Singapore University of Social Sciences

Healthcare Standards and Regulations

Healthcare Standards and Regulations (BME217)


The course aims to provide students with a general understanding of a healthcare regulation as it exists in Singapore with relevant emphasis on regulation that pertains to biomedical engineering. There will also be a brief overview of relevant foreign examples such as FDA, CE etc. Students would also be given an introduction into international health standards and accreditation systems.

Level: 2
Credit Units: 5
Presentation Pattern: Every July
E-Learning: BLENDED - Learning is done MAINLY online using interactive study materials in Canvas. Students receive guidance and support from online instructors via discussion forums and emails. This is supplemented with SOME face-to-face sessions. If the course has an exam component, this will be administered on-campus.


  • International Pharmaceutical and Drug Development
  • Regulation of Western Medicine in Singapore
  • Goods and Manufacturing Practices (GMP)
  • Validation for Drugs
  • International Regulation for Medical Devices
  • Classification of Medical Devices
  • Healthcare standards in hospitals
  • Joint Commission International (JCI) certifications
  • Risk management
  • Business continuity planning
  • Emerging issues in Healthcare Standards and Regulations (Part 1)
  • Emerging issues in Healthcare Standards and Regulations (Part 2)

Learning Outcome

  • Discuss the role and operations of regulatory bodies in Singapore and worldwide
  • Examine the role of legislation, regulations, principles of cGMP and guidance in healthcare industry
  • Apply knowledge of the common healthcare standards required in the industry
  • Explain the use of a framework on what is required for licensing of a medical devices
  • Design a checklist on audit of healthcare standards in the hospital
  • Develop a risk assessment and business continuity project at workplace
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