Decree of the Ministry of Health No. 350 / 2000 Coll.
Decree of the Ministry of Health regulating the sale of medical devices
Valid
Order
Effective from 09.10.2000
Text versions:
01.03.2004
09.10.2000
350
DECLARATION
Ministry of Health,
of 19 September 2000
regulating the sale of medical devices
According to § 18 (1) of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws:
Regulation on the sale of medical devices
(1) Medical devices may sell and provide technical information on them and, where appropriate, examine their functions as pharmacies and other medical devices designated for this purpose by specific legislation.1)
(2) Medical devices:
(a) classification classes I, 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
may purchase, store and sell persons who have obtained a trade licence for the purchase, storage and sale of medical devices under a special legislation (hereinafter referred to as "medical devices vendors').
(1) Self-service and automatic machines must not be sold
(a) mammary epiteses,
(b) prostheses,
(c) orthopaedic appliances,
(d) hearing aids;
(e) diopters,
(f) lenses and contact lenses,
(g) active implantable medical devices;
(h) anaesthetic medical devices;
(i) dental medical devices;
(j) electromechanical medical devices;
(k) in vitro diagnostic medical devices;
(l) inactive implantable medical devices; and
(m) medical devices using nuclear energy and ionising radiation.
(2) Shipments and computer networks must not be sold
(a) hearing aids;
(b) diopters,
(c) lenses and contact lenses;
(d) active implantable medical devices;
(e) anaesthetic medical devices,
(f) dental medical devices,
(g) in vitro diagnostic medical devices;
(h) inactive implantable medical devices; and
(i) medical devices using nuclear energy and ionising radiation.
(3) The medical devices referred to in § 1 (2) of this Decree may be sold to consumers by medical devices sellers. 6a)
Basic requirements for storage and sale of medical devices
(1) The medical devices which can be sold by the medical devices sellers pursuant to Article 1 (2) must be:
(a) stored separately from other products in dry, well ventilated rooms in such a way as to protect them from contamination with other stored substances, from sunlight and from the introduction of animals; the temperature at the place of storage shall not exceed 15 ° C to 25 ° C unless otherwise specified on the packaging of such devices, in the instructions or other information provided by the manufacturers; and
(b) checked that there is no reason for their withdrawal from sale in respect of the period of application or technical condition.
(2) Medical devices referred to in Paragraph 1 (2) which have been excluded from sale must be stored separately from medical devices which may be sold; such medical devices shall be handled in accordance with specific legislation. (b)
(1) Only medical devices which have been placed on the market in accordance with specific legislation may be sold. 7)
(2) Medical devices may not be sold or otherwise distributed if:
(a) their period of application has expired;
(b) the integrity of their original packaging has been infringed or, where appropriate, no or no legible marking on their packaging is available;
(c) the conditions laid down by the manufacturer under which these devices must be stored have changed;
(d) so decided by the Czech Trade Inspection Office, 8); or
(e) the instructions for use in the Czech language are missing.
(3) When selling a medical device, the buyer shall be advised by the seller of the need to study the instructions for the use of the medical device sold or, where appropriate, other instructions from the manufacturer before using it.
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Prof. MUDr. Fisher, CSc.
1) Sections 20 (1) and 37 of Act No. 20 / 1966 Coll., on the Care of People, as amended. § 3 (1) of Act No. 160 / 1992 Coll., on Health Care in NSAs.
2) Decree of the Government No. 342 / 2000 Coll., establishing medical devices which may endanger human health.
3) Article 2 (1) of Act No. 79 / 1997 Coll., on Medicines and on Amendments and Additions to Certain Related Acts.
4) Article 6 of Decree No. 180 / 1998 Coll., laying down technical requirements for medical devices.
5) Annex No. 3, Group 315 of Act No. 455 / 1991 Coll., on Business Business (Trade Act), as amended by Act No. 123 / 2000 Coll.
6) Decree No. 77 / 1981 Coll., on health professionals and other health professionals.
6a) § 2 (1) (a) of Act No. 634 / 1992 Coll., on Consumer Protection.
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.
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.
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.
9) § 2 (2) (f) of Act No. 123 / 2000 Coll.
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Regulation Information
| Citation | Decree of the Ministry of Health No. 350 / 2000 Coll., regulating the sale of medical devices |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.10.2000 |
|---|---|
| Effective from | 09.10.2000 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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