MDR (Medical Device Regulation)

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Medical Devices Destruction



Disposal of Medical Devices

Disposal of Medical devices in Kingdom of Bahrain is done through below companies:

Bahrain Waste Treatment

Email Address: patbranay@gmail.com

                             bwtc@Batelco.com.bh          

Telephone No. : 17754909 / 17754727

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Crown Industries

 

Website: https://www.crownbahrain.com/

Email: crownmet@batelco.com.bh

Telephone No. : 17 830038

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1- Incase of disposing of medical devices in Kingdom of Bahrain, NHRA should be informed by submitting Medical Devices Destruction Supervision Form at medical_devices@nhra.bh.

 

2- After submitting the required documents, applicant will receive a NTP to pay the fees for destruction supervision (please refer to Fees guideline)

 

3- For more information and explanation about Disposal of Medical Devices, please refer to Guideline or watch the Video.

 


Pre Market


First, before importing or registering medical devices, you must be registered as an authorized representative in NHRA by applying and obtaining a license to import and register medical devices.


Secondly, classify medical devices by making sure that they are listed under medical devices or other category by applying for classification.


Third, submitting an application to register medical devices to facilitate the importation process into the Kingdom of Bahrain by applying for registration of medical devices.

On Market

Controlling medical device importation at the ports of entry where importers must submit an application through Ofoq website and submitting the required documents to obtain NHRA approval before importing medical devices.

Regulating advertisements for medical devices based on Decision (48) 2020, Article (10) “It is forbidden for any person to market or advertise the medical device and product unless obtaining a license from the Authority.


Post Market

Decision (48) 2020, Article (16) intended to guide and encourage all healthcare facilities, importers, patients and professionals to the importance of reporting problems associated with medical devices, including:

Permit To Use

Field Safety Notice and Recalls

Adverse Events and complains

Medical Devices Destruction

Healthcare Facilities Inspection