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Czech Republic Medical Device Registration

Process of registration/notification of a medical device in the Czech Republic in general

Czech Republic as a part of EU followed directions regarding to medical devices in its own nation legislation. According to the Council Directive 93/42/EEC, the Czech Republic has issued the 268/2014 Coll. act on Medical Devices and on Amendments to Act No 634/2004 Coll., on Administrative Fees, As Amended, (hereinafter referred to as the “ACT”). According to Regulation (EU) 2017/745 of the European Parliament and of the Council (hereinafter referred to as the “MDR”) the Czech Republic has issued a new act at national level, the 89/2021 Coll., which is legally binding since 26th May 2021. Until EUDAMED will be fully functional, please follow next instructions.

Based on issued ACT, Section 26, Subsection 3, a person who intends to act as an importer, distributor, or a servicing person within the territory of the Czech Republic, must notify its operation of an importer, distributor, or a servicing person to the Institute prior to the commencement of this operation. Registration of a person is completed by the issue of a certificate of compliance with the notification duty. This obligation shall not apply to importers and distributors of risk class I medical devices and in vitro diagnostic medical devices which are not placed on list A or list B, and which are not medical devices intended for self-testing.

If there is an existing person who is registered as an importer or distributor and has duly notified medical devices, and you are going to replace this person, it is mandatory to first submit an application for remove all the medical devices notified by that person and then submit an application for remove the person himself. It is not allowed for both person (old and new importer/distributor) to perform here at the same time.

Further, according to Section 33, Subsection 1, Thedistributor or importer of a medical device shall be obliged to submit an application for notification of the medical device to the Institute no later than within 15 days of the date of its placement on the market or supply to the market in the Czech Republic. This obligation shall not be applicable to risk class I, custom-made medical devices and in vitro diagnostic medical devices which do not belong to list A or list B, and which are not medical devices intended for self-testing.

A person who makes medical device available on the market in the Czech Republic makes the registration and notification.

According to Section 33 of act no. 268/2014 Coll., an importer or distributor shall not be obliged to submit an application only for:

  • individually manufactured medical devices,
  • Medical devices of risk class I,
  • In vitro diagnostic medical devices that do not belong to List A or List B and are not self-testing medical devices.

The application for notification of a medical device supplied by a distributor or importer shall be filed electronically via the Registry of Medical Devices, on-line platform.

If you intend to act as an importer, distributor or a servicing person please, go to: http://www.sukl.eu/medical-devices/launch-of-the-new-registry-of-medical-devices (recommended to open in Google Chrome web browser) – „Request for access to the registry as RZPRO Notifier “. As soon as is obtained the access code, you will be able to notify your operation to the Institute. While the request will be confirmed, you shall be obliged to submit applications for notification of the medical devices. The access code is obtained within a few days.

The whole processcontains of 3 steps. First of all is mandatory to obtain the access code. Secondly, a company – the manufacturer, authorized representative, distributor or importer submit an application. While the application is confirmed by Institute, the company can submit application for a medical device.

Please see also: https://www.niszp.cz/en/registration-and-notification-registry-medical devices/manuals. There you can find manuals, which should help you when you are working with Registry of Medical Devices and our website National information system of medical devices.

Please see also: https://www.niszp.cz/index.php/en/registration-and-notification.

According to Section 34 of act no. 268/2014 Coll., Particulars of the application for notification of medical devices supplied by a distributor or importer,  the application must contain, only mandatory document attached, the current version of the instructions for use in the Czech language; such condition does not need to be fulfilled for risk class I or IIa medical devices, if the manufacturer has established that it is not necessary for the safe use of the medical device. In case you have chosen risk class IIa, select if the IFU has been issued by the manufacturer. If you select “yes “, make sure to attach the IFU. IFU is not required in MD risk class IIa, if the manufacturer has established that it is not necessary for its safe use.

According to Section 35 of act no. 268/2014 Coll., Notification of a medical device is completed by the coming legally into force of the decision on notification. No repeal may be filed from an Institute’s decision fully granting the application of the applicant. The Institute shall enter the medical device in the Registry of Medical Devices without unnecessary delay. By submitting the application for notification of medical device itself, it fulfils the final obligations imposed by the Act. In case of changes to the data mentioned in the notification, the manufacturer, authorised representative, distributor or importer shall be obliged to submit an application for change to the notification to the Institute in electronic format via the Registry of Medical Devices within 30 days. In case of a change of legal manufacturer, this fact must be reported immediately through a submit application for a change of medical device´s data with the attachment of current documents that reflect the change of the legal manufacturer, consequently its name and address.

A medical device notification shall be effective for the period of five years of the date of coming legally into force of the decision on notification.

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