RESTRICTED

GENERAL AGREEMENT TBT/Notif.95.25

11 May 1995

ON TARIFFS AND TRADE Special Distribution

(95-1235)

Committee on Technical Barriers to Trade

 

NOTIFICATION

The following notification is being circulated in accordance with Article 10.4.

1. Party to Agreement notifying: SWITZERLAND

2. Agency responsible: Federal Office for Public Health

3. Notified under Article 2.5.2 [X], 2.6.1 [ ], 7.3.2 [ ], 7.4.1 [ ], other:

4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.

ICS numbers may be provided in addition, where applicable):

Medical devices as defined in EC Directive 93/42/EEC without IVD

5. Title and number of pages of the notified document: Medical Device Ordinance

6. Description of content: Transposition of EC Directive 93/42/EEC into national legislation. CE-market-products will be allowed on the Swiss-market without any restrictions.

7. Objective and rationale: Switzerland had so far no comprehensive regulation on this matter. With the implementation of this Directive in EEC countries, Switzerland harmonizes its legislation so as to guarantee the protection of public health.

8. Relevant documents: Federal Law concerning the safety of technical appliances and equipment

9. Proposed date of adoption and entry into force: 1 October 1995

10. Final date for comments: 26 June 1995

11. Texts available from: National enquiry point [X] or address and telefax number of other body: