There is an account for reimbursements for medical devices. Seven days to submit comments

  • On June 8, the Ministry of Health published a draft regulation from the Minister of Health on reimbursements for medical devices
  • The regulation has been published in connection with the Medical Devices Act, which has been in force since May 26
  • The amount of the fees [za zgłoszenie wyrobu medycznego i wydanie świadectwa wolnej sprzedaży – red.] takes into account the workload and the amount of costs incurred in processing applications or issuing advice – justifies the Ministry of Health
  • The reimbursements also apply to applications related to the clinical examination of a medical device
  • The draft regulation has been sent for public consultations and opinions, with a deadline of 7 days for comments, says the Ministry of Health

In which direction are preventive self-government programs going?  Rebroadcast of the debate

Clinical Trial Application, Certification, and Application Fee

On June 8, the draft regulation of the Minister of Health on reimbursements for medical devices was published. The proposed provisions constitute the implementation of the legal authorization contained in art. 73 of the law of 7 April 2022 on medical devices. The draft specifies the amount of the fees referred to in art. 72 seconds. 1 of the deed.

– The amount of the fees was set at a level comparable to the Regulation of the Minister of Health of 16 February 2016 on the amount of the fees for submitting notifications on products and the amount of the fees for submitting an application for a certificate of free sale ( Journal of Laws, item 202) and the Regulation of the Minister of Health of 17 February 2016 on templates for applications related to the clinical examination of a medical device or active implantable medical device and the amount of the fees for submitting these applications (Journal of Laws, item 208), based on the cost of conducting these activities – provided by the Ministry of Health.

The draft regulation has been sent for public consultations and opinions, with a deadline of seven days for comments. The shortening of the time limit for taking a position is related to the need for the draft regulation to enter into force as soon as possible.

As of May 26, 2022, there are no provisions constituting the legal basis for the collection of fees in cases related to clinical trials in connection with the repeal of the provisions of the Regulation of the Minister of Health of February 17, 2016 on models of applications related to the clinical trial of a medical device or active medical device for implant and the amount of the fees for the submission of such applications (Journal of Laws, item 208).

But paper orders for medical devices are a thing of the past?  The bill will be submitted to the Sejm

Senators ask about funding sources for medical pay rises.  Bromber: the distribution of the money is determined

The Regulation provides for a transitional provision

The amount of the reimbursements takes into account the workload and the amount of the costs incurred in connection with the processing of applications or the issuing of advice.

Paragraph 3 of the proposed regulation provides for a transitional provision under which, in the case of applications submitted and not examined before the date of entry into force of the proposed regulation, fees will be collected on the basis of the provisions in force on the date of submission of the application.

The Ministry of Health indicates that the purpose of this provision is an unequivocal conclusion that the existing provisions are only applied in the scope that relates only to reimbursements. In the remaining scope, the proceedings are conducted inter alia “in accordance with the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amendments to Directive 2001/83/EC , Regulation (EC) no. 178/2002 and Regulation (EC) no. 1223/2009 (…) – we read in the motivation of the draft.

Draft Regulation – available for download below the text.

The Minister of Health appoints the Initiatives Assessment Team.  He will deal with ICT systems

The National Congress of Physiotherapists divided the functions among the representatives.  We know the names

TO DOWNLOAD

Read more about:

Leave a Comment