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Middle East

The Middle East medical device market is considered a manufacturer’s future high growth market. Saudi Arabia, UAE, Turkey, and Israel are considered large markets in terms of size and expenditure capacity. From a Regulatory standpoint, most countries have their own systems in place but at various stages of evolution. OMC Medicals offers assistance with the various regulatory requirements of middle east countries. 

Middle East

Armenia
Bahrain
Bangladesh
India
Indonesia
Iraq
Israel
Japan
Jordan
Kazakhstan
Kuwait
Kyrgyzstan
Laos
Lebanon
Malaysia
Maldives
Myanmar
Oman
Pakistan
Philippines
Saudi Arabia
Singapore
South Korea
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Syria
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U A E
Uzbekistan
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Middle East Key changes:

The Middle East medical device market is considered a manufacturer’s future high growth market. Saudi Arabia, UAE, Turkey, and Israel are considered large markets in terms of size and expenditure capacity. From a Regulatory standpoint, most countries have their own systems in place but at various stages of evolution. OMC Medicals offers assistance with the various regulatory requirements of middle east countries.
  • Kingdom of Saudi Arabia (KSA)- SFDA regulatory requirements have extended from 2019 making the requirements looks more complex and complicated; Audits by SFDA is also conducted to check compliance.
  • Bahrain- New regulations along with PMS requirements are released which shadows SFDA.
  • Kuwait- Medical device listing is required for import and single license can be obtained for temporary period for private patients use.
  • Turkey- Must have a CE mark and registered with the Turkish Drug and Medical Device National Databank.

ROW ( Eastern Europe, Asia )

  • Pakistan- Regulatory requirements are released in 2018 and requires long list of documentation for Market Access.
  • India- Medical devices regulations are released from 2019 and required a lot of detailed manufacturing process information to obtain license which takes from 1-2yrs
  • Bangladesh- Directorate General of Drug Administration regulates the registration requirements; Guidelines for medical devices are released.
  • China- Extensive regulation exists with samples for inspection and permit is obtained between 2-6 months.
  • Ukraine- Registration is required; In 2019 regulations of conformity assessment were amended.
  • Russia- Registration in Russia is required with the new rules from 2019 adding to its complexity; Many medical device registrations were rejected last year specially looking for details in the functionality of the equipment. we will help you keep updated with the requirements and market access.
  • Kazakhstan- Medical device registration is required which requires a long list of documentation. we could also check if you require meteorological committee assessment by the Kazakh authorities.
  • Uzbekistan- Registration is required by Ministry of Health of the Republic of Uzbekistan and may require an audit to ensure continuous market access.
  • Belarus- Registration is required by the Ministry of Health of the Republic of Belarus. Registration takes 3-6 months.
  • Kyrgyzstan- Medical devices can be sold after a state registration is completed, where the approval process is from 1-6 months.

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