In April 2001, Singapore’s Ministry of Health created the Health Sciences Authority (HSA). The HSA’s work covers a broad spectrum of scientific and professional functions. The HSA has signed Memoranda of Understanding (MOU) will various regulatory agencies around the world including the U.S. FDA, China FDA, Japan’s Ministry of Health, and Korea’s Ministry of Food and Drug Safety. In addition, the HSA collaborates with the World Health Organization on issues including blood transfusion, drug quality assurance, and food contamination monitoring. The HSA is divided into three main groups:
- The Health Products Regulation Group
- The Blood Services Group
- The Applied Services Group
The Health Products Regulation Group ensures that medical devices meet the required safety, quality, and efficacy standards. The Health Products Regulation Group is comprised of various divisions. These divisions are:
- Pre-marketing Division
- Post-marketing Division
- Audit and Licensing Branch
- Group Director’s Offices
The Medical Devices Branch is a subsection of the Pre-marketing Division. This branch regulates medical devices through a program of pre-market assessment, manufacturing controls, and post-market vigilance. The Medical Device Branch works in coordination with other branches and groups in order to carry out regulatory surveillance activities. These activities include investigating counterfeit devices, reporting adverse medical events, and general post-market monitoring.
Health Products Act
Implemented in November 2007, the Health Products Act regulates the manufacture, supply, packaging, and advertisement of all health products and medical devices in Singapore. The Act also empowers the HSA and grants it the authority to regulate and oversee medical devices. Manufacturers and importers should also note that Singapore has implemented other relevant Acts that affect the sale and distribution of medical devices. These Acts include the Private Hospitals and Medical Clinics Act, the Medical Registration Act, the Dental Registration Act, and the Radiation Protection Act.
Singapore’s Medical Device Register
The Singapore Medical Device Register (SMDR) is a database that contains a list of all medical devices that are currently being used on patients. The database is openly accessible by anyone and the public can search for devices by using the device name, product owner, identification number, or hospital.
Medical Device Classifications
In Singapore, medical devices are classified as either Class A, B, C, or D. Class A devices include simple, low risk tools such as tongue depressors while Class D are complex, high risk objects such as heart valves. Certain simple medical devices are exempt from regulatory controls if they present an extremely low level of risk to patients. Local testing and clinical studies are not required for medical device registration in Singapore.
The official HSA website has a number of helpful videos, tools, and documents that medical device companies can use to research Singapore medical device regulations and rules prior to registering their product.