Decree No. 303 / 2003 Coll.
Decree amending Decree No. 350 / 2000 Coll., regulating the sale of medical devices
Valid
Order
Effective from 01.03.2004
Text versions:
01.03.2004
18.09.2003
303
DECLARATION
of 3 September 2003
amending Decree No. 350 / 2000 Coll., regulating the sale of medical devices
The Ministry of Health provides pursuant to § 18 (2) of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws, as amended by Act No. 130 / 2003 Coll.:
Decree No. 350 / 2000 Coll., regulating the sale of medical devices, is amended as follows:
1. in Paragraph 1 (2), including footnotes (1a) and (1b):
"(2) Medical devices:
(a) classification classes I, 1a) except:
1. compression grips and hosiery medical devices from class II above,
2. orthogonal with special construction,
3rd prosthesis,
where an authorised person does not participate in conformity assessment;
(b) medical thermometers;
(c) tonometers;
(d) sterile bandages; and
(e) condoms
they may purchase, store and sell persons who have acquired trade authorisation for the purchase, storage and sale of medical devices under special legislation (1b) (hereinafter referred to as "medical devices vendors').
1a) Government Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Decree No. 336 / 2001 Coll.
1b) Paragraph 18 (1) of Act No. 455 / 1991 Coll., on Business Business (Trade Act), as amended by Act No. 130 / 2003 Coll. '.
2. In Paragraph 2 (1), the words "in vitro 'shall be added at the end of the text in point (k).
3. In Article 2 (2), the words "in vitro 'shall be added at the end of the text in point (g).
4. in Paragraph 2 (3), including footnote (6a):
"(3) The medical devices referred to in § 1 (2) of this Decree may be sold to consumers by medical devices sellers. 6a)
6a) § 2 (1) (a) of Act No. 634 / 1992 Coll., on Consumer Protection. '.
5. In the introductory sentence of Article 3 (1), the words "persons who have acquired the licensed trade, 5) 'are replaced by the words" sellers of medical devices'.
6. in Article 3 (1) (a), the words "before sunlight" shall be inserted after the words "substances."
7. In Article 3 (1) (b), the words "having regard to the period of application or technical condition 'shall be inserted after the word" sales'.
8. In Article 3 (2), the dot is replaced by a semicolon and the words, including footnote 6b, are added "these medical devices shall be treated in accordance with a specific legislation. (b)
6b) Act No. 185 / 2001Coll., on waste, as amended by Act No. 477 / 2001 Coll., Act No. 76 / 2002 Coll., Act No. 275 / 2002 Coll. and Act No. 320 / 2002 Coll. '.
(9) footnote 7 shall read:
"7) Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 205 / 2002 Coll. and Act No. 226 / 2003 Coll. Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws, as amended by Act No. 130 / 2003 Coll. and Act No. 274 / 2003 Coll. Act No. 102 / 2001 Coll., on general product safety and amending certain laws (Act on general product safety), as amended by Act No. 146 / 2002 Coll. Decree No. 181 / 2001 Coll., as amended by Decree No. 336 / 2001 Coll. Government Decree No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices, as amended by Government Decree No. 337 / 2001 Coll. Government Decree No. 286 / 2001 Coll., laying down technical requirements for in vitro diagnostic medical devices. '
(10) footnote 8 shall read:
8) Act No. 64 / 1986 Coll., on Czech Trade Inspection, as amended by Act No. 240 / 1992 Coll., Act No. 22 / 1997 Coll., Act No. 110 / 1997 Coll., Act No. 189 / 1990 Coll., Act No. 71 / 2000 Coll., Act No. 145 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 321 / 2001 Coll., Act No. 205 / 2002 Coll., Act No. 309 / 2002 Coll. and Act No. 226 / 2003 Coll. '
11. the Annex to the Order is deleted.
This Decree shall take effect on 1 March 2004.
Minister:
Dr. Součková v. r.
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Regulation Information
| Citation | Decree No. 303 / 2003 Coll., amending Decree No. 350 / 2000 Coll., regulating the sale of medical devices |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.09.2003 |
|---|---|
| Effective from | 01.03.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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