MENA Is Moving Into a Regulated Medical Device Environment!

 

MENA Is Moving Into a Regulated Medical Device Environment!

 

Your product is classified as a medical device and you want to launch it in the Middle East and North Africa Region? Well, unlike before you will have to start by an official registration in most of the MENA countries. Previously, some regulatory papers such as a CE document, an FDA approval and an ISO certificate were enough to issue an import approval for any shipment of medical devices.

Therefore, now is the appropriate time for you to choose your regional regulatory consultant to work together on a successful regulatory roadmap to make sure you achieve your market access plan successfully.





Medical Device Regulation

In 1992, the Global Harmonization Task Force (GHTF) was founded in response to the growing need for international harmonization of medical devices regulation. In 2006, the membership was expanded to include the Asian Harmonization Working Party (AHWP), the International Organization for standardization (ISO), and the International Electro technical Commission (IEC). (1)

The GHTF proposed the following harmonized definition of a Medical Device (2)

‘Medical Devices’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of Medical Devices, providing information by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.‘




Medical Device Regulation in MENA

In MENA, the registration of medical devices in comparison to pharmaceutical products is less regulated. However, this has been tremendously changing and we can almost see every day new circulars coming from different countries to regulate the importation of medical device. The guidelines issued are more or less similar to the regulations developed by international organizations such as FDA and EU.

The minimum requirements for the registration are the following:

-Appointment of a local representative

-ISO certificate

-Quality documents (CFG/CE/QA/DoC)

-English labeling

Other than the mentioned above requirements, regulations differ from country to country (manufacturer registration, license validity …) which makes the registration process a laborious, time-consuming and expensive operation for companies looking to expand in the region. This justifies why local regulatory expert in these countries are indispensable.

 

 

  • Regulation of medical Devices outside the European Union, Version of Record - Apr 1, 2012 (24.05.2014) http://jrs.sagepub.com/content/105/suppl_1/S12.full.pdf+html
  • GHTF/SG1/N071:2012, Definition of the Terms ‘Medical Devices’ and ‘In Vitro Diagnostic (IVD) Medical Devices’(24.05.2014)