HSA IVD Medical Device Pre-Market Approval Registration Service

27 May 2021 | Uncategorized

HSA IVD Medical Device Pre-Market Approval Registration Service



Registration and Approval of Medical Devices in Singapore
Singapore is internationally renowned for its world-class healthcare system and regionally, we serve as a popular hub for medical treatment and care. As such, there is a regular demand for high-quality modern medical technology. Headquartered in Singapore, Clarityscreening is fully equipped to help you achieve regulatory compliance to begin selling your medical device in this burgeoning market. We can serve as your in-country representative and fully support your medical device registration with the Health Sciences Authority (HSA) in Singapore.

Classification and regulations in Singapore
The HSA regulates the approval of medical devices in Singapore. Being a member of the Association of Southeast Asian Nations (ASEAN), Singapore’s regulatory system adheres to the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010. These regulations determine the classification of medical devices in Singapore and the different registration routes.
There are four tiers of device classification – A, B, C or D.
Class A products are of the lowest-risk while Class D products are of the highest-risk.
Devices with prior authorization in the US, Europe, Canada, Australia, or Japan are eligible for shorter approval processes.

HSA submission dossier
The HSA submission dossier, or technical file, adheres to the ASEAN CSDT (Common Submission Dossier Template). The required information in your submission is dependent on the device class and evaluation route. In general, supporting documents from an EU technical file can satisfy many HSA submission requirements. A Declaration of Conformity to the Essential Principles must also be submitted. Upon approval, your product will be entered into the Singapore Medical Device Register (SMDR).

Local representation for overseas manufacturers
Foreign medical device manufacturers must engage a Registrant to represent them to submit their application for device approval. The Registrant must be a Singapore-based company, with local employees, and must be registered with the HSA. This is where Clarityscreening comes in.
We can support you by:

– Serving as your in-country Registrant to liaise with HSA throughout the registration process
– Helping to determine your device classification and registration route
– Assisting with the preparation of the HSA submission dossier
– Identifying opportunities for authorization and documentation in other markets for more efficient registration in Singapore
– Proposing an optimal device grouping strategy to expedite registration processes and reduce unnecessary costs
– Assisting with post-market surveillance, vigilance, adverse-event reporting, if required

Your Registrant in Singapore is responsible for your device registration so it is crucial to choose an ideal representative. Registrations can be transferred to a different Registrant only if the current Registrant agrees. Here at Clarityscreening, we have all the expertise and resources you need to secure regulatory approval with speed and ease.