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Expert Rev Med Devices. 2016 Jul;13(7):683-96. doi: 10.1080/17434440.2016.1195256. Epub 2016 Jun 15.

Accessing the medical devices market in Egypt and Saudi Arabia: a systematic review of policies and regulations.

Author information

1
a Interdisciplinary Centre for Pulic Health and Health Technology Assessment (HTA) , Friedrich-Alexander-Universität Erlangen-Nürnberg , Germany.
2
b Shamseya for Innovative Community Healthcare Solutions , Cairo , Egypt.
3
c National Cluster of Excellence , Medical Technologies-Medical Valley EMN' , Erlangen , Germany.
4
d The World Bank , Washington , DC , USA.

Abstract

INTRODUCTION:

Despite the significant medical devices market size in Egypt and Saudi Arabia, information regarding policies and regulations for medical devices market access is highly deficient.

AREAS COVERED:

The aim of this paper is to provide a systematic review on market access policies and regulations in both countries, to allow safe and timely access to medical technology. The following databases were searched: PubMed, Science Direct, Scopus, and Al Manhal Arabic database. Additionally, the web portals of regulatory authorities of both countries were searched. There are 34 records included in the qualitative synthesis of this review. Expert commentary: Main findings include; adopted regulatory framework from reference countries, and interim main regulatory documents, In conclusion, the market access schemes are relatively structured. However, some recommendations are put forward to navigate towards a more comprehensive policy framework in both countries.

KEYWORDS:

Egypt; Medical device; Middle East; Saudi Arabia; health technology assessment; health technology regulation; market access; medical technology

PMID:
27268662
DOI:
10.1080/17434440.2016.1195256
[Indexed for MEDLINE]

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