IVD Medical Device Clinical Performance Evaluation Studies
In Europe, certain in vitro diagnostic (IVD) devices must undergo clinical performance (CP) evaluation studies conducted in accordance with current regulations in order to obtain CE Marking.
Taiwan Agent Representation for Medical Device Companies
Taiwan Agent support for medical device manufacturers with no office in Taiwan.
TFDA - Taiwan Food and Drug Administration
Within the Ministry of Health and Welfare, the Taiwan Food and Drug Administration (TFDA) was established in 2010 to oversee food, drug, and medical device safety and quality.
Peru Registration Holder (PRH) In-country Representation
Emergo offers Peru registration holder (PRH) representation for medical device companies with no local office in Peru.
2021 Medical Device Industry Outlook
Read the results of our 2021 Medical Device Industry Outlook Survey, based on responses from 1600 professionals.
ANVISA - Brazil National Health Surveillance Agency
The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical
Hong Kong Medical Device Regulatory Strategy Report
Let Emergo assist you in evaluating the Hong Kong medical device regulatory framework as it applies to your device(s).
South Korea Medical Device Vigilance Reporting
ANSWERED ON THIS PAGE:
When are vigilance reports required in South Korea?
What is considered a severe adverse event by Korean authorities?
What are the steps in the Korean vigilance process?
Singapore Registrant Representation for Medical Device Companies
ANSWERED ON THIS PAGE:
What are the responsibilities of a Singapore Registrant?
What are the requirements for a Singapore Registrant?
What is the difference between a Registrant and a Licensed Importer?
New Zealand Sponsor Representation for Medical Device Companies
Medical device manufacturers and importers seeking to break into the New Zealand market must first select an in-country sponsor.