Medical Device Registration and Approval in Singapore

ANSWERED ON THIS PAGE:

• What are the key medical device regulations in Singapore?
• Do foreign manufacturers need and in-country representative?
• What is the major documentation required to register medical devices in Singapore?

Despite its small geographic size, Singapore has one of the largest and most advanced healthcare systems in the world. People throughout Asia rely on Singapore's robust healthcare infrastructure, so there is consistent demand for state-of-the-art medical technologies. Emergo has the expertise and resources to help you secure regulatory approval in one of the most significant medical device markets in Asia.

Medical device regulations and classification in Singapore

Medical devices in Singapore are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). Singapore is a member of the Association of Southeast Asian Nations (ASEAN) and its regulatory system is based on the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010. These regulations dictate how medical devices are classified in Singapore and the registration routes for each class.

Device classification in Singapore is based on a four-tier system (Class A, B, C, and D), with Class A assigned to the lowest-risk products and Class D assigned to the highest-risk products. Devices with prior authorization in the US, Europe, Canada, Australia, or Japan are eligible for abridged evaluation routes.

HSA medical device submission dossier preparation

The HSA submission dossier, or technical file, is based on the ASEAN CSDT (Common Submission Dossier Format). The information required in your submissions depends on your device class and selected evaluation route. For the most part, documentation from an EU technical file can be used to satisfy many supporting documentation requirements. You must also prepare a Declaration of Conformity to the Essential Principles. Once approved, your product is listed in the Singapore Medical Device Register (SMDR) database.

In-country representation for foreign device manufacturers

Foreign medical device manufacturers must appoint a Registrant to submit their device application and represent them to the HSA. The Registrant must be a Singapore-based company, with local staff, and registered with the HSA. Your representative in Singapore controls your device registration so choose your Registrant carefully. Registrations can only be transferred to another Registrant if the current Registrant agrees to relinquish it.

Emergo can fully support your medical device registration with the HSA.

With an office in Singapore, Emergo is equipped to help you achieve regulatory compliance and start selling your medical device in this growing market. Here's how we can help:

• Identify your device classification and appropriate registration route
• Act as your in-country representative and liaise with HSA throughout registration process
• Assist with technical dossier preparation and CSDT format
• Identify opportunities to leverage authorization and documentation for other markets to efficiently register in Singapore
• Advise on optimal grouping strategy to minimize registrations and associated costs
• Assist with post-market surveillance, vigilance, adverse-event reporting, if needed

Emergo is a full-service regulatory consulting firm that specializes in the global medical device industry. Your success in Singapore is our priority.

Common questions regarding medical device registration in Singapore

Is registration required for Class A Non-sterile devices?
No, they are exempt from the registration process and do not require a Registrant. Further, telehealth products (such as mobile applications) solely for well-being or lifestyle purposes are not subject to regulatory controls provided they include a clarification statement in their labels to state that the device is not meant for medical use.

Is registration required for Class A measuring devices?
No. Unlike the EU, measuring devices are not given an elevated regulatory scrutiny in Singapore.

What is the QMS requirement in Singapore?
Manufacturers of devices other than Class A must submit proof that their quality system complies with one of the following standards: ISO 13485, US FDA cGMP, or Japan MHLW Ordinance #169.

Does the HSA require home-country approval?
No, approval in your country of origin is not required. However, if your home country is one of the reference markets, you may be eligible for an Abridged or Expedited registration process. Emergo can help you evaluate the best registration pathway based on your authorization in other markets.