1. MEDICAL DEVICES
DRUGS
ECUADOR
REGULATION

2. MEDICAL DEVICES REGULATION
LEGAL BASE
DEFINITION
MEICAL DEVICES
Regular Questions
MEDICAL DEVICES REGULATION
DEVICES CLASIFICATION
REQUIREMENTS
DEVICES REACTIVES
SYSTEM
VUE
PROCESS:
INSCRIPTION
RE-INSCRIPTION
MODIFICATION
Web Page

3. Medical Devices Instruccionals
LEGAL BASE
Health Law
Ministerial Agreement Regulation and Control Health Medical Dental Devices.
Medical Devices Instruccionals

4. MEDICAL DEVICES
DEFINITION
They are articles, instruments, apparatus, appliances or mechanical inventions, including its components, parts or accessories manufactured, sold or recommended for use in diagnosis, curative or palliative treatment, prevention of a disease, disorder or abnormal physical state or its symptoms to replace or modify the anatomy or a physiological process or control. Includes amalgams, varnishes, sealants and similar dental products and are as follows ....

5. MEDICAL DEVICES CLASIFICATION
ACCORDING TO USE
ACCORDING TO RISK

6. MEDICAL DEVICES CLASIFICATION
Codificación de la UMDNS (Nomenclatura Universal de Dispositivos Médicos del Instituto ECRI)
Global Harmonization Task Force

7. Luces de curación dental.
Classification
Electrocardiógrafos
Termómetros electrónicos
Equipo de succión
Luces de curación dental.
ACTIVE
ACCORDING TO USE
Luces de curación dental.
Adhesivos de uso tópico
Apósitos
Jeringas sin aguja
Vendas y gasas absorventes
collares cervicales, vendajes, medias elásticas
Guantes de examen
INVASIVE
NON INVASIVE
Prótesis dentales fijas
Agujas de sutura
Agujas para jeringas
Lancetas
Guantes quirúrgicos
Prótesis de mama

8. Classification ACCORDING TO RISK LOW RISK MODERATE RISK HIGH RISK
CRITICAL RISK

9. CERTIFICATES OF HEALTH RECORDS
SYSTEM TO ISSUE
CERTIFICATES OF HEALTH RECORDS
FOR EXTERNAL USERS
VUE
Ecuadorian Single Window for Foreign Trade (VUE)
FOR INTERNAL USERS
SIVC
Informatics' System, Sanitary Surveillance and Control (SIVC)
It is an electronic tool through which all users of customs services and, in general, all foreign trade operators will present the requirements, procedures and documents required for conducting foreign trade operations.
WHAT IS?
The overall objective of VUE system is to optimize and integrate foreign trade processes.
HEALTH RECORD CAN BE VALIDATED ONLINE
PRINCIPAL OBJETIVE?

10. REGISTRATION OF HEALTH RECORD
PROCESS FLOW CHART
REGISTRATION OF HEALTH RECORD
EXTERNAL USER SEND THE APLICATION TO ARCSA
TECHNICAL AND LEGAL REPRESENT
ARCSA
REVIEW AND REMARKS
PAYMENT MADE
TECHNICAL AND LEGAL REVIEW
HEALTH RECORD APPROVED.
EXTERNAL USER FIX THE OBSERVATION ISSUED
EXTERNAL USER FIX THE OBSERVATION ISSUED
904,34

11. MODIFICATION OF HEALTH RECORD
PROCESS FLOW CHART
MODIFICATION OF HEALTH RECORD
EXTERNAL USER SEND THE APLICATION TO ARCSA
TOKEN , TECHNICAL AND LEGAL REPRESENT
ARCSA
REVIEW AND REMARKS
PAYMENT MADE
TECHNICAL AND LEGAL REVIEW
HEALTH RECORD APPROVED.
EXTERNAL USER FIX THE OBSERVATION ISSUED
EXTERNAL USER FIX THE OBSERVATION ISSUED
90,34

12. RE-REGISTRATION OF HEALTH RECORD
FLUJOGRAMA DEL PROCESO
EXTERNAL USER SEND THE APLICATION TO ARCSA
TOKEN, TECHNICAL AND LEGAL REPRESENT
ARCSA
REVIEW AND REMARKS
HEALTH RECORD APPROVED.
EXTERNAL USER FIX THE OBSERVATION ISSUED

13. REGISTRATION OF HEALTH RECORD REQUIREMENTS MEDICAL DEVICE
Finished Product Specifications
Product Authorization Holder to request medical record Ecuador.
Quality Certificate or Certificate of Analysis
Description of Use
Certificate of Sterility
Scientific Literature Product
Certificate of Stability
Original Product Tags
Interpretation of the Lot
Formats interim Tags, Inserts for use in Spanish.
Certificate of Free Sale
Certificate of GMP or:
ISO 9001 (RISK 1)
ISO 13485(RISK>1)
NOTE: The applicant must submit a separate application for medical devices belonging to the same class, group, risk, trademark, owner and manufacturer (single plant).

14. REQUISITOS/INSTRUCTIVOS
Página web:

15. DRUG REGULATION

16. DRUG REGULATIONS
LEGAL BASE
REQUIERMENTS

17. Ministerial Agreement 586.
LEGAL BASE
Health Law
Ministerial Agreement 586.
Drug Regulation.
Satatus: Valid, 15/03/2014
Drugs
Instruccionals

18. REGISTRATION OF HEALTH RECORD
REQUIREMENTS
DRUG REGULATION
1. Current certificate of pharmaceutical product marketed. 2. Authorization of the owner or duly authenticated Product power. 3. Format internal and external product labels to market in Ecuador. 4. Memorandum addressed to the user written in Castilian language. 5. Certificate of Good Manufacturing Practices in force and duly authenticated. 6. Specifications of finished product quality. 7. Interpretation of batch code 8. Justification of the composition formula 9. Description of the manufacturing process of the drug 10. Analytical methodology of the finished product.

19. REGISTRATION OF HEALTH RECORD
REQUIREMENTS
DRUG REGULATION
11. Internal and external of how the drug is marketed in the country of origin Original tags. 12. Specifications of quality raw materials. 13. Stability Study Product 14. Description of the nature of the primary container and / or secondary 15. Documentation of safety and efficacy of the finished product. 16. A copy of the authorization of the owner of the product for the use of technical documentation. 17. Working pharmacological and toxicological nature (for new drugs). 18. Justification for the pharmaceutical equivalence (for alternate manufacturers). 19. Studies of equivalence in vivo / in vitro bioequivalence (where applicable).

20. Very thanks
GRACIAS