SWITZERLAND: IN-VITRO DIAGNOSTIC PRODUCTS The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif. 96.13. 1. Member to Agreement notifying: SWITZERLAND. If applicable, name of local government involved (Articles 3.2 and 7.2): 2. Agency responsible: Federal Office of Public Health. 3. Notified under Article 2.9.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): In-vitro diagnostic products. 5. Title and number of pages of the notified document: Ordinance concerning In-Vitro Diagnostic Products. 6. Description of content: The Ordinance of 24 February 1993 concerning In-Vitro Diagnostics covers only those products for the detection of infectious diseases which use as their test principle an immunological reaction (the detection of an antigen or antibody). It stipulates for these products either a pre-marketing notification, or in the case of tests for the detection of HIV, Hepatitis B or Hepatitis C, a pre-marketing approval. Newly included in the Ordinance are all in-vitro diagnostics, e.g. tests for the detection of infectious agents which are based on methods other than immunological reactions (e.g. the Polymerise Chain Reaction), pregnancy tests, and tests for the determination of blood groups. A pre-marketing approval will be required for all tests designed for the detection of HIV, Hepatitis B and Hepatitis C; for all other tests, a pre-marketing notification will be required. 7. Objective and rationale: The Federal Resolution concerning the control of blood, blood products and transplants with an alteration of the Epidemic Law of 18 December 1970 (the parliamentary consultation is expected to be concluded in March 1996). The Resolution of the Federal Council of 9 November 1994 concerning the future Medicines Control Act. 8. Relevant documents: Revised Edict: the Ordinance of 24 February 1993 concerning In-Vitro Diagnostics. 9. Proposed date of adoption and entry into force: 1 July 1996. 10. Final date for comments: 25 March 1996. (040)

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