Pakistan DRAP Registered Medical Devices Teardown & 2025 Ramp
A quantitative analysis of the 12,666 medical devices registered under Pakistan's DRAP, detailing the Class A-D splits, local-vs-import manufacturer mix, and the 2025 registration surge.
Pakistan DRAP Registered Medical Devices Teardown: 12,666 Devices, Class A/B/C/D Split, Local-vs-Import Manufacturer Mix, and the 2025 Registration Ramp
Pakistan represents one of the largest and most dynamic healthcare markets in South Asia. With a population exceeding 240 million people, the demand for medical technology is surging. According to market benchmarks from Pure Global, Pakistan’s medical device market is projected to reach approximately $1.02 billion by 2029, growing at a compound annual growth rate (CAGR) of 8.11%. Despite this significant scale, the market remains highly dependent on international suppliers, with approximately 90% of all medical devices imported.
For regulatory affairs, market access, and commercial operations teams targeting Pakistan, navigating the regulatory approval process is the first critical step. The regulatory framework is overseen by the Drug Regulatory Authority of Pakistan (DRAP) under the Ministry of National Health Services, Regulations and Coordination. Specifically, the Medical Devices & Medical Cosmetics Division (MD&MC) is responsible for enforcing the Medical Devices Rules 2017, which governs the classification, enlistment, registration, import, and post-market surveillance of medical devices and in vitro diagnostics (IVDs).
To help medtech executives size the market, identify potential local partners, and understand competitive concentration, this article provides a detailed data teardown of the official DRAP medical device register. Our analysis is based on the DRAP enlisted and registered medical device lists (August 28, 2025 snapshot), comprising 12,666 unique records.
Skip to Your Scenario
To help you quickly navigate this comprehensive guide, select the scenario that best matches your current strategic objective:
- How many medical devices are on DRAP's list and how do they split by Class A/B/C/D? — Market sizing and portfolio risk profiling.
- How do Pakistan's Class A 'Enlisted' and Class B/C/D 'Registered' tracks differ? — Regulatory pathway selection and timeline planning.
- Which manufacturers dominate the DRAP list (the local-vs-import mix)? — Competitor analysis and partner selection.
- How has DRAP registration volume ramped since 2018, and what drove the 2025 spike? — Analyzing regulatory efficiency and system maturity.
- What is the DRAP regulatory regime (Act 2012, Medical Devices Rules 2017) behind this list? — Compliance standards, labeling, and legal boundaries.
- Detailed Step-by-Step Registration Workflow via the DRAP e-Service Portal — Administrative pipeline and milestones.
- Strategic Local-Partner and Local-Manufacturing Selection for Pakistan Market Entry — Commercial channel execution.
How many medical devices are on DRAP's list and how do they split by Class A/B/C/D?
Pakistan’s DRAP follows a risk-based classification system for medical devices, which is closely aligned with international standards established by the Global Harmonization Task Force (GHTF) and the Asian Harmonization Working Party (AHWP). Devices are categorized into four risk classes:
- Class A (Low Risk): Non-invasive devices, simple surgical instruments, and basic consumables.
- Class B (Low-to-Moderate Risk): Minor invasive devices, basic diagnostic equipment, and low-risk IVDs.
- Class C (Moderate-to-High Risk): Complex active devices, therapeutic equipment, and specialized implants.
- Class D (High Risk): Life-support systems, cardiovascular implants, and critical IVD reagents.
Based on our analysis of the 12,666 records in the DRAP dataset, the risk-class distribution is structured as follows:
| Risk Class | Number of Records | Percentage of Register | Key Examples in Register |
|---|---|---|---|
| Class A | 2,243 | 17.7% | Bandages, surgical tapes, tongue depressors, manual wheelchairs |
| Class B | 4,494 | 35.5% | Hypodermic needles, syringes, catheters, contact lenses, dental fillers |
| Class C | 3,279 | 25.9% | Orthopedic implants, ventilators, surgical lasers, infusion pumps |
| Class D | 2,472 | 19.5% | Cardiac stents, pacemakers, heart valves, HIV diagnostic kits |
| Unclassified | 178 | 1.4% | Transition-period listings, legacy registrations |
| Total | 12,666 | 100.0% | Comprehensive DRAP Database |
Key Takeaway: The Dominance of Class B and C Devices
Class B and Class C devices represent the vast majority of the register, accounting for 61.4% of all approved devices (7,773 records combined). This concentration highlights the mature nature of the register for standard clinical consumables and diagnostic equipment. For international manufacturers, this means that the regulatory pathways for moderate-risk devices are highly active and frequently utilized by local importers.
