This course seeks to provide a basic understanding of the regulatory landscape in Singapore. It covers key areas such as product classification, risk classification, product grouping and registration pathways. It also includes information on dealer licensing and a quick introduction to Health Sciences Authority (HSA) MEDICS system. There will also be tips on product registration, potential job roles and other requirements.
Certificate Courses

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS). It is an essential standard for medical device development companies. Besides being a common regulatory requirement, this standard, when adhered to, provides a Quality Management framework that supports quality products and processes.
Certificate Courses

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies. You can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations. Furthermore, you can begin preparing your relevant set of documents for immediate implementation of your SOPs.
Certificate Courses

The European Medical Device regulatory framework is undergoing a major change. Medical Device Directive (MDD) is being replaced by the Medical Device Regulation (MDR). This course helps the participants to understand what the new MDR entails and focusses on the important timelines within which the changes should happen.
Certificate Courses

This certificate course equips participants with a fundamental understanding of Medtech & Regulatory Affairs, backed by real-world practical examples. It is designed for regulatory practitioners, non-regulatory staff who collaborate with the regulatory team, or individuals considering a switch to the regulatory sector. Participants will learn the definition and classification of medical devices, global and regional regulatory environments, requirements in Asian countries, and key challenges and solutions in medical device regulations.
Certificate Courses

Introduction of medical device mainland China commercialization, factors to be considered from feasibility study, company and location setup, product development, to registration testing, clinical trial and new market development. In addition, medtech registration Green channel and other possible expedite options will also be covered.
Specialised Topics

A 30 mins video showing you the clinical trial approval process, local ethics committee approval, import & expert licence requirement, pharmacovigilance requirement and tips to make it smoother or quicker. Sharing by experts from OCT Clinical.
Specialised Topics

A MedTech Career sharing by experts in the industry, headhunter, academic with case studies. Anyone who wants to join the MedTech field will find this session helpful.
Introductory Topics

This two-part MedTech distributor webinar focusses on giving a clear understanding of how distributors select what product they want to distribute and invest in and the important role they play in the distribution.
Introductory Topics

Traditional & complementary medicines have been widely and increasingly used in both developed and developing countries, however it is not highly regulated and gaps exist between healthcare providers and National & Institutional efforts for integration. This course serves as an introduction to traditional & complementary medicines and its regulatory challenges designed for those who are interested to learn more about this industry.
Specialised Topics

The Asia Regulatory Professionals Association is collaborating with communications expert Wisse Kommunikatie (Worldcom PR Group) and language translation expert (MediqTrans) to establish a Crisis Management Alliance to share good practices on how to better manage this critical area.
Specialised Topics