Medical and IVD devices must be imported into Singapore by a licensed importer. Traditionally this function is performed by a commercial distributor that is also involved in demand creation, servicing, installation, training, and fulfillment. Due to Singapore's small geographic size and other favorable characteristics of this English-speaking country, foreign medical device and IVD manufactures can take on these business functions directly and eliminate traditional distributors with high margins. Emergo's importing services in Singapore allow foreign manufacturers to adopt a more profitable sales model while maintaining regulatory compliance.
The role of a Singapore Medical Device and IVD Importer
Any entity involved in the import or wholesale of medical devices must comply with Singapore’s Health Products Act 2007 (Act), Health Products (Medical Devices) Regulations 2010 (Regulations), and any applicable legislative requirements. All importers must maintain a quality system that has been audited and certified to either ISO 13485 or Good Distribution Practice Medical Devices Singapore (GDPMDS). Emergo is a professional, independent consulting company that focuses 100% on medical device and IVD regulatory affairs and quality management. Your success in Singapore is our goal.
How we can assist with importing your device into Singapore
Through our local office in Singapore, we can act as your licensed importer, as well as your Registrant. In this role, we will:
- Maintain GDPMDS or ISO 13485 certification.
- Maintain a list of imported Class A medical devices, if applicable.
- Processing of import paperwork with Customs.
- Act as your primary regulatory contact with the HSA.
- Provide a copy of our Import and Wholesale Licenses, as needed, for customs clearance.
- Act as the Licensed Importer of Record.
As an experienced regulatory consulting firm with offices worldwide, we perform regulatory and/or distribution tasks for hundreds of medical device manufacturers. You can feel confident that the importation and regulatory compliance aspects of your business in Singapore will be handled professionally.
Please contact us for more information on how we can become your licensed medical device importer in Singapore.