Malaysia MDA Publishes Draft Guidance on Notification of Custom-made Medical Devices
Malaysia’s MDA published draft guidance that provides a notification process for manufacturers of custom-made medical products when seeking Malaysian market access.
MDCG Issues New Guidance on MDR, IVDR Authorized Representative Requirements
Europe’s Medical Device Coordination Group (MDCG) has issued guidance on the responsibilities of authorized representatives.
Health Canada Issues Final Guidance on Clinical Evidence Requirements for Medical Devices
Health Canada finalized guidance on clinical evidence requirements for medical devices.
Indian Regulators Add to List of Medical Device Testing Laboratories
India CDSCO adds three more organizations to list of Medical Device Testing Laboratories( MDTLs)
Taiwan’s MOHW Issues Draft Revision of UDI Requirements; Draft Amendment of the Charge Standards of Administrative Fees
Taiwan’s MOHW has issued a draft revision of UDI requirements and a draft amendment of the charge standards of administrative fees for medical devices.
US FDA Updates Guidance on Identifying and Responding to Deficiencies
The US FDA has revised its guidance document to update the considerations on identifying and responding to deficiencies in premarket submissions.
US FDA Rules on Definitions of Device; Issues Revised Form for Reporting Adverse Events
US FDA issued revised guidance on definitions of device and counterfeit device. FDA also issued a revised MedWatch Form 3500A for adverse event reporting
ISO 14971 Risk Management Training for Medical Device Companies
Get trained on medical device risk management and QMS requirements with our fixed fee ISO 14971 course, including group training and eQMS demo opportunities.
South Korea Medical Device Classification
Emergo can assist you with determining South Korean medical device classification before beginning the MFDS regulatory requirement process.
Swiss Regulators Set to Recognize US FDA-cleared or Approved Medical Devices
New laws will enable manufacturers to leverage their FDA registrations for Swiss market access