Pakistan Medical Device Registration
Important Notes
- DRAP Registration: All medical devices require mandatory registration with the Drug Regulatory Authority of Pakistan to obtain a registration certificate for import, manufacture, or sale.
- Local Authorized Agent Requirement: Foreign manufacturers must appoint a locally registered Pakistani company (importer/agent) as the registration holder to submit applications and assume all regulatory and legal responsibilities.
- Technical Documentation & WHO Prequalification: Complete English technical documentation is required. DRAP places high value on WHO Prequalification (PQ) and approvals from Stringent Regulatory Authorities (e.g., FDA, EMA), which can simplify or expedite review.
- Labeling & Language Requirements: Medical device labels and instructions must be in both English and Urdu. Core information (name, warnings, expiry, storage) must be clearly displayed in both languages.
- Price Control & Maximum Retail Price (MRP): Registered medical devices must undergo price registration with DRAP, and the government-approved MRP must be printed on packaging; selling price cannot exceed MRP.
- Local Testing Requirements: Registration typically requires sample submission to DRAP-designated labs in Pakistan for testing or providing a Certificate of Analysis meeting applicable standards.
Pakistan Specific Requirements
- Large Population-Driven Price-Sensitive Market: As the world's fifth-most populous country, the market is vast but with limited purchasing power, dominated by cost-effective medical devices where price competition is extremely intense.
- Parallel Public-Private Healthcare System: The public system provides basic care but is resource-constrained; the growing private sector (hospitals, clinics, diagnostic centers) is the main channel for innovative and higher-value medical devices.
- Reliance on International Reference Approvals: With limited resources, DRAP's review often references existing approvals from WHO, FDA, EMA, etc. International certification serves as a crucial "fast-track" passport for medical devices.
- Rise of the Local Medical Device Industry: Domestic companies are growing in strength, becoming not only market competitors but also potential manufacturing partners or licensees for international firms.
- Stringent Price Control & Supply Chain Challenges: Strict price controls squeeze profit margins, while currency volatility, complex customs clearance, and distribution logistics pose ongoing operational hurdles for medical device suppliers.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Classification Management by Risk Level (Class A, B, C, D)
- Complete Technical Documentation and Test Reports
- Quality Management System Certificate (ISO 13485)
- English/Urdu Bilingual Labeling
- Free Sale Certificate
- Certificate of Origin
- GMP Certificate
- Stability Study Data
- Pakistan Local Agent Agreement
- Local Test Reports
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Agent Appointment
- DRAP Application Submission
- Sample Testing Completion
- Registration Certificate Acquisition
Registration Timeline
12-24 months
Official Fees
PKR 150,000 - 3,000,000
Service Fees
$15,000 - $48,000
Regulatory System Overview
DRAP
Drug Regulatory Authority of Pakistan
Responsible for medical device registration approval, import licensing, quality supervision, and market regulation. Operates as the primary medical device regulatory authority under the Ministry of National Health Services, Regulations and Coordination, Pakistan.
PSQCA
Pakistan Standards and Quality Control Authority
Responsible for developing mandatory medical device standards, conducting product certification and testing, ensuring specific device categories comply with Pakistan national standards.
M/o NHSR&C
Ministry of National Health Services, Regulations and Coordination Pakistan
Responsible for developing national health policies, medical device regulatory frameworks, and public health standards, overseeing DRAP operations and enforcement.
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to Pakistan medical device regulations (Class A-D)
Technical Documentation Preparation
Prepare complete technical documentation including product specifications, test reports, quality system certificates
Local Agent Appointment
Appoint authorized agent in Pakistan responsible for registration and regulatory affairs
DRAP Application Submission
Submit medical device registration application and all technical documents to DRAP
Sample Testing
Complete mandatory product testing in Pakistan accredited laboratories