Conversely, the Class A segment represents only 17.7% of the registrations. This does not indicate a small market for low-risk consumables; rather, it reflects a historical regulatory lag where many Class A devices were imported under simplified exemption pathways or local-listing transitions. As DRAP enforces stricter compliance under the matured Rules, we expect Class A enlistments to grow.
The unclassified category (1.4%) consists of 178 records that lack a populated class in the official dataset. These represent legacy entries or transition-period files that have been carried forward in the database. Manufacturers should ensure that any new submissions are explicitly classified under the current rules to avoid administrative delays.
How do Pakistan's Class A 'Enlisted' and Class B/C/D 'Registered' tracks differ?
Pakistan operates a two-track regulatory system that separates simple low-risk devices from more complex technologies. Understanding this structural split is essential for regulatory strategy:
- The Enlistment Track (Class A): Reserved for Class A medical devices and IVDs. This is a simplified notification-style process designed to keep low-risk products flowing into the healthcare system without unnecessary bureaucratic delays.
- The Registration Track (Class B, C, and D): Required for all moderate-to-high risk devices. This is a comprehensive pre-market review process involving the submission of a detailed technical dossier, conformity assessment reports, and clinical evaluation summaries.
Our analysis of the dataset confirms that the database is built from two distinct source files, reflecting this regulatory split:
- Enlisted Class A Track: 2,405 records
- Registered Class B/C/D Track: 10,261 records
Note on Data Discrepancy: While the physical risk-class field contains 2,243 Class A devices, the Enlistment file contains 2,405 records. This difference is due to some Class B products or transition listings being temporarily handled through the enlistment track during the early phase of the Medical Devices Rules implementation. For practical purposes, the registry remains structured around these two distinct files.
Structural Differences in the Regulatory Tracks
The operational requirements for the two tracks differ significantly:
+---------------------------------------------------------------------------------+
| Pakistan DRAP |
+---------------------------------------------------------------------------------+
|
+--------------------+--------------------+
| |
[Class A Enlistment] [Class B/C/D Registration]
- 2,405 Records - 10,261 Records
- Simplified Process - Focus: Quality System
- Focus: Quality System - Focus: Safety & Efficacy
- Rapid Approval - 6-12 Month Timeline
- Documentation Depth: Class A Enlistment relies heavily on the manufacturer's self-declaration of conformity, basic ISO 13485 certification, and free sale certificates from reference markets. Class B/C/D Registration requires a full technical dossier structured in the Common Submission Dossier Template (CSDT) format, detailing design controls, clinical evaluation reports, and risk management files.
- Approval Timelines: Enlistments are typically processed in a matter of weeks, whereas Class B/C/D registrations require formal review by the Medical Devices Board (MDB) and can take anywhere from 6 to 12 months.
- Fee Structure: The government fees for registration are substantially higher than those for enlistment. Importers must pay distinct fees for the initial dossier review, site inspections (when applicable), and import licenses for registered products.
Which manufacturers dominate the DRAP list (the local-vs-import mix)?
Pakistan's medical device register is highly concentrated, with a small number of multinational firms and large local distributors holding a significant portion of the approved records.
Our analysis identifies roughly 500 distinct company groups operating in the register. The raw data lists more than 1,000 name strings, which we consolidated using token-normalization because DRAP records the same firm under multiple address or formatting variations (e.g., "Abbott Laboratories Pakistan" vs. "Abbott Labs").
