MEDICAL DEVICE REGULATION IN SINGAPORE

Singapore is one of the ASEAN countries where the product registration must be done by a local registrant. Although the country is small, many medical devices are made available due to the needs of consumers and healthcare professionals.

The Health Sciences Authority (HSA) was formed since 2001 when the voluntary registration was introduced. There were over 4000 medical devices that were approved back then. Health Products (Medical Devices) Regulation was implemented in August 2011 and all medical devices have to be approved by the Medical Device Branch of HSA before it can be supplied in Singapore.

There are benchmarking route of applications available in Singapore as Singapore’s regulatory framework is based on IMDRF (formerly known as GHTF).

Medical devices including IVD is classified into 4 classes, namely the low-risk Class A, low-medium risk Class B, high-medium Class C and the highest risk Class D. For IVD in Singapore, the control is slightly different from European Union(EU).

Regardless of its risk classification, all medical devices (unless exempted from product registration) for importation and supply (in Singapore or re-export) must meet one of the following criteria:

·         Listed on the Singapore Medical Device Register (SMDR);

·         Listed on the Transition List; or

·         Authorised via one of the Authorisation Routes.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN SINGAPORE

Class A sterile, Class B, Class C and Class D medical devices must be submitted to HSA before it can be supplied in Singapore. Grouping is allowed in Singapore and is named Single, Family, System, Test kit or Group. Product registration dossier must be prepared in accordance with the ASEAN Common Submission Dossier Template (CSDT). During the product registration application, ARQon will work with manufacturers on the device classification, grouping and CSDT preparation.

In Singapore, applications must be submitted online via Medical Device Information and Communication Systems (MEDICS). Prior to submission, the company has to apply for a CRIS (Client Registration and Identification Service) account and registered as a CRIS Administrator to gain access to MEDICS.

The company must be a local entity company, otherwise, ARQon can submit the application with authorization from the Product Owner. The local entity is known as a Local Authorised Representative. The appointed Importer and Wholesaler must have a Dealer License with GDPMDS or ISO 13485 compliance. GDPMDS certification should be obtained from a recognized certification body that is accredited by the Singapore Accreditation Council.

Class A non-sterile medical device requires a simple notification and Dealer’s License is still applicable to the local company entity.

There are different abridged evaluation routes available in Singapore where it can be 0 approval time. If the medical device has been evaluated and obtained market clearance in at least one of the GHTF founder member countries, abridged evaluation route is applicable. Otherwise, the full evaluation route of application applies.

The Turn Around Time (TAT) for the Product registration will vary depending on the device class and type of evaluation.