Medical Device Regulatory Requirements for Singapore: An Overview

Singapore is expected to institute new requirements for medical device registration within the next few years. Currently, very few medical devices are subject to mandatory product registration in Singapore. Among those products that do require registration are radiation-emitting equipment, contact lenses and contact lens care products, HIV test kits, and condoms. For those devices that are not subject to registration, generally all that is required is evidence of approval in the United States, Europe, or Japan – for example, a “Certificate to Foreign Government” from the U.S. FDA or a Certificate of Free Sale.

While new medical device registration regulations are developed, Singapore’s Centre for Medical Device Regulation (CMDR) is developing a system of voluntary measures and procedures to monitor medical devices that are imported into, supplied within, or exported from Singapore. At first, only high-risk, Class III devices (Singapore uses the European Union’s classification rules for this purpose) will be targeted. Manufacturers (or authorized representatives) will be asked to provide detailed information with regard to a product’s quality, safety, and efficacy. Those products that pass a review by CMDR will be included in the Singapore Medical Device Register, a computer database of information about medical devices in use in Singapore. Eventually, listing in the Register will become a requirement for all medical devices, and hospitals and clinics will be restricted to purchasing only those devices that have been listed.