The top groups by approved record count are:
| Normalised Company Group | Record Count | Market Role | Key Product Focus |
|---|---|---|---|
| Abbott | 792 | Multinational / Import | IVD Reagents, Coronary Stents, Immunoassay Systems |
| Medtronic | 495 | Multinational / Import | Pacemakers, Catheters, Electrosurgical Tools |
| Roche | 406 | Multinational / Import | In Vitro Diagnostics, Diabetes Care, Reagents |
| Global (Distributor) | 314 | Local Representative | Various imported consumables and surgical tools |
| Johnson & Johnson | 307 | Multinational / Import | Surgical Sutures, Orthopedic Implants, Instruments |
| Ferozsons Laboratories | 290 | Pakistani Manufacturer | Local pharmaceuticals, medical consumables, partners |
| Nextek | 184 | Local Importer | Diagnostic systems, imaging, patient monitors |
| Vertex | 174 | Local Importer | Specialized surgical and anesthesia devices |
| United | 159 | Local Importer | Consumables, syringes, infusion lines |
| Hoora | 156 | Local Importer | In vitro diagnostics, rapid test kits |
The Local-vs-Import Manufacturer Mix
This ranking highlights two crucial characteristics of the Pakistani medtech market:
- Multinational Domination of High-Value Segments: The presence of Abbott (792 records), Medtronic (495 records), Roche (406 records), and J&J (307 records) at the top of the list demonstrates the deep market penetration of Western and global medtech giants. These firms dominate the Class C and D categories, particularly in high-value segments like interventional cardiology, orthopedics, and advanced clinical laboratory diagnostics.
- The Crucial Role of Local Representatives: Groups like Global, Nextek, and Vertex represent large local authorized representatives who manage registrations for dozens of smaller foreign manufacturers. They hold the legal registrations, control the local import permits, and manage commercial distribution.
- Domestic Manufacturing Strength: Ferozsons Laboratories is a key domestic highlight. With 290 records, Ferozsons is a prominent Pakistani company that has successfully expanded into local device manufacturing and strategic partnerships (such as manufacturing local diagnostics and joint ventures with international firms). This proves that local manufacturing is viable and actively supported by DRAP’s regulatory framework.
How has DRAP registration volume ramped since 2018, and what drove the 2025 spike?
A longitudinal analysis of the DRAP register reveals how the regulatory system has matured since the introduction of the Medical Devices Rules 2017. By analyzing the date_of_issuance field across the 12,666 records (with 0 blank dates, indicating excellent data integrity), we can map out the annual issuance trends:
- 2018: 101 records
- 2019: 1,137 records
- 2020: 1,079 records
- 2021: 1,289 records
- 2022: 1,691 records
- 2023: 1,957 records
- 2024: 1,798 records
- 2025: 3,614 records
Registration Issuance Trend (2018 - 2025):
4000 | * (3,614)
|
3000 |
|
2000 | * (1,957) * (1,798)
| * (1,691)
1000 | * (1,137) * (1,079) * (1,289)
|
0 +---* (101)-------------------------------------------------
2018 2020 2022 2024 2025
Explaining the 2025 Registration Spike
The registration volume remained relatively stable, averaging between 1,000 and 1,900 approvals per year between 2019 and 2024. This represented the steady-state capacity of DRAP’s manual review and the phased transition of existing market devices into the new regulatory net.
However, in 2025, the registration volume surged to 3,614 approvals — a 101% increase compared to the previous year. This dramatic spike was driven by two key factors:
- The Launch of the DRAP e-Service Portal: On July 21, 2025, DRAP launched its dedicated e-Service Portal (e.dra.gov.pk) — the online MDMC (Medical Devices & Medical Cosmetics) Licensing and Product Registration system — and stopped accepting manual submissions. The portal replaced the earlier paper-plus-USB dossier workflow with a streamlined digital channel, which reduced administrative processing bottlenecks and allowed the Medical Devices Board to clear a large backlog of pending applications.
- Enforcement Deadlines: The transitional provisions of the Medical Devices Rules 2017 reached their final enforcement phases in 2025. Unregistered imports faced strict rejection at Customs, forcing manufacturers who had previously delayed registration to submit and finalize their approvals.
For international companies, this data shows that DRAP's digital infrastructure is now mature. The online portal has successfully accelerated review timelines, making the Pakistani market more accessible for new product launches.
What is the DRAP regulatory regime (Act 2012, Medical Devices Rules 2017) behind this list?
The numbers on the DRAP list represent the output of a structured legal and administrative framework. To operate legally in Pakistan, manufacturers must comply with the following pillars of the DRAP regime:
1. The Legal Foundation
The Drug Regulatory Authority of Pakistan was established under the DRAP Act 2012 to replace the old Drug Control Organization and modernize the regulation of all therapeutic goods. The specific operational rules for medtech were formalized under the Medical Devices Rules 2017. These rules separate medical devices from pharmaceutical products, establishing distinct standards for quality systems, clinical trials, and registrations.
