US Medical Device Regulations via the FDA

Regulatory Agency

The State Institute for Drug Control (SÚKL).regulates the medical devices in Czech Republic.

Medical Device Definition

Medical Device: means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.
The investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state.
Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations.

And which does not achieve its principal intended action by pharmacological, immunological, or metabolic means in or on the human body, but which may be assisted in its function by such means.

Active Device: means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances, or other elements between an active device and the patient without any significant change shall not be deemed to be active devices. Software shall also be deemed to be an active device.

Medical Device Classification System

Classification	Risk Level	Examples
l ls (sterile) lm (measuring) Ir (reusable)	Low Risk	Wheelchairs, stethoscopes, Spectacles
IIa	Medium Risk	Dental fillings, Surgical Clams, Tracheotomy tubes
IIb	Medium High Risk	Lung ventilators, Bone fixation plate, Condoms
III	High Risk	Pacemakers, Heart valves, Implanted cerebral, simulators

Regulatory Approval Process

Classification	Approval Procedure
I Is (sterile) Im (measuring) Ir (reusable)	Medical devices in the lowest risk class (Class I) are not required to be registered in the Czech Republic by the State Institute for Drug Control (SÚKL).
IIa IIb III	Classify the device according to the EU Medical Devices Regulation (MDR 2017/745). Appoint an Authorized Representative in the Czech Republic (or elsewhere in the EU) If the manufacturer is an EU-based entity, they can directly submit the device registration with State Institute for Drug Control (SÚKL) The distributor 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. submit the medical device notification required documentation via the Registry of Medical Devices (RZPRO) electronic portal The authority will verify the submitted information, and once confirmed, the device will be registered and approved for sale in the Czech market for 5 years.

Classification

Approval Procedure

I
Is (sterile)
Im (measuring)
Ir (reusable)

Medical devices in the lowest risk class (Class I) are not required to be registered in the Czech Republic by the State Institute for Drug Control (SÚKL).

IIa
IIb
III

Classify the device according to the EU Medical Devices Regulation (MDR 2017/745).
Appoint an Authorized Representative in the Czech Republic (or elsewhere in the EU)
If the manufacturer is an EU-based entity, they can directly submit the device registration with State Institute for Drug Control (SÚKL)
The distributor 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.
submit the medical device notification required documentation via the Registry of Medical Devices (RZPRO) electronic portal
The authority will verify the submitted information, and once confirmed, the device will be registered and approved for sale in the Czech market for 5 years.

Additional Information

Approval Timeline	Not specified by the agency
License validity period	5 years
Fees	The Medical Device notification in the Czech Republic is free of charge

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