The document outlines the key points related to the Maltese regulatory requirements in the sphere of medical devices. In particular, the guidance addresses the matters associated with the fees payable by the parties responsible for medical devices intended to be marketed and used in the country.
The Malta Medicines Authority (MMA), a Maltese regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the fees in relation to medical devices. The document provides an overview of the regulatory requirements based on the existing framework and also provides additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. In particular, the authority states that the present document is intended to assist applicants in identifying the correct fees to accompany applications/activities related to medical devices. The MMA also mentions that the respective proof of payment should be provided by the applicant as a confirmation of completion of its payment obligations set forth by the existing legislation.
As further explained by the authority, the guidance covers the matters to the fees associated with:
- Distributors/importers of medical devices and/or in-vitro medical devices (covering also vigilance activities);
- Manufacturers of medical devices and/or in-vitro medical devices;
- Designation and extension of the scope of a notified body;
- Authorized representatives;
- Audits and inspections of activities by the economic operators;
- Applying for Certificate of Free Sale;
- Applying for device registration, placing a medical device on the European Market through Malta;
- Search function of medical devices database.
Apart from the aspects outlined hereabove, the guidance also addresses the matters associated with the initial and additional applications related to medical devices intended to be used in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 (the novel coronavirus) and public health emergency associated thereto.
Terms and Definitions
First of all, the document provides definitions of the most important terms and concepts used in the context of medical devices and fees associated thereto. The terms described in the guidance include, inter alia, the following ones: “Authorised Representative”, “Conformity Assessment Body”, “Designated premises”, “Distributor”, “Economic Operator”, “Health Care Professional”, “Importer”, “In Vitro Diagnostic medical device”, “Manufacturer”, “Medical Device”, “Notified Body”, and “Point-of-Care Covid-19 Test or Device for Self-Testing for Covid-19”. Some of the definitions provided in the guidance are the same as set forth by the respective Regulations (EU) 2017/745 (Medical Devices Regulation, MDR) and 2017/746 (In Vitro Diagnostic devices directive, IVDR).
Apart from the above, the document also describes such concepts as “National Derogations” and “Union-wide derogations”. With respect to the first concept, the authority mentions that in accordance with the existing regulatory framework, national regulatory agencies are entitled to, on a duly justified request, to authorize the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of public health or patient safety or health. The second concept describes the situations when the European Commission, an EU-wide regulatory agency responsible for medical devices, is entitled to introduce a national derogation for a limited period of time to the territory of the Union. The MMA additionally emphasizes that such actions could take place in extraordinary cases when it is vitally important to ensure the availability of specific medical devices to healthcare professionals and patients. In particular, this allows to avoid potential shortages in the supply of critical devices.
The guidance starts with information about the fees payable by the entities distributing medical devices within the territory of Malta. The regulatory actions addressed in the guidance include, inter alia, the following:
- Initial Registration of Distributor / Importer (subject to renewal on an annual basis);
- Notification fee per device (the same approach applies – annual renewal);
- Change in Organisation Registration Application details;
- Amending Notification of Medical Device (Revise);
- Application Form for Medical Device Registered Person (MDRP) (should also be subject to renewal on an annual basis).
The authority also mentions that the application for withdrawal of the submission does not require any fee to be paid.
As additional notes, the authority highlights the following:
- The applicants may choose a fast-track procedure giving their submission priority. In such a case, the fees payable will increase twice.
- The notification fee is payable for each of the medical devices intended to be supplied in the country.
- If the distribution of medical devices is performed by its manufacturer (the same entity), the abovementioned fees should apply as well.
- For MDRP applications, a fast-track option is also available.
In the same way, the document describes the fees payable in the context of:
- Manufacturing general and in vitro diagnostic medical devices;
- Regulatory procedures associated with the designation of notified bodies;
- Authorized representatives and the activities they undertake;
- Audits and inspections to be carried out in the context of post-market surveillance activities;
- Other activities and additional documents the parties responsible for medical devices may order.
In summary, the present MMA guidance provides an overview of the current regulatory requirements with respect to fees associated with medical devices. The document defines the most important terms and concepts used and also outlines the approach to be followed by the parties involved in order to ensure compliance with the respective regulatory requirements, including the way the fees should be calculated and paid.
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