2. The Local Authorized Representative (LAR) Requirement
Foreign manufacturers cannot apply directly to DRAP for product registration. You must appoint a local partner who acts as your Authorized Representative (LAR).
- The LAR must be a legally registered company in Pakistan.
- The LAR must hold a valid Establishment License as an importer or manufacturer, issued by DRAP's MD&MC Division.
- The registration certificate is issued jointly, but the LAR is the legal holder of the registration in Pakistan. They control the import permits, meaning that choosing the right LAR is a major strategic decision.
3. Documentation and Standards
To register Class B, C, or D devices, the manufacturer must provide:
- ISO 13485 Certification: The manufacturing facility must hold a valid ISO 13485 certificate for medical device quality management.
- Reference Market Approvals: Pakistan heavily relies on "abridged" evaluation pathways. Providing proof of approval from recognized reference markets — such as the US FDA (510k/PMA), EU CE Mark (MDR/IVDR), Health Canada, Australian TGA, or Japanese PMDA — greatly simplifies the review process and is practically required to secure approval within the standard timeline.
- Labeling Compliance: Labels and instructions for use (IFU) must be in English. However, for home-use devices, DRAP requires critical safety information and basic instructions to be provided in Urdu, the national language.
4. Registration Validity and Renewals
DRAP registrations and enlistments are valid for 5 years.
- Renewal Window: Renewal applications must be submitted through the e-Service portal at least three months prior to the expiration date.
- Lapse Risk: If a registration lapses, the product is immediately blocked at customs, and the importer cannot secure import permits. A full new registration application may be required if the renewal window is missed, causing significant market supply disruptions.
Detailed Step-by-Step Registration Workflow via the DRAP e-Service Portal
Navigating the Drug Regulatory Authority of Pakistan (DRAP) registration pipeline requires a structured approach. Since DRAP launched its dedicated e-Service Portal (e.dra.gov.pk) for MDMC licensing and product registration on July 21, 2025 — after which manual submissions are no longer accepted — the submission and review process is executed online.
Below is the step-by-step operational workflow for foreign manufacturers and their local representatives:
+---------------------------------------------------------------------------------+
| DRAP e-Service Portal Registration Workflow |
+---------------------------------------------------------------------------------+
|
[Step 1: Establishment Licensing] -> LAR secures importer license from DRAP
|
[Step 2: Device Classification] -> Determine risk class (Class A to D)
|
[Step 3: Dossier Compilation] -> Prepare CSDT folder + Reference Approvals
|
[Step 4: Fee Payment & Portal] -> Deposit fee and submit via e-Service portal
|
[Step 5: Technical Review] -> MD&MC Division checks completeness
|
[Step 6: MDB Approval & Issue] -> Medical Devices Board issues Certificate
Step 1: Secure or Verify the Establishment License
A foreign manufacturer cannot initiate a registration on the e-Service portal. First, the chosen local partner must hold a valid Establishment License issued by DRAP as an importer or distributor of medical devices.
- Requirements: The local partner's warehouse must pass physical inspection by DRAP inspectors to verify temperature control, hygienic conditions, and storage capacity.
- Timeline: 2 to 4 months for new licenses.
Step 2: Product Classification and Determination of Pathway
Determine the risk class of the product (Class A, B, C, or D) based on GHTF/AHWP classification rules. If the classification is disputed or complex, the local partner can submit a formal Classification Request to the MD&MC Division.
- Select the Abridged Evaluation Pathway if the product already holds approval from the US FDA, EU (MDR/IVDR CE Mark), Health Canada, Australian TGA, or Japanese PMDA.
- Select the Standard Evaluation Pathway if no reference approvals are available (highly discouraged due to long review timelines and potential clinical trial requirements).
Step 3: Dossier Preparation and Common Submission Dossier Template (CSDT)
Compile the regulatory folder. Under the e-Service portal, the local representative must upload:
- Device Description: Intended use, clinical indications, and detailed material composition.
- Quality Management System (QMS) Evidence: Valid ISO 13485 certificate of the manufacturing site.
- Conformity Assessment Documentation: Certificate of Conformity from a Notified Body (for CE-marked devices) or FDA clearance letter.
- Free Sale Certificate (FSC): Legalized or apostilled document from the country of origin or a recognized reference market proving that the device is actively commercialized.
- Labeling Mockups: High-resolution packaging designs demonstrating compliance with English and Urdu language guidelines.
