On February 12, 2007, the Singapore Parliament passed the Health Products Act 2007 into law. This represents a major change to Singapore’s regulatory system, bringing a number of medical products under mandatory regulation, starting with medical devices. Previously, medical devices were registered on a voluntary basis. The Singapore Health Sciences Authority (HSA) plans to begin implementation this month.
The HSA has detailed three implementation phases. Phase 1 will consist of implementing certain duties and obligations on medical device dealers, as well as regulating advertising and promotions. Dealers will be obligated to keep distribution and complaint records and to report adverse events to the product manufacturer and the HSA. In addition, medical device dealers must comply with product recalls if ordered to by the HSA. Any requests from the HSA to submit documents and products for testing must also be followed. This phase will start from October 2007 and last to April 2008.
In Phase 2, the HSA will begin to license parties dealing with medical devices. During this Phase, all manufacturers, importers, and wholesalers will need to apply for licenses to conduct business in Singapore. In addition, product registration must also be started during Phase 2. To register under the Act, a company will need to be Singapore-based and registered with the ACRA (Accounting & Corporate Regulatory Authority).
For product registration requirements, the HSA plans to use the ASEAN Common Submission Dossier Template (CSDT). Medical devices already registered under the previous Voluntary Product Registration Scheme will be transferred to the Singapore Medical Device Register. Phase 2 will last from April 2008 to October 2009. However, the deadline for low-risk medical devices is later, October 2010.
During Phase 1 and 2, the manufacturing, import and wholesale of medical devices will not be restricted, except for restrictions based on previous legislation such as the Medicines Act and the Radiation Protection Act. This will be the preparation period in which all companies will need to be registering their devices, if they have not done so voluntarily already.
At Phase 3, beginning in October 2009, unlicensed parties will not be allowed to import, manufacture or sell medical devices. In addition, all medium-risk and high-risk medical products will need registration to be sold. Phase 3 will not go into effect for low-risk medical devices until October 2010.
The HSA has inquiry forms for product-specific questions as well as information on arranging face-to-face meetings on their website at http://www.hsa.gov.sg/.