. New e-service portal simplifies submissions: Since July 2025, all applications are submitted online — no more physical dossier delivery
3. Import NOC now on Pakistan Single Window: As of March 4, 2026, import NOCs are processed through the PSW system
4. Reference country approvals help: Devices cleared by FDA, CE, TGA, or other recognized authorities may receive expedited review and are often exempt from on-site audits
5. Low government fees, but plan for total cost: While DRAP registration fees are modest (USD 25–250), authorized representative services, consulting, and dossier preparation represent the bulk of market entry costs
6. Urdu labeling required: Ensure labels for consumer-facing products include Urdu translations
7. PIC/S alignment underway: Pakistan's pursuit of PIC/S membership signals increasing regulatory sophistication — early registration positions manufacturers well for the evolving landscape