Medical


Greetings to all and Happy Spring!!


We welcome April with great energy looking forward to the warm weather and the flowers soon to adorn our fields.


This month we bring Medical Regulatory updates from Latin American Regulators. There has been a lot of activity that we need to share with you.


We also invite you to our webinar this coming week where we will be reviewing how wearable devices are classified in the different countries. Mexico has announced changes this year which are already impacting Smartwatches, and more changes to come with the publication of new regulation NOM-241-SSA1-2021 to be fully in effect in June 2023.


Our team mission and commitment to you is increasing your worldwide compliance success.



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April :

Wearable Devices and COVID-19 Impact on Latin America Sanitary Regulations

The accelerating proliferation of Wearable Devices with integrated health functions is driving new regulatory requirements in Latin America.

In this session our experts will review the radio and sanitary regulatory requirements for wearable devices and explain the impact that COVID-19 has had on regulatoy Sanitary Registrations.

The discussion will include an update on the current state of COVID 19 as many countries are starting to return to normal operations.

Our experts will cover Argentina, Brazil, Chile, Ecuador, Colombia, Costa Rica, Dominican Republic, Panama, Peru and Mexico.

Our goal is to support your market access planning and keep you updated on the latest regulatory updates.

 Join us and stay compliant!!


PLEASE JOIN US, AND STAY COMPLIANT !!

Date: April 7th, 2022 at 11:00 am PST

REGISTER NOW!

Upcoming Events

ISCT 2022. 

 May 4th-5th, 2022

Global society of clinicians, regulators, technologists and industry partners whose aim is to translate cellular therapy into safe and effective therapies to improve patients' lives. ISCT organises an annual meeting and offers a unique collaboration between academia, regulatory bodies and industry partners in cell therapy translation.

BioProcess International

September 27th-30th, 2022

Boston Convention and Exhibition Center
The largest bioprocessing event bringing the science, technologies and partners needed to accelerate promising biologics towards commercial success.

2022 ISPE Annual Meeting & Expo

Otober 30th - November 2nd, 2022

This signature event draws pharmaceutical and biopharmaceutical professionals at all levels of the industry from young professionals to the most senior executives in drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies. The conference offers a large exhibition hall offering the latest technologies and services for the pharmaceutical industry.

Americas Medical Regulatory
News

MEXICO

March 30, 2022
MEXICO – NOM-241-SSA1-2021 published COFEPRIS providing new guidelines for Medical Devices - Smartwatches now regulated.

Read  More...


CHILE

March 16, 2022
CHILE – The Chilean Public Health Institute, begins to receive sanitary registration applications for portable automatic external defibrillators.


Read  More...


MEXICO

March 14, 2022
MEXICO - Modifications in the extension processes for Sanitary supplies and Medical equipment. 


Read  More...


BRAZIL

March 2, 2022
BRAZIL - ANVISA Publishes the RDC No. 606 regarding Certification of Good Manufacturing Practices.

Read More...


USA

February 25, 2022
USA: FDA classification of the electrocardiograph software for over-the counter use - February, 2022.


Read More...


USA


COLOMBIA

February 18, 2022
INVIMA - DECISION 833 activates a surveillance mechanism for product labeling for Hygienic and Cosmetic Products.


Read More...


COLOMBIA

February 18, 2022
INVIMA Files New Guide for Certification or Recertification for Medical Devices.


Read More...


Asia

Medical Regulatory
News

MALAYSIA

March 9, 2022
MALAYSIA: MDA bans online sale of unregistered optical devices and contact lenses.


Read More...

Americas

Medical

Regulatory
News

MEXICO

March 30, 2022

MEXICO – NOM-241-SSA1-2021 published COFEPRIS providing new guidelines for Medical Devices - Smartwatches now regulated.


Read More...


CHILE

March 16, 2022

CHILE – The Chilean Public Health Institute, begins to receive sanitary registration applications for portable automatic external defibrillators.


Read More...


MEXICO

March 14, 2022

MEXICO - Modifications in the extension processes for Sanitary supplies and Medical equipment.

Read More...


BRAZIL

March 2, 2022

BRAZIL - ANVISA Publishes the RDC No. 606 regarding Certification of Good Manufacturing Practices .



Read  More...


USA

February 25, 2022

USA: FDA classification of the electrocardiograph software for over-the counter use - February, 2022.


Read More...


USA


COLOMBIA


COLOMBIA