Government Decree No. 342 / 2000 Coll.
Government regulations laying down medical devices which may endanger human health
Valid
Regulation
Effective from 27.09.2000
Text versions:
27.09.2000
342
GOVERNMENT REGULATION
of 30 August 2000
determining medical devices which may endanger human health
The Government orders pursuant to § 17 (1) of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws:
(1) Medical devices which may endanger human health, even if they are used without the supervision of, or intended to be used by, a doctor, a diagnosis by a doctor, or treatment according to instructions and supervision by a doctor, or are frequently used to a significant extent contrary to the intended purpose of their use, shall be considered to be:
(a) intrauterine body;
(b) an epidermal layer of pig skin for use as a biological dressing;
(c) hemodialysis concentrates;
(d) CPAP REM breathing medium,
(e) respiratory medical devices; and
(f) medical devices containing active substances subject to medical prescription (1) except where the medical device and medicinal product constitute a single integral product intended exclusively for use in this combination and not for repeated use.
(2) The procedure for prescribing medical devices is not affected by this Regulation. (2)
This Regulation shall enter into force on the day of its publication.
Prime Minister:
Ing. Zeman v. r.
Minister for Health:
Prof. MUDr. Fisher, CSc.
1) Article 48 (1) of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws, as amended by Act No. 149 / 2000 Coll., Act No. 153 / 2000 Coll. and Act No. 258 / 2000 Coll.
2) Decree No. 61 / 1990 Coll., on the Management of Medical needs, as amended by Decree No. 427 / 1992 Coll. and Act No. 79 / 1997 Coll.
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Regulation Information
| Citation | Decree of the Government No. 342 / 2000 Coll. |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 27.09.2000 |
|---|---|
| Effective from | 27.09.2000 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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