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 Good Distribution Practice for Medical Device in Singapore (GDPMDS)/SS620 or ISO 13485 compliance. GDPMDS/SS620 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.
ASEAN / Asia REP
Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance.
Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative.
ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally.
Whether you are a local or foreign manufacturer, ARQon can assist to:
Be your local representative in the country.
Submit product registrations for all product classifications.
Set up the QMS & technical file for ISO13485, GDP and CE
Hold product license in the country.
Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
Appoint multiple importers and distributors.