Importing Healthcare Products into Singapore Part 1: Introduction
The following is an overview of the regulatory regime that governs the import of healthcare products into Singapore. Note that this is neither a comprehensive compilation of requirements nor professional advice and this information should be used with that caution.
UNDERSTANDING THE REGULATORY BODIES
Health Sciences Authority (“HSA”), under the Ministry of Health, is the regulatory authority that administers the national regulatory frameworks for pharmaceuticals, complementary medicines, medical devices and other health products.
The Audits Branch and the Quality Assurance Office together form the Audit & Licensing Division (ALD). The Audits Branch audits and licenses pharmaceutical manufacturers, importers and wholesale dealers in accordance with International Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) standards respectively. GMP Audit & Licensing Unit, GDP Audit & Licensing Unit, Certification Unit and Overseas Audit Unit are the 4 units that reside under the Audits Branch.
The Pharmaceuticals and Biologics Branch (PBB) and Generics and Biosimilars Branch (GBB) are responsible for the registration of medicines and the continual review of approved medicinal products.
The Medical Device Branch of HSA issues guidelines for providing practical instructions related to medical devices for the industry.
The Complementary Health Products Branch oversees the regulation of Chinese Proprietary Medicines, other Traditional Medicines and Health Supplements. Chinese Proprietary Medicines (CPM) Unit administers regulatory control on CPM.
The Health Products Regulation Group of HSA must license all medicinal products imported or sold in Singapore. Health supplements can be imported and sold without a license from HAS and they are not subjected to pre-market approval regulations. However HSA has issued Guidelines for Health Supplements, and dealers are required to comply with these guidelines.
In line with the dynamic nature of the industry and its direct impact on public, Singapore is constantly revising and revamping its regulatory regime for healthcare products. In Singapore, medicinal and other health-related products are regulated under the following regulations:
- Medicines Act 1975 and its Regulations
- Medicines (Advertisement & Sales) Act
- Sales of Drugs Act and its Regulations
- Poisons Act and its Rule
Since November 1, 2007, the Singapore’s Health Sciences Authority has been implementing its Health Products Act of 2007. The Act comprehensively regulates all medical devices (including in vitro diagnostics) and cosmetic products.
For further information about importing specific healthcare products into Singapore, refer to the following guides:
Importing Western Medicine into Singapore
Importing Chinese Medicine into Singapore
Importing Medical Devices into Singapore