G/TBT/N/CHE/229  
27 March  2018 
(18-1896) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  French  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : SWITZERLAND  
If applicable, name of local government involved (Articles  3.2 and 7.2):   
2. Agency responsible : Office fédéral de la santé publique , OFSP (Federal Office of Public 
Health)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Secrétariat d'Etat à l'économie , SECO (State Secretariat for Economic Affairs)  
Holzikofenweg 36, 3003 Berne  
tbt@seco.admin.ch , http://www.seco.admin.ch/   
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) : (i) Medicines 
including products of chemical or biological origin which are intended to have a medical 
effect on human or animal organisms, or which are presented as such, and which serve 
namely to diagnose, prevent or treat diseases, injuries or disabilities ; blood and blood 
products are considered as medicines (relevant tariff items : 3002, 3003, 3004).  
(ii) Medical devices including products such as instruments, apparatus, equipment, in -vitro 
diagnostics, software, implants, reagents, material and other articles or substances which 
are intended for medical use, or which are presented as such, and which do not achieve 
their principal action through medicines (relevant tariff items : 3006, 9001.3000, 
9001.4000, 9001.500 0, 9003, 9004, 9018 -9021).  
5. Title, number of pages and language(s) of the notified document : Projet d'acte 
modificateur de la loi fédérale sur les médicaments et les dispositifs médicaux (Loi sur les 
produits thérapeutiques, LPTh) (Draft Act amending th e Federal Law on Medicinal Products 
and Medical Devices (Law on Therapeutic Products, LPTh)) (12 pages, available in French, 
German and Italian)  
6. Description of content : The European Union has adopted two new regulations : one on 
medical devices, and the  other on in -vitro diagnostic devices . It aims to improve the 
quality and safety of medical devices, to harmonize the implementation of legislation in the 
EU, and thereby increase the safety of patients . In the context of the partial revision of the 
Law on  Therapeutic Products, the legislation relating to the regulation of medical devices 
has been redrafted and adapted to the new EU legislation . The partially revised law 
establishes, inter alia, the obligations for economic operators and the adapted 
require ments for medical devices, the conformity assessment procedure, and the 
registration and identification of products that must be brought into line with the 
corresponding EU provisions (the regulation on medical devices and the regulation on in -
vitro diagno stic devices) . In parallel, the legislation in force regarding medical devices has 
been reviewed in terms of existing measures, and adapted where necessary.  G/TBT/N/CHE/229  
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable : The amendmen t of the Law on Therapeutic Products will improve the safety 
and quality of medical devices in Switzerland . Furthermore, it is essential to maintain 
equivalence between Swiss and European legislation to avoid technical barriers to trade 
between the two par ties and to continue to guarantee supply, and ensure the safety of 
patients . Switzerland and the EU are working together to effectively and efficiently monitor 
the market for medical devices and ensure that patients benefit from greater security and 
increa sed transparency regarding information on medical devices.  
8. Relevant documents:  
Projet d'acte modificateur de la loi fédérale sur les médicaments et les dispositifs médicaux 
(Loi sur les produits thérapeutiques, LPTh)  (Draft Act amending the Federal Law on 
Medicinal Products and Medical Device s (Law on Therapeutic Products, LPTh)):  
 German: https://www.admin.ch/ch/d/gg/pc/documents/2941/HMG_de.pdf  
 French: https://www.admin.ch/ch/f/gg/pc/documents/2941/LPTh_fr.pdf  
 Italian: https://www.admin.ch/ch/i/gg/pc/documents/2941/LATer_it.pdf  
La loi fédérale sur les médicaments et les dispositifs médicaux actuellement en vigueur (Loi 
sur les produits thérapeutiques, LPTh)  (Federal Law on Medicinal Products and Medical 
Devices currently  in force (Law on Therapeuti c Products, LPTh)):  
 German: https://www.admin.ch/opc/de/classified -
compilation/20002716/index.html  
 French: https://www.admin.ch/opc/fr/classified -compilation/20002716/index.html  
 Italian: https://www.admin.ch/opc/it/classified -compilation/20002716/index.html   
9. Proposed date of adoption : 21 November 2 018 
Proposed date of entry into force : 27 May 2 020  
10. Final date for comments : 60 days from the date of notification.  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body: