Decree of the Ministry of Health No. 356 / 2001 Coll.
Decree of the Ministry of Health on the authorisation of exemptions from the technical requirements for the medical device for its use in the provision of health care and on the scope of published information on their authorisation
Valid
Order
Effective from 10.10.2001
Text versions:
10.10.2001
356
DECLARATION
Ministry of Health
of 21 September 2001
on the authorisation of exemptions from the technical requirements for the medical device for its use in the provision of health care and the scope of the published information on their authorisation
The Ministry of Health provides pursuant to § 7 paragraphs 2 and 5 of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws:
Forms of application for derogation
(1) The provider's application (1) submitted to the Ministry of Health in accordance with specific legislation (m2) contains:
(a) the business firm or the name and registered office of the provider, the name and surname of the statutory authority, the name and surname of the expert representative (3) and the identification number, where the application is made by a legal person, or the name, surname, permanent residence, identification number and place of provision of healthcare, where the application is made by the provider to which the natural person is a natural person; if the natural person is not a doctor, the application shall include the name and surname of the expert representative; 3)
(b) identification of the medical device (name, type or model, where applicable, classification class in accordance with specific legislation; 4)
(c) the relevant facts concerning the medical device
1. the intended purpose of use;
2. the therapeutic benefit of this device,
3. the degree of risk from its use for a particular sick natural person (the patient),
4. efficacy data,
5. Data on possible side effects,
6. safety data, 5) including information on technical regulations and standards used in the design and manufacture of this device available to the provider at the time of the application;
(d) identification details of the manufacturer or importer of the device (name, surname and permanent address of the natural person or business firm, or name and registered office of the legal person);
(e) age, gender and patient diagnosis code, (6) in the interest of which the application is made;
(f) medical justification for the necessity of using the medical device in that patient;
(g) an affidavit stating that the conditions for granting the exemption laid down in a separate legislation are fulfilled;
(h) an affidavit stating that the information provided in the request for exemption is true.
(2) The application referred to in paragraph 1 is accompanied by instructions on the use of the medical device.
Scope of the published exemption permit data
In the Bulletin of the Ministry of Health of the Czech Republic, the following information concerning the authorisation of the derogation is published:
(a) the company or name and registered office of the provider, if it is a legal person, or the name, surname and permanent address of the provider, if it is a natural person;
(b) identification of the medical device (name, type or model, where applicable, classification class in accordance with specific legislation, 4)
(c) the number of pieces of this medical device authorised for use in the provision of medical care;
(d) the method of placing on the market and the intended purpose of the use of that device;
(e) the age, gender and code of diagnosis (6) of the patient in whose interest the exemption was authorised,
(f) the duration of the exemption, where appropriate; and
(g) a statement that the conditions for granting the derogation laid down in the specific legislation.2 have been met;
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Prof. MUDr. Fisher, CSc.
1) § 3 (d) of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws.
2) § 7 (1) of Act No. 123 / 2000 Coll.
3) Article 9 (2) of Act No. 160 / 1992 Coll., on Health Care in Non-State Health Facilities.
4) Section 6 and Annex XVI to Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices.
5) Paragraph 3 (1) and (2) of Act No. 102 / 2001 Coll., on General Product Safety and on the Amendment of Certain Acts (Act on General Product Safety).
6) International Statistical Classification of Diseases and Associated Health Problems, as amended by the 10th Decenal Revision published in the Czech Statistical Office's measure of 5 May 1993 (reg.
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Regulation Information
| Citation | Decree of the Ministry of Health No. 356 / 2001 Coll., on the authorisation of exceptions to the technical requirements of the medical device for its use in the provision of health care and on the scope of published information on their authorisation |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.10.2001 |
|---|---|
| Effective from | 10.10.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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