G/TBT/N/PAN/109  
29 June 2020 
(20-4490) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : PANAMA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Salud  (Ministry of Health)  
Dirección Nacional de Dispositivos Médicos  (National Directorate for Medical Devices)  
Calle Culebra, Ancón Antiguo Hospital Gorgas, detrás del Instituto Oncológico  
Panamá, Panama  
Tel.: (+507) 512 -9100, Ext. 1280  
Email: rvbatista@minsa.gob.pa  
Website: http://www.minsa.gob.pa  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or auth ority designated to handle comments 
regarding the notification shall be indicated if different from above:  
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 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) : Chapter 90, 
headings : 90.02; 90.03; 90.04; 90.10; 90.11; 90.12; 90.18; 90.19; 90.20; 90.21 and 
90.22.  
Chapter 94, heading 94.02 : Medical, surgical or dental furniture . Other headings : 
94.02.10 ; 94.03.10 ; 25.20; 35.02; 34.07 and 30.06.  
5. Title, number of pages and language(s) of the notified document : Decreto Ejecutivo 
No. 490 de 4 de octubre de 2019, que reglamenta la Ley 90 de 26 de diciembre de 2017 
sobre dispositivos médicos y productos afines, conforme fue modificada por la ley 92 de 12 
de septiembre de 2019 (Executive Decree No. 490 of 4 October 2 019 laying down 
regulations for Law No. 90 of 2 6 December 2 017 on medical devices and related products, 
as am ended by Law No. 92 of 1 2 September 2 019) (27 pages, in Spanish)  
6. Description of content : The notified Executive Decree lays down regulations for Law No. 
90 of 2017 , amended by Law No. 92 of 2019, which governs all aspects relating to the 
manufacturing,  packaging, importation, exportation, re -exportation, information, 
advertising, labelling, distribution, marketing, storage, use and final disposal of medical 
devices and related products in Panama, including in vitro medical devices.  
In addition, it establishes the National Directorate for Medical Devices, which will be the 
authority responsible for regulating and monitoring medical devices and related products in 
Panama.  
It also regulates all aspects relating to operating licen ces; requirements for issuing, 
renewing, updating and correcting technical criteria certificates ; the monitoring  of medical 
devices ; and fees and penalties.  G/TBT/N/PAN/109  
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable : The objective of L aw No. 90 of 2017, as amended by Law No. 92 of 2019 and 
its regulation s (Executive Decree No. 490 of 2019) , is the protection of human health.  
8. Relevant documents:  
• Ley 90 de 26 de diciembre de 2017  
• Ley 92 de 12 de septiembre de 2019  
• Decreto Ejecutivo No. 490 de 4 de octubre de 2019  
9. Proposed date of adoption : Immediately  
Proposed date of entry into force : Immediately  
10. Final date for comments : None 
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio de Salud  
Dirección Nacional de Dispositivos Médicos  
Calle Culebra, Ancón Antiguo Hospital Gorgas, detrás del Instituto Oncológico  
Panamá, Panama  
Tel.: (+507) 512 -9100, Ext. 1280  
Email: rvbatista@minsa.gob.pa  
Website: http://www.minsa.gob.pa  
http://www.minsa.gob.pa/sites/default/files/normatividad/decreto_ejecutivo_490_de_202
0.pdf 
https://www.gacetaoficial.gob.pa/pdfTemp/28875_A/GacetaNo_28875a_20191004.pdf