- Letter of Authorization: A legal agreement appointing the importer as the LAR in Pakistan, signed by the manufacturer and notarized.
Step 4: Portal Upload and Fee Submission
The LAR deposits the government fee at designated branches of the National Bank of Pakistan (NBP) and uploads the receipt to the e-Service portal.
- Fee schedules are updated periodically by DRAP and are bifurcated: a lower fee for Class A Enlistment and higher scales for Class B, C, and D registrations.
- Once the fee receipt is linked, the e-Service portal opens the dossier upload fields. The LAR enters the product attributes and uploads all technical files.
Step 5: Technical Evaluation and Deficiency Resolution
The MD&MC Division reviews the uploaded files.
- If the technical team identifies gaps (e.g., expired ISO certificates, missing Urdu safety labels, or unclear clinical studies), they issue an online Deficiency Letter.
- Critical Deadline: The LAR must submit replies and resolved documents through the e-Service portal within a specified timeframe (typically 30 to 60 days). Failure to resolve deficiencies results in the rejection of the dossier, forfeiture of the fees, and requires restarting the process.
Step 6: Medical Devices Board (MDB) Review and Approval
Once the technical evaluation is completed and all deficiencies are resolved, the MD&MC Division forwards the application to the Medical Devices Board (MDB).
- The MDB meets periodically to review and approve registrations.
- Upon approval, the system generates the electronic Enlistment Certificate for Class A devices or the Registration Certificate for Class B/C/D devices.
- The certificate is valid for 5 years and is accessible in DRAP's public registry.
Strategic Local-Partner and Local-Manufacturing Selection for Pakistan Market Entry
The quantitative realities of the DRAP register provide clear strategic directions for medtech companies looking to enter or expand in Pakistan:
1. Managing Channel Lock-in and Multi-Distributor Models
Because the DRAP registration is tied to the importer's Establishment License, a single local representative can effectively lock you out of the market if the relationship deteriorates.
- Recommendation: Structure your distribution agreements with clear provisions for the transfer of DRAP registrations. Alternatively, consider establishing a local subsidiary or working with a neutral third-party regulatory consultant who can hold the registrations as a neutral LAR, allowing you to appoint multiple commercial distributors.
- Compare with Regional Siblings: This channel lock-in is a common theme in emerging Asian markets. For instance, in our analysis of the Kazakhstan NDDA medical device registry teardown and the Uzbekistan medical device registry analysis, we find similar local-representative dependencies. Manufacturers who succeed in these regions always separate regulatory ownership from commercial distribution.
2. Exploring Local Manufacturing Partnerships
The presence of domestic players like Ferozsons (290 records) shows that Pakistan's local manufacturing capacity is growing.
- The Regulatory Incentive: DRAP offers lower registration fees and faster approval timelines for locally manufactured devices. Additionally, the Pakistani government actively prioritizes local manufacturers in public sector hospital tenders.
- Strategy: For high-volume, low-margin consumables (Class A and B), international firms should evaluate joint ventures or licensing agreements with established local players. This allows you to leverage their local manufacturing licenses and distribution networks while meeting the government’s local-sourcing preferences.
3. Preparing for the Online e-Service Portal Era
With 2025 proving that digital submissions are processed much faster, manufacturers should ensure their technical documentation is fully aligned with the e-Service portal's structure before starting. Having pre-cleared US FDA or EU CE certificates is the single fastest way to clear DRAP’s digital checkpoints.
Related Articles
To further refine your South Asian and Central Asian medtech market strategy, explore our companion guides:
- Pakistan DRAP Medical Device Registration, Classification, and Import Licensing Guide — Our detailed process guide covering how to compile a dossier, fee schedules, and importer licensing steps.
- Bangladesh DGDA Medical Device Registration Guide — A comparative look at Pakistan's neighbor, analyzing the Directorate General of Drug Administration (DGDA) framework.
- Kazakhstan NDDA Medical Device Registry Teardown — Exploring CIS market dynamics, regulatory hubs, and channel structures.
Disclaimer: The data presented in this article is based on a snapshot of the Drug Regulatory Authority of Pakistan (DRAP) registry dated August 28, 2025. Company record counts are approximate due to spelling and address variations in the official data. This analysis is for educational and commercial planning purposes and does not constitute formal legal or regulatory advice for specific products.