Sat, Jun 19

|

Mexico City

On-site Course Registration of Medical Devices

At the end of the course, the attendee will be able to identify the regulatory process for granting the sanitary registration of medical devices in Mexico in accordance with current national regulations.

The possibility of registering has been closed
See other events
On-site Course Registration of Medical Devices

Horario y ubicación

Jun 19, 2021, 9:00 AM – 3:00 PM CDT

Mexico City, Viad. Río de la Piedad 260, Col. Magdalena Mixhuca, Venustiano Carranza, 15860 Mexico City, CDMX, Mexico

Acerca del evento

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

-------------------------------------------------- -------

cost

$ 2 000.00 (PER PERSON) Taxes Included

-------------------------------------------------- -------

 

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.

Compartir este evento