News & Articles

This is a rather short article to share about the definition and published list of borderline medical device that might be supportive for your regulatory intelligence exercise. A borderline medical device might have some features of a medical device which is to diagnose ,treat or prevent a symptoms or diseases  and possibly  contain  agent or […]

Fueled by a consumer base eager to try out new, up-and-coming products from around the world, Singapore’s cosmetics and personal care industry has experienced remarkable growth in recent years. However, this surge has also caused the demand for quality to rise, with more customers expecting better efficacy and product safety. This increases the challenge that […]

Chinese Proprietary Medicines(中成药产品)  refers to finished medicinal  product, such as a capsule or tablet, and contains one or more active ingredients from any plant, animal or mineral, or any combination of sources. All the active ingredients must be documented for use in traditional Chinese medicine. Prior to importation and distribution of CPM in Singapore, CPM […]

Cell, tissue, gene therapy product (CTGTP) are health products intended for use in humans for a therapeutic, preventive, palliative or diagnostic purpose. CTGTP can contain any of the following and achieves its primary intended action by pharmacological, immunological, physiological, metabolic or physical means. CTGTP products are divided into 2 classes namely: Class 1 CTGTP product […]

Cosmetic products are substances or mixtures intended for application to the external parts of the body, such as the skin, hair, nails, lips and teeth, for purposes including cleansing, perfuming, protecting or enhancing appearance. In Singapore, cosmetic products are regulated by the Health Sciences Authority and are subject to a mandatory cosmetic product notification prior […]

At present, health supplements in Singapore are not subject to pre-market approval prior to importation. While notification may be performed on a voluntary basis, companies often misinterpret this as an absence of regulatory requirements. In practice, this perception can be misleading. Companies importing health supplements remain fully responsible for ensuring that their products comply with […]