The Health Products Act (HPA) regulates the manufacture, import, supply, and advertisement of health products in Singapore. Originally passed in November 2007, the HPA is being implemented in phases to minimize the impact on the medical device industry in Singapore.
On May 24, 2011, the Health Sciences Authority (HSA) of Singapore announced the final implementation of Phase 3B of the HPA. Phase 3B deals with the registration of Class A and B medical devices in Singapore. The implementation plans are to go into effect from January 1, 2012 onwards. After this date, the supply and sale of all unregistered medical devices is prohibited.
There are currently four risk classifications of medical devices in Singapore – Class A, B, C, and D. Safer medical devices generally fall into Class A or B, while riskier ones into Class C or D. Mandatory product registration is already implemented for Class C and D devices. After the completion of Phase 3B, product registration of Class A and B products will also be mandatory.
To be in compliance with Singaporean regulations, companies who sell Class A or B medical devices must register their products before Jan. 1, 2012. However, since the registration process can take several months, the HSA recommends that companies currently selling medical products should register before August 31, 2011 to be placed on a transition list. The transition list allows medical device companies in Singapore to sell their products before the official approval is granted. Companies who register after the August 31st transition list deadline must wait for official product approval before continuing to sell their products in Singapore.
In addition, the HSA stipulates that if a medical device product is currently used by consumers but is not currently in the market, product registration is not required. However, the medical device company who made or sold the product must still comply with post-marketing regulations (adverse event reporting, product recalls, etc.).