Health Products Act (Chapter 122D): Primary legislation governing medical devices in Singapore, establishing regulatory framework for health products including medical devices
Health Products (Medical Devices) Regulations 2010: Specific regulations detailing requirements for medical device registration, licensing, and compliance in Singapore
Health Products (Licensing of Retail Pharmacies) Regulations: Regulations governing the retail distribution and sale of medical devices through pharmacies
ISO 13485: International standard for medical devices quality management systems that must be considered in licensing agreements
Good Distribution Practice for Medical Devices (GDPMDS): Guidelines ensuring proper distribution practices for medical devices in Singapore
Patents Act (Chapter 221): Legislation protecting intellectual property rights related to medical device innovations and technology
Trade Marks Act (Chapter 332): Law governing trademark protection for medical device branding and intellectual property
Copyright Act (Chapter 63): Legislation protecting copyright aspects of medical device documentation, software, and related materials
Contract Law (Chapter 53): General contract law principles governing the formation and enforcement of license agreements in Singapore
Sale of Goods Act (Chapter 393): Law governing commercial transactions and sales aspects of medical devices
Competition Act (Chapter 50B): Legislation ensuring fair competition and preventing anti-competitive practices in medical device licensing
Personal Data Protection Act 2012 (PDPA): Law governing the collection, use, and disclosure of personal data in medical device operations
ASEAN Medical Device Directive (AMDD): Regional framework harmonizing medical device regulations across ASEAN member states
Consumer Protection (Fair Trading) Act: Legislation protecting consumer interests in medical device transactions and usage
GN-23: Guidance on Medical Device Software: HSA guidelines specific to software components of medical devices
Singapore Medical Device Registration (SMDR) guidelines: Regulatory guidelines for registering medical devices with the Health Sciences Authority
