Medical Device Registration in Singapore 2018-05-31T10:24:40+08:00

Market Opportunity in Singapore

According to the World Health Organization (WHO), Singapore’s healthcare system ranks sixth globally and has the fourth best healthcare infrastructure in the world.

Singapore has been serving as a healthcare and medical hub in the ASEAN region, drawing more than 350 thousand patients annually with its high-quality healthcare infrastructure. The government spends approximately 4% of its GDP annually on healthcare, and this is expected to increase to 8% GDP in a long-term healthcare plan. It is estimated that healthcare expenditure will increase from $6 million in 2015 to $9.6 billion per year by 2020. Among the ASEAN members, Singapore is by far the most developed and efficient healthcare system in the region.

Singapore has a national healthcare plan which covers almost 100% of its population. The healthcare plans include Medisave, MediShield Life, Medifund and Eldershield. Singapore continues to strengthen its reputation as the ASEAN region’s healthcare hub and center of healthcare excellence. With the consistent increase in the government’s expenditure in the medical industry, the island is an attractive market to both local and foreign investors.

Andaman Medical can act as your in-country representative

Medical devices and IVD devices are well regulated under the Health Sciences Authority (HSA) who oversees and safeguards the quality, safety and efficacy of Medical devices and IVD devices in Singapore. As with many other countries in the ASEAN region, foreign manufacturers who are not established in Singapore will need to appoint a local representative to register the medical device in the country. Andaman Medical offers services to act as your local representative to handle product registration in the country. We can assist in the preparation of the submission dossier in accordance with the ASEAN Common Submission Dossier Template (CSDT) as per the HSA requirements, submit your application, and liaise with the authorities until marketing authorization for your devices in Singapore is obtained.

Services

Foreign manufacturers who are not established in Singapore will need to appoint an in-country representative known as a Registrant to handle product registration. This Registrant must be a Singapore-based company and Accounting and Regulatory (ACRA) registered. Andaman Medical is able to act as your Registrant to manage your product registration. Furthermore, as your Registrant, we can manage all post-marketing activities including application submissions to the authorities notifying them of changes made to a registered device, complaint handling and take care of field safety corrective actions including recalls etc.
Medical device registration in Singapore is submitted in accordance with the ASEAN Common Submission Dossier Template (CSDT). We can assist you in the preparation of the submission dossier in accordance with the CSDT format, submit your application via the Medical Devices Information and Communication System (MEDICS) online platform, and follow up and liaise with the authorities until you obtain the marketing authorization to market your product in Singapore.
In Singapore there are three types of dealer’s license: manufacturer’s license, importer’s license and wholesaler’s license. All licensees must comply with an applicable Quality Management System such as ISO 13485 or GDPMD certification. Andaman Medical is able to support you with the implementation and maintenance of an appropriate quality management system that fulfils regulatory requirements.
Andaman Medical offers general consulting services including the provision of regulatory intelligence reports, medical device classification and registration consultancy.