The Singapore Parliament is conducting a preliminary review on new legislation to regulate all health products and active ingredients. The Health Products Bill was first presented to the Parliament on January 22, 2007. It seeks to regulate the manufacture, import, supply, presentation, and advertisement of medical products and active ingredients used in the manufacture of medical products.
Singapore currently has voluntary registration for medical devices and required registration for pharmaceuticals, but this new bill would require registration and licenses for the manufacture, import, and supply of all medical products. Manufacturers would need a manufacturing license in addition to product registration, while importers would need to apply for an importer’s license and product registration. Wholesalers must hold a valid wholesaler’s license and can only supply registered medical products.
Registration of a health product would be valid so long as the registrant continues to pay the appropriate retention fees to the government and the registration is otherwise not suspended or cancelled.
The new bill would also regulate medical product advertising, with penalties for false or misleading claims. Manufacturers, importers, suppliers, or registrants of medical products must also report any defects or adverse events related to their product. Other safety measures and quality assurances include holding importers, manufacturers and wholesalers accountable for the import or sale of medical products that are counterfeit, tampered with, unwholesome, or adulterated.
The Health Sciences Authority (HSA) would be the main regulatory body responsible for the administration and enforcement of this bill. The HSA would keep records and maintain a register of licensees and all registered health products.