WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/520
27 October 2000
(00-4497)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   CZECH REPUBLIC
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Medical devices
5. Title, number of pages and language(s) of the notified document:   An Amendment to
Government Order No. 180/1998 Coll. on T echnical Requirements for Medical Devices
(approx. 80 pages, in Czech)
6. Description of content:   This amendment concerns conditions for certification, clinical
investigation and authorisation of medical devices. It lays down provisions concerning
notified bodies, criteria of their appointment and reticence.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Compatibility with Directives 93/42/EEC and 98/79/EC
8. Relevant documents:   Government order No. 180/1998 Coll. on Technical Requirements
for Medical Devices
9. Proposed date of adoption:
Proposed date of entry into force:  1 January 2001
10. Final date for comments:   30 November 2000
11. Texts available from:  National enquiry point [X] or address, e-mail and telefax
number of the other body:   wto.tbt@biskup.unmz.cz