MEDICAL DEVICES DRUGS ECUADOR REGULATION

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

Medical Devices Instruccionals LEGAL BASE Health Law Ministerial Agreement 205. Regulation and Control Health Medical Dental Devices. Medical Devices Instruccionals

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 ....

MEDICAL DEVICES CLASIFICATION ACCORDING TO USE ACCORDING TO RISK

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

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

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

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?

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

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

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

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).

REQUISITOS/INSTRUCTIVOS Página web: http://www.controlsanitario.gob.ec/

DRUG REGULATION

DRUG REGULATIONS LEGAL BASE REQUIERMENTS

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

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.

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).

Very thanks GRACIAS