The Republic of Singapore, a densely populated country of five million people, has the third highest per capita income in the world. Consistently, Singapore ranks at the top of international lists profiling investment potential, ease of doing business, open economies, and best business environments. The government of Singapore has recently placed the development of the biotechnology sector as a top priority in the country’s fiscal plans, resulting in hundreds of millions of dollars in funding for that industry.

Since new regulations were introduced in 2010, registration in Singapore has become more complex.

THE GOOD NEWS:

The registration process for medical devices in Singapore is fairly similar to the EU, with a nearly identical classification system for devices.

THE BETTER NEWS:

If your device already carries approval from authorities in the USA, the EU, Canada, Japan, or Australia, you can cut your registration time in half.

The Health Sciences Authority in Singapore updated its regulations for medical devices in 2010, which increased the time of the registration process. According to our experience, the process can take as much as 30% longer than listed by the Health Sciences Authority. Without approval from the USA, EU, Canada, Japan, or Australia, registration for Class A (EU equivalent Class I) is as short as one month. As the risk increases, registration time increases from approximately four months to up to a year. However, with approval from the regulatory bodies of at least one of the countries listed above, registration time is reduced by 30-50%.

Certain Class B devices are eligible for immediate release on the market once they are registered in the database. However, devices that incorporate a medicinal product are subject to a review of between 220 and 310 days in length, depending on the type and nature of the product, regardless of prior certification. The longer turn-around-time is due to the joint evaluation of these devices by the Medical Device Branch and the Pharmaceuticals and Biologics Branch.

Registration in Singapore must be conducted through a local authorized representative. Devices are registered online through the The Singapore Medical Device Register (SMDR).

WHAT YOU NEED TO KNOW:

Singapore requires that devices be registered through a local authorized representative. Time-to-market is significantly shortened with prior approval from the USA, EU, Canada, Japan, or Australia.