Medical Devices & Supplies Control Section

Professionals & Facilities



A:
  • The person who experienced the problem.
  • A relative or guardian of the person concerned.
  • A representative chosen by the person concerned for the purpose of making the complaint.
  • A health service provider.
A:A complaint may be made to the NHRA about any health service provider in the Kingdom of Bahrain. This includes:  
  • Practitioners such as doctors, nurses, dentists, pharmacists, physiotherapists, paramedics and other allied health professionals regulated by the NHRA.
  • Health service organizations such as public or private hospitals, clinics, medical centers, day surgery centers, the Ambulance Service and others, affecting the clinical care or treatment of an individual.
  • The complaint can be made about the health service provider professional conduct and/or the clinical care and treatment provided or fitness to practice.
A:

Once the NHRA receives a complaint, it will be allocated to our concerned staff who will be managing the complaint through the assessment process. The NHRA usually notifies a health service provider that a complaint has been made about them. The NHRA will usually give the health service provider a copy of the complaint and ask them to provide a response within 2 weeks.

Occasionally, the NHRA may decide not to notify the health service provider of the details of the complainant. This is done only where the notification would put at risk the health or safety of a person, prejudice an investigation, place a person at risk of intimidation or affect the employment of an employee of a provider. If a complainant believes that any of these may occur in respect of their complaint, they must clearly explain why in their written complaint.

The NHRA has internal/external Professional Advisors who can review the complaint and provide clinical advice. When the NHRA has conducted a preliminary investigation and obtained all relevant information, the complaint will be referred to the concerned disciplinary committees for more detailed investigation including calling the professional for verification of information and /or disciplinary proceedings. If the concerned health professional/facility has been referred for a disciplinary process, a notification letter including the violations will be sent and the professional will be called to present in front of the disciplinary committee and will also be given time to submit a written defense. Once a final decision is made and endorsed by the supreme health council, the concerned health care provider will be notified of it in writing. A health care provider has the right to lodge an appeal against a disciplinary decision within 14 days from the date of receiving the decision.

Your response to a complaint should be made in writing and include the following:
  • State what has been done to investigate the complaint
  • State what has been / could be done to address their concerns
  • Mention any changes or actions taken or that are being considered as a result of the complaint
  • Offer of an opportunity to discuss the complaint further
  • Reassure the person that they can receive further service, if needed, without any concern about having made a complaint
  • Provide your perspective in relation to the complaint
A:When you receive a complaint, it is recommended that you consult with a relevant senior person - supervisor, manager, consultant, and your insurer (if applicable), while keeping in mind the obligation to protect the confidentiality of the complainant. If you are employed in the Public Sector you may wish to contact the Ministry of Health.
A:
  • Provide advice to the health service provider, for example, where the matter was not serious enough to require disciplinary action, but perhaps the service provider could avoid a recurrence of the incident in the future. A typical example might be where a communication issue has arisen between you and the healthcare provider.
  • Ask the health service provider to do the necessary corrective measures where the matter was related to the regulatory laws, regulations and standards of NHRA.
  • Refer the complaint to the relevant service provider, to resolve the complaint directly with complainant
  • Refer the complaint to another appropriate government department or institute for their management. For example, it may be more appropriate for the matter to be dealt with by the Consumer Protection Directorate of the Ministry of Industry and Commerce, in order to assist or advise you regarding your consumer rights and/or the service provider’s obligations
  • Refer the complaint for the concerned disciplinary committees for more detailed investigation and /or disciplinary proceedings.
  • Take no further action regarding the complaint
A:

Following the assessment, the NHRA may discontinue dealing with a complaint (or any part of a complaint) for any one or more of the following reasons:

  • The complaint (or part) is frivolous, vexatious or not made in good faith
  • The subject matter of the complaint (or part) is trivial or does not warrant investigation, or resolution, or the NHRA dealing with it
  • The subject matter of the complaint (or part) has been or is under investigation by some other competent person or body, or has been or is the subject of legal proceedings
  • The complaint (or part) has been referred by the NHRA to another person or body for investigation or for consideration of other action.
  • There is or was, a better alternative means of dealing with the matter available to the complainant and the complainant does not have a good reason for not pursuing that alternative (for example, a healthcare facility may be willing to provide the information required by the complainant, but the complainant has not pursued that course.)
  • The complainant has failed, without sufficient reason, to provide further particulars of the complaint (or part) within the time specified by the NHRA
  • The complainant has been submitted far beyond the period specified for the retention of the medical records.

The above are only examples and not a full list of the circumstances in which the NHRA may discontinue dealing with a complaint (or part). The NHRA must not discontinue dealing with a complaint (or part) if it appears to the NHRA that the complaint (or part) raises a significant issue of public health or safety. If the NHRA discontinues dealing with a complaint (or part), the complaint (or part) is terminated.

A:
  • The NHRA acts to protect the public health and safety. It does not represent individual interests.
  • The NHRA has the right to continue investigating a complaint if it was withdrawn by the complainant if it appears to represent a significant issue of public health or safety.
A:
How can I resolve concerns about the health care I have provided?

It is generally recommended to deal with complaints directly when they occur and try to resolve them locally with the patient or person that complains. It is important to keep in mind that people generally complain because they are dissatisfied. While it can be upsetting to receive a complaint about the care you have provided, a complaint can be an opportunity to increase understanding of the patient's perspectives. It can also help to improve the service that you offer.

Please remember that the person making the complaint may have found it quite distressing to do so and may have had difficulties in putting their experiences down on paper. In the vast majority of situations, people make complaints because they genuinely believe that something went wrong. Only very few people complain just to cause trouble.

How do I respond to a complaint and what does it need to include?

Every complaint is different, so the approach to resolving it will differ depending on:

  • The nature of the complaint (the seriousness and the complexity)
  • The complainant's wishes
  • The issues the complaint raises
  • How the complaint came to you

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