The article provides an overview of the regulatory requirements for custom-made medical devices intended to be used in Bahrain and also describes in detail the documentation to be submitted by an interested party when applying for marketing approval.
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The National Health Regulatory Authority (NHRA), Bahrain’s agency in the sphere of healthcare products, has published a guidance document dedicated to custom-made medical devices. The document provides an overview of the applicable regulatory requirements set forth under the existing framework, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance therewith.
At the same time, provisions of the guidance are non-binding in their legal nature, and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. The present document constitutes the initial version of the guidance published by the authority in June 2023.
Regulatory Background
First of all, the document explains the concept of a custom-made medical device. According to the guidance, it means any device specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person’s professional qualifications that has, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
The present document is intended to provide additional clarifications regarding the applicable regulatory requirements intended to replace the CE certification, as well as verification thereof. At the same time, the authority mentions that other requirements outlined in the guidance document dedicated to importation would still be applicable.
Submission Requirements
In order to assist the parties involved, the authority outlines the scope of information and documentation to be submitted by the medical device manufacturer or its representative with the product intended to be used in the country. According to the guidance, the documents to be submitted should include:
A statement indicating the name and address of the medical device manufacturer, as well as the details of all the manufacturing sites involved, and also the same details for the authorized representative; the details necessary to identify the product subject to review, a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym, or a numerical code; and also the name of the person who made out the prescription and who is authorized by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned. Apart from that, the said statement should also describe the characteristics of the device in question in line with the respective prescription.
The applicant is also expected to include a statement confirming compliance with the product with the applicable safety and performance requirements set forth for devices of this type, while in the case of any non-compliances, the appropriate justification is to be provided. Should the product in question contain medicinal substances or human/animal tissues, the appropriate information should be included as well.
According to the guidance, the manufacturer should also issue a declaration covering the aspects related to compliance with the applicable regulatory requirements in terms of manufacturing procedures and record-keeping. With respect to the latter, the authority mentions that documentation related to general medical devices should be kept for 10 years for general medical devices and for 15 years for implantable ones.
The manufacturer is also responsible for reviewing and documenting the data collected during the post-production phase. Based on this, necessary measures could be developed and implemented in order to ensure the continuous safety and proper performance of the device. Moreover, custom-made products are also subject to incident reporting requirements – the authority should be duly notified about any serious adverse events associated with the device or field safety corrective actions implemented in response.
Local Clinic Prescription. Due to their nature, custom-made medical devices are initially manufactured to meet the needs of a specific patient. In order to ensure this, custom-made medical devices are being manufactured based on the prescription detailing the information about the patients and his/her needs as specified by the healthcare professional responsible for the process. Thus, in order to ensure the device fits the needs of a patient, all the important variables should be duly addressed in the said prescription.
In summary, the present NHRA guidance provides a brief overview of the regulatory requirements for custom-made medical devices as set forth under the existing legal framework. The guidance also outlines the scope of documentation and information to be submitted by the party responsible for the medical device with respect to the product in order to demonstrate compliance with the applicable regulatory requirements the product is subject to.
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