COURSE OUTLINE The FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) contain significant requirements in relation to design and development (design control). In many cases manufacturers have not satisfactorily established compliance with the regulation and standard and have received adverse inspections, including issuance of FDA Warning…
COURSE OUTLINE Practical workshops throughout the day are also provided in order to give you the opportunity to apply your skills how to implement risk analysis, risk evaluation, risk control, production and post-production activities and risk management review within your organization. This fully 2-day course is a highly interactive training that includes case study exercises,…
COURSE DESCRIPTION The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to meet regulatory and quality system requirements in multiple markets through a single audit. Current MDSAP members include Australia, Brazil, Canada, Japan, and the United States, and others are expected to join as the program matures. MDSAP has been required by Health…
COURSE DESCRIPTION Implementation of European Medical Device Regulations is the primary requirements while demonstrating the compliance to regulatory requirements while placing the products in European Market for the Medical Device manufacturers and to place CE marking on the products. The European Council Directives 90/385/EEC and 93/42/EEC has been revised to Regulation (EU) 2017/745. European Medical…
AGENDA DAY ONE Morning Session 09:00 – 09:30 Module 1: Overview of Worldwide Medical Device Regulations (United States, Japan, Canada, Europe, ASEAN) 09:30 – 10:30 Module 2: Overview of ASEAN Medical Device Directive (AMDD) Definition of medical device acc to AMDD and Thailand Medical Device Act Classification of Medical Devices 10:30…
COURSE OUTLINE This 1 day special training course “Corrective and Preventive Action” is intended as an introductory course to enable participants to have: Basic understanding of corrective and preventive action principles according to relevant regulatory standards Root cause analysis and corrective and preventive action taken Audit case studies to develop skill for identifying the root…
COURSE OUTLINE This 1 day special Quality System Regulation training program is intended as an introductory course to enable participants to have a basic understanding of US FDA Quality System Regulation, Quality System Inspection Techniques (QSIT) approach. Moreover, participants will be provided with tips for handling inspector during FDA inspection as well. Who Should Attend…
The Medical Device Coordination Group (MDCG) has issued a new guidance document MDCG 2021-1, Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional. The document seeks to provide clarification in a highly ambiguous scenario. Numerous references in Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) are related to EUDAMED and new and comprehensive registration procedures.
OVERVIEW
From 1 January 2021, the roles and responsibilities of those manufacturing and supplying medical devices and IVDs will change.
Manufacturers wishing to place a device on the UK market will first need to register with the MHRA.
Where a manufacturer is not established in the UK, in most cases it will need to designate a UK Responsible Person to register and act on its behalf.
Manufacturers will need to comply with relevant product marking and conformity assessment requirements for medical devices, including IVDs.
On February 15th the Thai FDA published significant new guidance governing the classification, common submission dossier template requirements, fee schedule and transition plan for medical device registration. This action enhances the harmonization of Thailand’s Medical Device Act B.E. 2562 (2019) (Issue 2) and the ASEAN Medical Devices Directive. The guidance is effective immediately for all new registrations and means a substantially increased regulatory burden for the vast majority of medical devices.