MDR (Medical Device Regulation)

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1- Resolution No. (24) for 2021 Amending some provisions of Resolution (20) for 2016 on the definition of fees for private healthcare facilities

2- Guideline

 Medical Device/AR registration
Classification
Destruction

                       


                        MD Importation                                                                                                                                                                                                                                                                                                                                                              



Process:

Once Notice to Pay (NTP) is issued, fees can be paid by Electronic Fund Transfer System through Fawateer Offline Direct Bill Payment Services. Customers/corporates can use Fawateer services by visiting their banks branches, internet banking (retail and corporate), in addition to their banks mobile banking and applications (Benefit pay).

Please follow the below steps to pay by Fawateer:
1- Login to your internet banking, benefit pay, mobile banking or ...etc.
2-Search for National Health Regulatory Authority or NHRA from Fawateer bills list, it’s available within Medical & Health category.
3- Insert the total amount of the Notice to Pay and then submit, please note that it’s free of bank charges.
4- Finally, resend the Notice to Pay and the proof of payment (Transaction Summary) to the same email to get an official receipt and deliver the service. If you have more than one Notice to Pay, please use a separate Fawateer transaction for each Notice to Pay.


2- Payment Method of NHRA Fees


3- Payment Process for Medical Device fees Video		 Process:

• Create and store the application on OFOQ system with the required documents. 

• Send an email to MDRFees@nhra.bh to request a payment notice and include The License reference number of the application, the commercial registration (CR) number of the company, the applicant contact information such as name, email address, and phone number. 

• The Applicant will receive a notification by email or/and phone with a link to proceed with the payment via FAWATEER.

• After payment is done, the application status will be changed from “stored” to “requested” and will be reviewed and processed afterwards.


2- Payment Method of NHRA ofoq Fees


3- video on ofoq fees implementation 

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