The new article addresses the aspects related to possible changes to an existing license, including the transferring local representative, renewal, and manufacturer acquisition.
Table Of Contents:
The National Health Regulatory Authority (NHRA), a Bahrain’s agency responsible for medical devices regulations, has published a guidance document dedicated to registration of medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers various matters related to the procedures associated with obtaining a medical device license, as well as making changes thereto. The authority explains each of the key points and detail and highlights the aspects to be considered by registration holders.
Transferring Local Representatives
A foreign medical device manufacturer may apply for transferring authorization from one representative to another. In accordance with the applicable legislation, such change will be considered as a minor variation, hence, this will not affect the registration or validity period of the certificate issued. In order to apply for such changes, the manufacturer should provide the following documents:
- Official letter issued from the new authorized representative stating the full responsibility of the medical device and full handover for the device data have been delivered to the new authorized representative, including: Distribution records, Recalls and Adverse events, Maintenance records (if any).
- Authorization letter issued from the manufacturer to the new authorized representative.
License Renewal
Another important aspect addressed in the guidance relates to the medical device registration license renewal. In accordance with the existing regulatory requirements, a license holder should submit an application for the license renewal not later than 1 month before the end of its validity period. The appropriate application form should be accompanied by the following document:
- An official letter issued from the legal manufacturer stating whether there are changes/updates done to the medical device/s or not;
- Requirements number 8,9,10, and 14 in “Section 5” in the guideline should be submitted (updated and newly issued) and the updated details should be highlighted (if any).
The above provision refers to the following documents:
- Field safety notice records;
- Details about the actions taken with respect to such letters;
- List of end-users; and
- Verification evidence.
According to the guidance, the list described herein above applies in the case of medical devices for which the license certificate has been issued after October 2020. In the case of the products registered before that date, a complete list of documents requested during the initial registration will be required.
Manufacturer Acquisition
The document also describes the course of action in case of manufacturer acquisition defined as a situation when one medical device manufacturer purchases all or most of the shares of another manufacturer, obtaining an actual control over the latter. From a regulatory standpoint, such an action will be considered a variation. Furthermore, the authority will assess the documentation provided and determine whether it is a minor or major variation. The set of documents to be provided in such cases includes the following ones:
- New/old artwork (the authority additionally emphasizes that the existing differences should be highlighted);
- Agreement / Letter of acquisition signed and stamped by both manufacturers stating the roles and responsibilities of each entity and explaining the impact of the acquisition on the medical device in the market;
- Official declaration issued from new manufacturer stating that all acquisition changes has been clearly declared to NHRA with supportive documents;
- Quality certificates (QAC, QMS) for new manufacturer;
- Free Sale Certificate;
- List of affected medical devices by the acquisition in the Bahrain market;
- Technical details.
Cancellation of Registration
The guidance also outlines the reasons why medical device registration can be canceled, resulting in the authorization holder being prevented from supplying medical devices on the market. According to the document, potential reasons for cancelation include:
-
- Expiration of the QAC / QMS without being renewed, or their invalidity, provided no justification was received by the authority;
- Major variation.
- A recall was initiated with respect to the device in question, or it caused an adverse event with severe consequences;
- A registration holder failed to apply for renewal of registration in time;
- CR expired/deactivated due to violations causing a delay in renewal application;
- An agreement concluded between a foreign medical device manufacturer and its authorized representative based in Bahrain is terminated or for any reason no longer valid;
- Relationship letter gets canceled for reasons such as changing the physical manufacturer and NHRA not being informed of variation.
It is also important to mention that apart from the reasons outlined hereabove, the authority may determine other reasons for the registration to be canceled.
Medical Device Registration: Steps
The document also provides a flowchart illustrating the whole registration process in general. As described in the flowchart, this process includes the following consequent steps:
- Preparation of the dossier by an authorized representative;
- Booking an appointment by the virtue of the respective system;
- Submission of the documents needed at the time of appointment;
- Review of the documents submitted by the authority;
- If the requirements are not fulfilled, the application will be rejected, otherwise, the authority will proceed with the next step, which is
- Final review and quality document verification, upon successful completion of which the license will be issued, while in case of a failure the application will be rejected.
In summary, the present NHRA guidance provides an overview of the existing regulatory requirements in the sphere of medical device registration in Bahrain. The document also pays attention to certain specific aspects, including the ones related to the renewal or cancellation of medical device registration.
Sources:
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
