West Bank Healthcare Sector & Medical Device Registration 2024 Overview

The Palestinian healthcare sector in the West Bank consists of the following four main providers of healthcare services: the Palestinian government (Ministry of Health and Military Medical Services), United Nations Relief and Works Agency (UNRWA), Non-Government Organizations (NGOs), and the private sector.  The Palestinian Ministry of Health plays a major role in maintaining the continuity of the Palestinian healthcare sector and providing high quality healthcare services.

In 2022, the total number of public, private, UNRWA, and NGO hospitals in the West Bank was 58 with an approximate capacity of 4,286 beds. The number of beds per 10,000 population was 13.4 beds and the number of hospitals for 100,000 population was 1.8 hospital.  During the same year, the total number of primary health care centers in the West Bank reached 608.  Most of the centers are associated with the Ministry of Health (72%), NGOs (19%), UNRWA (7%), and Military Medical Services (2%). Primary healthcare centers ensure Palestinians receive counseling, prevention, treatment, rehabilitation, and palliative care throughout their lifetime.  

The West Bank is heavily reliant on imported healthcare goods to meet local demand, thus representing a significant opportunity for U.S. exporters.  The U.S. market share is approximately 15% of the total and there is room for increased U.S. exports as American-made products are valued for their quality.  There are no import duties on U.S. made goods entering the West Bank including healthcare products however they are subject to Value Added Tax (VAT) at the rate of 16%.
 

Medical Device Registration Requirements (Checklist for U.S. Exporters)

To introduce, distribute, or use medical devices in the West Bank, the goods must be registered with the relevant department and in accordance with the provisions of the following instructions:

• Registration application form.
• Commercial registry for the business issued by the Ministry of National Economy.
• A valid agency registry (authorized agent or distributor) issued by the Ministry of National Economy.
• A valid business license issued by the Licensing Unit, Ministry of Health.
• Original and duly certified authorization from the manufacturer to register the medical device at the Ministry of Health.
• Declaration of conformity issued by the manufacturer.
• Original certificates for any of the following:
  - European Conformity Certificate (CE) issued by a body accredited with health authorities in the European Union (Notified Body).
  - Certificate to Foreign Governments issued by the Food and Drug Administration (FDA). 
  - Original and certified Free Sale Certificate issued by health authorities in the country of origin, and another Free Sale Certificate in one of the following countries (Switzerland, Australia, Canada, Japan, or Norway) according to the medical device category. 
• A valid and notarized (ISO 13485) certificate from the manufacturer.
• Technical file (if the medical device is in the form of a pharmaceutical preparation or contains a medicine): 
  - A certificate, signed and stamped by the manufacturer, for the composition of the preparation with the proportions.
  - Finished product specifications.
  - Methods of analysis for active ingredients.
  - Certificate of analysis.
  - A declaration of the shelf life and storage conditions from the manufacturer.
  - TSE/BSE free certificate.
  - Stability study for one batch according to the requirements of the (ICH Guidelines).
  - Sufficient samples for analysis of the finished product, and reference materials and their certificate of analysis for quantitative testing. 
• A copy or photo of the outer pack and labels. 
• A returnable sample of the medical device.
• A copy of the leaflets.
• Catalogues, brochures, and use instructions.
• Any other needed documents.

For additional information on the healthcare sector in the West Bank or how to register your medical device products, please contact Assad.Barsoum@trade.gov.