The article provides an overview of the new draft guidance and highlights the key points to be considered.
Table Of Contents:
The National Health Regulatory Authority (NHRA), a Bahrain’s agency responsible for healthcare products regulations, has published a guidance document dedicated to the registration of medical devices intended to be marketed and used in the country. The document describes the approach to be followed when applying for registration of a medical device before placing it on the market. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance thereto.
Regulatory Background
According to the guidance, registration of medical devices was initially introduced in 2015 in order to ensure compliance with the applicable safety- and effectiveness-related requirements, as well as traceability of the products marketed in the country. The applicable regulations provide that the registration should be carried out via the respective electronic system. The information to be recorded during the registration includes, inter alia, the name of the device in question, its serial number, the country of origin and the intended shelf life. The said electronic system could be used for the purpose of:
- Inventory and management of the information required to register medical devices and products and their facilities;
- A visualisation of the market size for medical devices and products in the Kingdom;
- Provide information on facilities engaged in the manufacture, distributors or importers medical devices and products in the Kingdom;
- Provide information on medical devices and products that will be marketed or already used in the Kingdom.
In accordance with the guidance, registration should be completed after validating compliance with the applicable regulatory requirements, as well as standards and guidelines. Furthermore, the authority intends to align the requirements with the ones introduced by the national regulating authorities in other countries.
General Rules
First of all, the document outlines the main rules to be followed, namely:
- Only registered authorized representatives can apply for medical devices registration;
- All medical devices must be registered regardless of its risk classification (class I, IIa, IIb, and III) / IVD (A, B, C, D);
- All registered medical devices will be published along with their authorized representative on NHRA website;
- All healthcare facilities will be instructed to purchase only registered medical devices to ensure the patient safety;
- Registration is not linked to HS codes being regulated by NHRA or not;
- Registration fees are now implemented;
- Classification criteria must be fulfilled before submitting for registration;
- All required official documents should be signed and stamped by the issuer;
- Form submitted must be electronically filled, searchable, not printed or scanned;
- Medical devices purchasing and marketing prices required in the registration form will be confidential and will only be used for study purposes only.
Apart from the ones listed hereabove, the authority also describes other general principles. The key points to be considered by medical device manufacturers are the following:
- The registration requirements do not apply to the accessories to medical devices and spare parts thereto. At the same time, in the case of importation, the applicant should provide evidence demonstrating relation to the initial medical device such product is intended to be used with. This can be provided in a form of an official letter issued by the medical device manufacturer.
- Under the general review, it will take from 40 to 80 business days to review the application.
- The authority is entitled to request additional documents, should such documents be reasonably necessary to complete the review of the application.
Submission Process
The document also describes in detail the processes and procedures associated with the submission of an application for medical device registration. According to the guidance, the set of documents should be submitted via email. Should it be determined that all the applicable requirements are fulfilled, a license valid for 1 year will be granted. At the same time, in case of any issues identified, the authority may reach out to the interested party and request additional actions to be performed. In such a case, an interested party will have two additional attempts to complete the actions requested by the authority while staying within the scope of the same application, otherwise, the application will be rejected, and a new one will be needed, resulting in the fees payable one more time.
Listing
The authority also mentions that all medical devices intended to be marketed and used in the country should be duly listed. This applies to the products that are imported or will be imported. In order to fulfill this requirement, the party responsible for a medical device should fill in the appropriate sheet and submit it to the authority via email. In this respect, the authority additionally emphasizes that listing should be submitted (including all medical devices) prior to submitting medical device registration applications and it should not be submitted as part of the medical device registration application.
Requirements of Medical Devices Registration
The document also outlines the scope of requirements to be fulfilled in terms of medical device registration in order for the device in question to be allowed for being placed on the country’s market. The respective section of the guidance includes a list of documents to be included in the application an interested party should submit when requesting a medical device to be registered. According to the guidance, the said list includes the following elements:
- Medical Device Registration form;
- Technical Details;
- Artwork;
- Agreement or Authorization letter;
- Official Letter;
- Instructions for use (IFU);
- List of countries;
- Bahrain market field safety notice records (for the products used at least for 3 years, or worldwide records;
- An official confirmation that field safety notice records are closed;
- List of End-users;
- Quality Management System Certificate;
- Quality Assurance Certificate (or a Declaration of Conformity for low-risk medical devices);
- EC Design examination certificate or an FDA Certificate to Foreign Government (for Class III general / Class D in vitro diagnostic medical devices);
- Verification evidence;
- Free Sale Certificate;
- Declaration of Conformity as per EU regulations issued by the legal manufacturer;
- A letter explicitly confirming that the device in question is free from porcine derivatives;
- NHRA classification letter; and
- A screen capture of the medical devices registration listing email.
In summary, the presented guidance document issued by the NHRA provides an overview of the applicable regulatory requirements in the sphere of registration of medical devices. The guidance describes the scope of documentation to be submitted when applying for medical device registration, as well as the particular steps to be fulfilled.
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