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.
COURSE OUTLINE Due to the complexity of today’s medical products, routine end-product testing alone is often not sufficient to assure product quality for several reasons. Some end-product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end-product testing does not reveal variations…
COURSE OUTLINE ISO 13485:2016 an international standard designed to orient quality management systems toward the design, development, production, and installation of medical devices and related services. Medical Devices are products designed to cope with disease, treat injuries, investigate and augment human functions and they also are made up of a host of other apparatuses and…
SIC can provide practical and efficient SOPs for:
ISO 13485:2016
MDSAP
Thai GMP for Medical Devices, Good Distribution Practice for Medical Devices (GDPMD)
Medical Device Directive (93/42/EEC) – CE Marking
In-Vitro Diagnostic Medical Device Directive (98/79/EC) – CE Marking
EU Medical Device Regulation (MDR 2017/745)
US Quality System Regulation (21 CFR Part 820)
Japan Quality Management System (J-QMS Ordinance)
Creation of US Pre-Market Notification (510k)
Creation of Technical Documentation according to New EU Medical Device Regulation
Consolidation and/or interpretation/translation of Common Submission Dossier Template (CSDT) according to ASEAN MDD (AMDD) for Importer
Creation of Common Submission Dossier Template (CSDT) for manufacturer according to ASEAN MDD (AMDD)
Creation of Technical Documentation according to European Medical Device Directive (93/42/EEC)
Contact/Liaise with EU Authorized Representative on behalf of Product Owner/Manufacturer
Import & Export Requirements
Labeling & Advertising Review US Medical Device Reporting, EU Adverse Event Reporting
Device classification according to ASEAN MDD, EU MDD/MDR, US FDA
Product modification strategies and management
US FDA Warning Letter Resolution