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.
General Information About the User Guide and Register
The document covers such questions as:
- Adding information about a medical device manufacturer, uploading certificates,
- Adding information about manufacturing facilities and uploading ISO certificates associated thereto,
- Amendments to certificates,
- Entries related to medical devices – regulatory requirements for the information to be provided,
- Changes to the name of medical device manufacturers, information about manufacturing facilities or the medical device itself,
- Changes to the package and labeling of a medical device to be reflected in the information system,
- Renewal of registration,
- Uploading information about imported medical devices,
- Other procedures related to entering information into the system.
The guide issued by the agency provides step-by-step instructions to be followed by the medical device manufacturers and other parties involved when uploading details about their products in the information system, which constitutes a national register of medical devices and manufacturers and allows its users to access important data in a structured way. The document describes in detail the way the information could be uploaded, viewed, and amended. The information system also contains the particular dates the appropriate certificates have were uploaded, allowing users to track their validity.
Information About Medical Device Manufacturers
First, the user guide describes information stored within the system regarding medical device manufacturers allowed to market their products in Bosnia and Herzegovina. According to the document, such information includes:
- Name of the manufacturer,
- Contact details of the responsible person,
- List of certificates,
- Information about manufacturing facilities.
The appropriate section also displays all documents associated with the particular manufacturer, namely:
- EC certificates,
- Design evaluation,
- Authorization letters,
- Free Sale Certificates,
- Declaration of Conformity.
Each of the documents has such mandatory requisites as the number, the date it has was issued, and also an indication of validity term or expiration date. It is also possible to associate the document with the particular notified body or other authority which has granted it. If there is no such authority in the dropdown list, the manufacturer shall add it.
Any and all certificates uploaded to the information system would be subject to mandatory validation. The applicant can see the document’s current status – the ones that still need to be submitted to validation will be marked in red, while those already submitted – in green, respectively.
The authority emphasizes that the manufacturer shall ensure the validity of certificates uploaded and replace them with new ones when necessary. The certificate should be replaced if its validity period will expire soon, or there were some changes to be reflected. The certificate will be replaced with the new one upon validation by the authority. After this, all information about the certificate will be updated automatically. It is important to mention that any changes to certificates that have been already uploaded should be approved by the authority as well.
In order to be able to indicate the place where a medical device was manufactured, the applicant shall upload information about manufacturing facilities. Apart from its physical address, it is also necessary to provide an ISO certificate. According to the user guide, it should be either ISO 9001 or ISO 13485. This field is mandatory, so it would be impossible to proceed further without providing such a certificate. The complete set of information regarding the manufacturing site also contains its contact details, including phone number and email address. It is also important to mention that the information system will also display the main details on the ISO certificate, including the last validation date, the name of a person who conducted the evaluation, and the validity period.
According to the present user guide, it is important to delete or amend the document which is under review or is connected to other entries.
If the applicant manufactures only Class I (general or in vitro diagnostic medical devices), which are deemed to be low-risk products according to the national legislation and thus could be placed on the market under the simplified procedure, it will be sufficient to upload only permission and free sale certificate. In all other cases, a CE certificate is required.
Information About Medical Devices
Besides the details about medical device manufacturers and manufacturing facilities, the information register contains information about medical devices allowed to be marketed and used in Bosnia and Herzegovina. In this context, the following options are available:
- Initial registration,
- Renewal (the initial period of registration is 5 years, and later it should be renewed),
- Addition (applies in case of changes to the packaging of the device or its size), or
- Modification (significant changes to the medical device itself).
At the very first step of the application process, the applicant shall choose the framework to be applied, namely:
- New Regulations (Medical Devices Regulation 2017/745, In Vitro Diagnostic Medical Devices Regulation 2017/746), or
- Old Directives (93/42, 90/385, 98/79).
Then the manufacturer shall indicate the class of the medical device in question under the national risk-based classification. As mentioned, the regulatory requirements for low-risk medical devices are less strict than for the others. An additional indication is required in the case of sterile products, medical devices with measuring functions, and multiple-use medical devices.
If the medical device is manufactured by a foreign manufacturer, the details about the manufacturer and its local representative should be provided separately. In such a case, it will also be necessary to provide the appropriate authorization letter.
When submitting its request, the applicant shall indicate its status: a local manufacturer holding the appropriate establishment license, an authorized representative of a foreign manufacturer, or a distributor duly registered under the appropriate framework.
In case of the modification request, the applicant shall choose the particular type of modification depending on the information subject to changes; this includes changes to the expiry date, storing conditions, or other changes.
According to the applicable regulatory requirements, the entity responsible for a medical device shall duly notify the authority in case of any changes to:
- Name or address of the manufacturer,
- Name or address of the registration certificate holder,
- Registration certificate holder itself,
- Name of the medical device,
- Medical device manufacturer,
- Manufacturing facility (change, removal, or addition of a new one),
- Examination standards and procedures applied for assessment of final products,
- Labeling or internal packaging,
- Design, shape, or packaging,
- Class of the medical device,
- Expiry date,
- Storing conditions,
- Other important elements (instructions for use, EC certificate, or catalog number).
Each new request may contain only medical devices assigned to one category.
In summary, the user guide published by the regulating authority describes the way an entity responsible for a medical device shall use the country’s information system for medical devices. The scope of the document covers the most important aspects related to adding new entries and making changes to existing ones.
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