4. Health products and medical device regulation

The regulation of health products comes under the purview of the Health Sciences Authority (HSA). Established as a Statutory Board under the Ministry of Health in 2001, HSA regulates the import, supply, or manufacture of a wide range of health products to ensure these products meet standards of safety, quality and efficacy for use in Singapore.

A risk-based approach is applied to calibrate the requirements and oversight imposed on the different categories of health products regulated:

1. Cell, tissue and gene therapy products

2. Complementary health products, including Chinese proprietary medicines, traditional medicines, health supplements and homeopathic medicines

3. Cosmetic products

4. Medicines (a.k.a. Therapeutic products)

5. Medical devices

Dealers intending to import, supply or manufacture health products are required to comply with the relevant prevailing laws such as the Health Products Act and Medicines Act alongside their subsidiary legislation, which may include requirements for product registration and dealer’s licensing.

Visit the Health Sciences Authority website for more information.