Oman Medical Device Regulations

Regulatory Agency

The Ministry of Health (MOH) - Sultanate Oman, the Directorate General of Pharmaceutical Affairs and Drugs Control Medical Device Control Department (DGPA &DC) regulates medical devices in Oman.

Medical Device Definition

Medical Devices: are defined as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment, or alleviation of disease,
diagnosis, monitoring, 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.
They do not achieve their primary intended action by pharmacological, immunological, or metabolic means in or on the human body but may be assessed in their intended function by such
means.

Medical Device Classification System

It should be according to the Country of origin Jurisdiction and it may be subject to reclassification at a later stage.
In Oman, they Classify the product in regards to their severity in general to Low Risk, Medium-High Risk, and High Risk, and they will accept the classification as per the following table:

Severity	Class	Risk Level
Low	Class A	Class I
Low-Moderate	Class B	Class II/Class IIa
Moderate-High	Class C	Class IIb/Class III
High	Class D	All other Class III/Class IV/AIMD

Regulatory Approval Process

Pre-Market Approval Procedure “Listing Procedure”:

Registration of Medical Devices in Oman is still not implemented (Published Guidelines for the registration are still Draft guidelines). Medical devices shall only be imported, placed on the market, and/or put into service within the Oman market if it is listed in medical device control department databases.

List of Required Documents Steps to do the listing:

Appoint Omani Authorized Representative.
Medical devices shall not be imported, placed on the market, and/or put into service within Oman unless they are listed in the medical device control department databases.
If there are two suppliers for the same product, both should submit the listing.
Submit the requested listing Excel sheet and information through the following portal: https://eportal.moh.gov.om/eServices/Login?%20st=C9E847A4-E619-43A6-93D2-BBD0C6032FC
A listing party providing information to an existing database should submit all necessary information to the regulatory authority when it supplies the device to the market for the first time.
The authority shall receive databases of medical products and devices from the supplier companies and include them in the master list.
On a periodic basis, not more frequently than annually, each listing party shall be requested to confirm that the information provided for listing purposes continues to be accurate.
The listing party is required to update the information provided within 30 calendar days of becoming aware of the occurrence of any change or when requested to do so by the Regulatory Authority to maintain the accuracy of the listing database.
The Regulatory Authority may retain an archive of medical devices that are no longer being supplied to the market.

Additional Information

Approval timeline	Class A and B- 60 working days, Class C and D- 60 working days
License validity period	The registration process is still not implemented so there is no Registration Certificate validity announced and the applicant shall follow the listing procedure to import Medical Devices in Oman.
Fees	Class A and B- 100 OMR (Omani Rial), Class C and D- 200 OMR (Omani Rial)

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