Singapore HSA Registration

What Is HSA？

With a well-established and advanced healthcare system, Singapore is one of the most important markets for medical devices in Asia. 

the Dealer's License is a must before manufacturing, importing, or supplying medical devices in Singapore to engage in related business. they can apply for it through HSA's Medical Device Information and Communication System(MEDICS) online. 

Medical devices/IVD products here in Singapore are classified into four risk classes, A/B/C/D.

Authorities and Regulations：

- Regulatory Body:  Health Products Regulations Group (HPRG) of Health Sciences Authority (HSA).

- Regulatory requirements:

✔ Health Products Act2007

✔ Health Products (Medical Devices) Regulations 2010 

✔ ASEAN Medical Devices Directive (AMDD) 

- Regulatory pathway: Pre-market notification/registration

- Authorized representative: Local entity company

- QMS requirements: GDPMDS  or ISO 13485

Product Classification：

In Singapore, in vitro diagnostic products (IVD) are considered a subset of medical device products (MD). The rules for classifying medical devices in Singapore are based on the recommendations of the Global Harmonization Task Force (GHTF). All medical devices are required to be HSA registered firstly except Class A non-sterile low-risk medical devices, which are exempt from product registration or are available under specific conditions approved by the HSA. 

Please refer to our quick-guide-to-md-registration-and-licensing_may-2021.pdf  for an overview of medical device product registration and licensing.

Our Services At A Glance:

• Device Classification Services 

• Foreign manufacturer registration guidance

• Preparation of technical documents and instructions according to HSA requirements

• local representative services

• Labeling guidance

• Assistance with agency regulatory due diligence