The Bosnia and Herzegovina Agency for Medicines and Medical Devices, the country’s regulating authority in the sphere of healthcare products, has published a user guide dedicated to the national information system for medical devices.
The present article describes the details on providing information about medical devices and also certain procedures associated with additions to and replacement of the information entered into the national register, while the previous article covers the aspects related to uploading and amending information on medical device manufacturers and manufacturing facilities.
Information About Medical Devices
According to the present user guide, an EC certificate (conformity certificate) is mandatory for any and all medical devices, except the low-risk ones. All certificates uploaded to the information system will be checked by the authority. The document also describes in detail the rules to be applied depending on the type of certificate in question and also the way the certificates should be combined. It is also necessary to indicate the expiry date of the certificate, as well as the name of a notified body by which it has been issued. The details of a notified body should also contain a reference to the particular framework (Regulations or Directives) under which it has been designated to conduct the conformity assessment of medical devices falling within the scope of the designation.
Apart from certificates, the information system allows uploading additional documentation reasonably necessary to complete the registration of a medical device. According to the user guide, the set of documentation required for the registration includes the following documents to be submitted by the applicant:
- Application form, duly filled and signed by the applicant. It should contain the name of the medical device subject to review, as well as an indication of its class under the risk-based classification.
- Excerpt from the court register confirming the registration of a legal entity, together with the information about activities it is entitled to perform and the name of a responsible person.
- Authorization letter, by virtue of which the manufacturer is allowed to enter a medical device into the information system. The letter should be provided in original or as a notarised copy certified in the country of origin.
- Confirmation for payment of an administrative fee.
- Confirmation for payment of expenses associated with registration of a medical device in a register of medical devices.
- Insurance policy, issued by an insurance company registered in Bosnia and Herzegovina (original or certified copy).
- Quality Management System (QMS) Certificate – it could be either ISO 9001:2015 or ISO 13485:2016.
- Duly filled and signed Appendix 1, containing information about the medical device.
- EC certificate (except the cases when it is not required – for instance, for low-risk medical devices).
- Declaration for Conformity with regard to the applicable EU regulations, indicating the class of the medical device (original or certified copy).
- Free Sale Certificate or similar document confirming that the medical device in question is allowed for marketing in the country of origin or in any country of the EU.
- Information about medical device (composition, brief description, intended use).
- Information about the expiration date and storing conditions.
- Information about packaging, shape, and materials used.
- Instructions for Use in the foreign language used in the country of origin, together with the translation in languages officially used in Bosnia and Herzegovina.
- Description of methods of sterilization and control (for sterile medical devices).
When uploading information about the medical device, the applicant shall provide the name of the product, indicated on its packaging, generic name of the product, model (as indicated in a Declaration of Conformity), details about shape and labeling, and a catalog number.
Mandatory information includes:
1. The brand name,
2. The generic name of a particular medical device, and
3. The intended purpose of a medical device.
The manufacturer can also indicate one or more manufacturing facilities that should already be entered into the Register. In such a case, the information system will automatically link the appropriate ISO certificate. The manufacturing facility could be added if the certificate has already been verified by the authority.
Initial Application for Registrations: Additional Aspects
Appendix 1 mentioned above contains additional documentation related to the medical device. The authority also mentions that in the case the applicant fails to provide such an Appendix, the application will be returned as incomplete, and the authority won’t proceed with further review unless it is duly completed.
Appendix 1 shall contain:
- Authorization letter, allowing the inclusion of a medical device into the Register,
- Declaration of Conformity (original or certified copy).
- Free Sale Certificate or similar document.
- EC certificate (when necessary).
Each request can be amended or modified before it is submitted to the authority for review. Should the submitted request be incomplete, the information system will display the appropriate notice containing the following elements:
- Indication of change to the request status,
- The date before which the submission shall be corrected,
- Indication of a reason for refusal – the deficiencies,
- Deficiencies` status.
In order to correct the deficiencies, the applicant shall open the relevant page and upload the appropriate document.
Modification and Renewal of Registration
In certain cases, the entity responsible for the medical device entered into the information system may have to make certain changes to the registration entry. All such changes should be implemented by virtue of separate modification requests. For this purpose, the responsible entity shall create a new request and choose the appropriate request type – “Modification”. Later it will be necessary to indicate the particular type of changes to be made – for instance, changes to the name of a medical device or its manufacturer. The same approach should be applied in case of changes to the expiration date or storing conditions.
The authority additionally mentions that the information system recognizes and identifies any and all certificates entered therein. Thus, it would be impossible to make changes to one element if such changes affect others.
As in the case of the request for initial registration, the request for modification should be supplemented by the relevant documentation, namely:
1. Application form indicating the number of all connected certificates and also information about the manufacturer.
2. Copies of the certificates that should be changed.
3. Renewed authorization letter covering amendments to the medical device registration entries.
4. Excerpt from the court register confirming the registration of a legal entity and indicating the name of a responsible person.
5. Insurance policy.
6. Confirmation of payment of an administrative fee.
7. Confirmation of payment of associated expenses.
The present user guide further describes in detail the requests to be submitted for modifying particular information associated with the medical device, such as the name of the manufacturer or changes to the manufacturing facilities. Depending on the nature of changes, additional documentation could be required. For instance, in case of significant changes to the medical device itself, the applicant would have to provide new certificates issued by the appropriate bodies.
In summary, the user guide issued by the regulating authority provides additional clarifications and recommendations to be considered when applying for registration of medical devices in the information system. The document describes various types of requests and the scope of information to be submitted in each case.
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