Analysis of Key Points in the Registration of Medical Devices Exported to Pakistan

Although Pakistan is primarily an agricultural country, its large population base andMedical EquipmentIts high dependency makes it a market of focus for medical device manufacturers. For companies seeking to enter this market, understanding the key points of medical device registration in Pakistan is crucial for success.

(1)Demographic and Economic BackgroundPakistan has a population of 240 million. Despite its relatively weak industrial base, there is substantial demand for imported medical devices, particularly Chinese-made products, which are favored by local healthcare providers for their affordability and diverse range.

(2)Market PotentialGovernment healthcare expenditure has been increasing annually, with the latest data showing annual spending reaching $785 million. Market analysis predicts steady growth in Pakistans medical device market from 2022 to 2027, with rising demand for various medical devices.

(3)Sino-Pak Medical TradeAs a close neighbor of China, Pakistan shows high acceptance of Chinese-made medical devices. Chinese manufacturers, with their comprehensive product lines and competitive pricing, have become preferred partners for Pakistani healthcare providers.

(1)Regulatory AgencyThe Drug Regulatory Authority of Pakistan (DRAP) is the primary official agency responsible for medical device registration and regulation, overseeing the entire process from registration to market surveillance.

(2)Cooperation and CommunicationDRAP maintains close collaboration with stakeholders to ensure effective implementation of regulatory policies, providing necessary guidance and support to help companies successfully complete the registration process.

(1)Applicant EntityImporters, distributors, or authorized local third parties can serve as registration applicants, but they must hold a license to import and distribute medical devices in Pakistan.

(2)Registration Exemptions and RequirementsFor high-risk Class C and D products, registration exemptions are valid until December 31, 2023, while low-risk products enjoy an extended exemption until December 31, 2024. Although some products are exempt from registration, submitting technical documentation remains mandatory.

(3)Technical Documentation SubmissionAll products applying for registration must submit paper-based technical documentation to DRAP and ensure the products are registered in GHTF5 countries and have obtained registration certification from their country of origin.

(4)Post-Market Management and SupportAs the holder of the registration certificate, the company is responsible for post-market surveillance and assisting customers with import authorization procedures.

Understanding and complying with local registration requirements and regulatory provisions are key to entering and succeeding in this market. Close cooperation and effective communication with DRAP ensure smooth registration processes.