Registration of Medical Devices for Sale in Singapore
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Registration of Medical Devices for Sale in Singapore

The Singapore Regulatory and Registration Procedures for the Sale of Medical Devices
New
0.0 (0 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
1 student enrolled
Created by Nealda Yusof
Last updated 9/2017
English
English [Auto-generated]
Current price: $15 Original price: $60 Discount: 75% off
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Includes:
  • 33 mins on-demand video
  • 3 Articles
  • 10 Supplemental Resources
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion

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What Will I Learn?
  • Legislation and principles underpinning the Singapore regulatory framework
  • Statutory responsibilities of the Health Sciences Authority
  • Brief overview on the medical device risk classification
  • Product registration and condition for exemption
  • The product registration application route
  • Submission of technical documentation and dossier template requirements
  • Criteria to qualify for shorter evaluation routes
  • Dealer establishment registration
  • Postmarket vigilance requirements
  • Requirements for handling adverse events
  • Adverse event reporting timeline
View Curriculum
Requirements
  • Basic knowledge in medical device regulations
Description

Course Description

This course is one part of an online learning series on the Singapore medical device regulations. Singapore is an important economic hub in South-East Asia. Its healthcare delivery system is technology-driven and one of the most advanced in the world. In Asia, Singapore is regarded as a leading nation in spearheading a comprehensive regulatory framework governing medical devices. The Health Sciences Authority (HSA), its regulatory body, is an active member and contributor of the ASEAN Harmonisation Working Party (AHWP) for medical devices and the International Medical Device Regulators Forum (IMDRF). In Singapore, medical devices are controlled using harmonised regulatory policies and risk-based principles.

This course covers topics on the regulatory procedures required for the import and sale of medical devices in Singapore. This includes:

  1. An overview of the regulatory framework
  2. The product authorisation and review
  3. Dealer license registration
  4. Postmarket vigilance and mandatory reporting

Why is this course essential to take?

This course is essential for organisations who plan to place medical devices on the Singapore market. It enables an understanding of the organisation's regulatory responsibilities in registering its products and sponsors. This includes grasping the concept for medical device risk classification and the corresponding technical documentation requirements. The HSA also lays out routes for shorter regulatory evaluation for product owners who meet certain approval criteria. Guidance documents can be downloaded from this course for additional information.

Who is the target audience?
  • Medical Device Startups
  • Regulatory Affairs Professionals
  • Technical Sales and Marketing Professionals
  • Business Development Professional
  • Investors
  • Consultants
Compare to Other Medical Device Development Courses
Curriculum For This Course
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Lessons
5 Lectures 33:25

This lecture provides a quick introduction to the medical device regulatory framework in Singapore

Preview 04:00

In this lecture, we dive into the principles used to regulate medical devices in Singapore e.g. statutory responsibilities and the medical device risk classification.

Preview 06:36

Quiz 1: Regulatory Framework
3 questions

This lecture discusses the regulatory approval pathways for the different medical device risk classification. It provides criteria on how to qualify for shorter evaluation routes.

Authorisation Routes
13:25

Quiz 2: Authorisation Routes
6 questions

This lecture teaches how Singapore monitors and controls business establishments that deal in medical devices e.g. manufacture, importation and sale.

Dealer License
04:01

Quiz 3: Dealer License
3 questions

This lecture provides insights on the postmarket obligations of medical device establishments, including complaints handling and mandatory adverse incident reporting.

Postmarket Reporting
05:23

Quiz 4: Postmarket Reporting
5 questions
About the Instructor
Nealda Yusof
4.1 Average rating
45 Reviews
158 Students
2 Courses
Medical Device Coach and Trainer

A former CEO of a successful CRO startup in Singapore from 2003 to 2008, Dr. Nealda Yusof’s experience in the medical technology sector spans 16 years. Specialising mainly in medical devices, she has been actively involved in the entire product lifecycle process ranging from research, regulatory, testing & validation, quality assurance, risk and crisis management, compliance and commercialisation. She advised multinational heavyweights in the healthcare sector such as GlaxoSmithKline and Edwards Lifesciences, and worked in close collaboration with NAMSA and Charles River. In 2012, she was appointed to an advisory role to the CEO in a renal care group and tasked to oversee teams in the United Kingdom, Germany, Egypt and Turkey. Her work involves setting guidelines for successful business operations, product development, R&D, subsidiary communications, project management, ERP system and organisational development strategies. Dr. Yusof uses her background in both science and law to provide a holistic combination of technical, regulatory and liability perspectives.

Dr. Nealda Yusof obtained her Doctor of Philosophy (Ph.D.) in Material Science from the National University of Singapore, and a Bachelor of Law (LLB) with Honours from the University of Birmingham in the United Kingdom.