Title              Regulatory Affairs for Beginners 

Modality  Classroom course

Date            Saturday, June 19, 2021

Duration      6 hours

Speaker       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. Regulatory Agent and Legal Framework

3. New agreements and regulations derived from the contingency

4. Regulatory Process to Market a DM in Mexico

  -Registration of establishment and sanitary manager

     -Certificate of Good Manufacturing Practices

     -Health Register

     -Permissions

5. Medical Device Dossier

     -Legal- Administrative Information

    - Request Form / Payment of Rights / Accreditation of Legal Representative

    - Notice of Operation and Health Responsible

    - Label or counter label projects

    - Certification of free sale / Certificate of Good Manufacturing Practices of the establishment / Letter of Representation

    - Declaration of endorsement by the Health Responsible  

    - General information

    - Instructions for use, insert or operating manual or leaflet

  -Quality and safety information

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

    - Declaration of the qualitative formula

    - Raw materials / Laboratory tests /  Manufacturing process information / Packaging information

    - Analytical certificate or product certificate / Stability studies / Biocompatibility tests

    - Clinical studies

6. Attention to the procedure: Check-List, Format, Homoclaves.

7. Approval times

8. Causes for not granting the Sanitary Registry

9. Conclusions

GRADES

• The deadline to finalize your payment will be 1 week prior to the event.
• DO NOT REGISTER IF YOU ARE NOT SURE TO TAKE THE 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.
• This course will take place with the recommended sanitary measures.