Permit To Use

Medical Device Permit to Use

Based on the circular issued on 19/03/2018, regarding National Registry of Medical Devices and based on resolution No. (48) of 2020 on Medical Devices and Products’ Quality Control, Article (8), which states that “all health care facilities must take Authority permit to use medical devices and products before using them.”

NHRA issued the circular to all healthcare facilities to note that this registration will be completed by the end of 2025, when all previously approved and permitted medical devices’ details will be uploaded on NHRA website.

Applicants have the option to submit through ADLIYA BUSINESS CENTER CO. W.L.L (ABC) (Fast track route) accredited by NHRA to facilitate the process of Permit to Use of medical devices, for healthcare facilities facing difficulties in preparing the required documents to speed up the approval process.

General Guidelines:
1. HCF management should ensure that all medical devices existing in the facility is listed and approved for use by NHRA.
2. Permit to use is mandatory for all HCF before purchasing/use new devices.
3. All Permitted to use medical devices will be labeled by NHRA label and listed on NHRA website as registered medical devices.
4. All medical devices must be imported and cleared as per NHRA regulations.
5. Medical devices should match with healthcare facility specialization.
6. Healthcare facility must ensure that the medical device is already registered in NHRA by the supplier before purchasing.
7. “Permit to use” has no validity and is not renewable.

Permit to use process is done through 3 phases:
Phase 1. Listing the medical devices
Phase 2. Providing the required QAC and information through Portal
Phase 3. Approved medical devices will be labeled and published on NHRA website.

Requirements:
1. A list of medical devices should be prepared by all healthcare facilities with clear description of medical device name, model, manufacturer name, serial number.
2. Valid NHRA Healthcare facility license.
3. Quality assurance certificate of the medical device. These certificates should be valid and with a scope matching with the function of the medical devices. (see verification guideline).
4. Invoice or OFOQ reference number should be provided for purchased medical devices since 2016.

Confiscated Medical Devices:
In case of confiscating medical devices by NHRA in violative healthcare facility due to many reason including
1. Using medical device in unlicensed healthcare facility.
2. Using medical device that is not approved by NHRA.
3. Using a medical device that is not matching with healthcare facility specialty.
The financial expenses of confiscated medical devices will be covered by the device owner.

• Medical Device Permit to Use Guideline.

• Medical Devices Violation Guideline .

• To Register.