Title:           Dossier of Medical Devices

Modality   Classroom course

Date           Saturday  of October 2, 2021

Duration     6 hours

Schedule        09: 00-15: 00 hours

Speaker       QFB Azucena Justo Marcos

Campus               Hotel Holiday Inn Dalí Airport

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cost

$ 2,000.00 (PER PERSON) Taxes Included

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It includes

- Face-to-face course (Explanatory and applicative part)

- Printed material

- Ballpoint

- Continuous coffee service

- Light breakfast

- Diploma of participation issued by REGULATE

- Certificate DC-3 (Secretary of Labor and Social Welfare)

- Parking lot

   TEMARY 

1. Introduction

2. Dossier  Medical Device

- Application Form and Payment of Rights

- Accreditation of legal representative

- Notice of Operation and Health Responsible

- Label or counter label projects

- Free sale certification

- Certificate of Good Manufacturing Practices of the establishment

- Maquila agreement

- Representation letter

- Declaration of endorsement by the Health Responsible for

- General information

- Instructions for use, insert or operating manual or leaflet

- Composition, description, or diagram of the functional parts of the product

- Declaration of the qualitative formula per unit of measure, dose or percentage for formulated products

- Raw Materials

- Lab tests

-  Manufacturing process information

- Sterilization

- Packaging information

- Analytical certificate or product certificate

- Stability studies

- Biocompatibility tests

- Clinical studies

3. Attention of the procedure: Check-List, Format, Homoclaves.

4. Approval times

5. Causes for not granting the Sanitary Registry

6. Conclusions

GRADES

• The deadline to finalize your payment will be 24 hours before the course.
• DO NOT REGISTER IF YOU ARE NOT SURE TO TAKE THE ONLINE COURSE SINCE YOU WILL BE MAKING THE OPPORTUNITY FROM ANOTHER INTERESTED PERSON.
• At the end of your registration, our REGULATE team will send you a registration confirmation email and the payment information will be sent.