1. PAHO/WHO Collaborating Centre Regulation of Medical Devices
4th WHO Global Forum on Medical Devices “Increasing access to medical devices”
13-15 Dec 2018, Visakhapatnam, Andhra Pradesh, India
PAHO/WHO Collaborating Centre
Regulation of Medical Devices
Eng. Dulce María Martínez Pereira
Assistant Manager
Medical Devices
CECMED

2. Experiences in the application of strategies for
REGULATORY PROGRAM FOR MEDICAL DEVICES
systemic and harmonic character
flexible to our realities
taking international tendencies into account
and scientific & technical collaboration
interrelationships and responsibilities of stakeholders
communication and constant technical improvement both regulators and staff related to medical devices
impact in health

3. approval of Sanitary Register
certifications that authorize the operation of factories
requirements of the import and export of medical devices
regulatory audits by the authority
improvement of the role of post-market surveillance with scope to the use of medical devices in health care services
MARKET IMPACT

4. Collaborating Centre PAHO/WHO
for the Regulation on Health Technology (CUB-26)
1rst designation:
re-designation:
Strengthening the regulatory capacity of medical devices in the Region of the Americas
joint strategies
consensus
constant comunication
shared results
Regional WG for MD
NRAs CC
PANDRH

5. TOR
Strengthening of the Health Authorities Network for the regulation of medical devices, facilitating effective and timely exchange of regulatory information between countries in the region
To improve the capacity in the region on regulation of medical devices through educational activities, development and dissemination of resource materials regarding medical devices regulatory issues
To provide technical assistance to support the strengthening of the quality, safety and efficacy of medical devices at the global, regional and national levels
To participate in collaborative studies and to conduct regulatory research according to WHO priorities
To collaborate on the preparation and execution of training and educational activities on quality assurance and radiation protection of radiation medicine services (diagnostic imaging, radiotherapy and nuclear medicine services)

6. INVIMA/CECMED - PANDRH project
Given lectures of the virtual course on regulation of medical devices (CECMED - two editions)
17 countries (Belize, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Spain, Guatemala, Honduras, México, Panamá, Paraguay, Perú, Dominican Republic, Uruguay, Venezuela)
obtained academic results above 98%
trained the staff of the regional regulatory authorities represented by 128 students
INVIMA/CECMED - PANDRH project
“ Strengthening of regulatory capacity on medical devices in the Region of the Americas

7. Completed the mapping of opportunities and needs for capacity building on regulation of medical devices in the region
sixteen countries surveyed
replies received from ten countries: Brazil, Mexico, Colombia, Panama, El Salvador, Chile, Ecuador, Dominican Republic, Paraguay and Cuba
elaborated report
identified opportunities and training needs in regulatory issues of medical devices in the region

8. Program of Exchange of Reports of Adverse Events in the Region of the Americas (REDMA Program / NCAR mirror group)
discussed the strategy with countries of the region and established the bases of the REDMA program
automated system through the internet proved in pilot phase (10 NRAs registered) - total functionality of the web system, with high user satisfaction, recognizing it as a safe and effective
migration of the REDMA web system database to the PAHO server
repository of medical devices adverse events reports

9. The REDMA system was developed to allow the exchange of reports of adverse events or incidents in medical devices among the NRA of the Region of the Americas.
This represents a proactive communication system that implies the possibility of making decisions based on security information quickly
Although the data exchange process using REDMA is not open to the public and will be restricted among the participating NRAs of the system, regulatory actions officially published by the ARNs are accessible.
REDMA was developed by the PAHO/WHO Collaborating Center in Cuba
Further information please contact

10. Regional mapping - instrument of basic indicators
To evaluate the current situation of the Regulation of medical devices in the countries of the Region of the Americas
Applied instrument to 18 countries of the Region
11 modules with 47 basic indicators
Results will be posted on the Medical Devices Observatory within PRAIS
To develop Regional Regulatory Profile
INVIMA/CECMED - PANDRH project
“ Strengthening of regulatory capacity on medical devices in the Region of the Americas

11. Good Regulatory Practices
PANAMA
DOMINICAN
REPUBLIC
MEXICO
EL SALVADOR
ECUADOR
CHILE
PERU
BELIZE
ARGENTINA
URUGUAY
BOLIVIA
HONDURAS
PARAGUAY
BRAZIL
CANADA
COLOMBIA
CUBA
NICARAGUA
Module I
Human Resources
Module II
Good Regulatory Practices
Module III
National Regulatory System
Module IV
Import Controls
Module V
Marketing Authorization (Registration)
Module VI
Licensing
Module VII
Postmarketing Surveillance
Module VIII
Regulatory Inspections
Module IX
Testing Laboratories
Module X
Clinical Trials
Module XI
In Vitro Diagnostics (IVD)

12. All participating countries have establish:
Preliminary results
All participating countries have establish:
Few countries have:
sanitary registration or other authorization of the ARN for the commercialization of the medical devices in the country
the adoption of an official medical device nomenclature system
scope, functions, attributions and responsibilities of the ARN
requirements that require compliance with ISO 13485
responsibilities of the manufacturer and / or its authorized representative, importers, distributors, suppliers; with the post-marketing surveillance
inspection of foreign establishments engaged in the manufacture of medical devices
inspections of national establishments
an official control laboratory for medical devices

13. Regulatory strengthening in the Region
Goals
Regulatory strengthening in the Region
Build a regional folder for capacitation on medical devices regulation
Translate editions of the virtual course on regulation of medical devices to English
Create a Community of Practice in the PRAIS Platform for members of the REDMA program
Official start of the integral operation of the REDMA Program - Launch expected for 15 Jan 2019
To point to a regional regulatory perfil for medical devices