FDA Medical Device Registration in Singapore Explained

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Medical Device Regulations and Classification

Understanding the regulatory landscape for medical devices in Singapore is crucial for companies looking to expand their market reach. The Health Sciences Authority (HSA) oversees the regulation of medical devices in Singapore, operating under the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010. These regulations establish the framework for device classification and registration processes in the country.

Medical devices are classified into four tiers (Class A, B, C, and D) in Singapore, with each class representing varying levels of risk. For companies seeking to market their products in Singapore, it’s essential to comprehend the classification criteria and the corresponding registration routes for each class.

Notably, devices with prior authorization from recognized regulatory bodies such as the US FDA, European CE Mark, Health Canada, Australia’s Therapeutic Goods Administration (TGA), or Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) may qualify for abridged evaluation routes in Singapore. This streamlined process expedites the registration process for qualifying devices, facilitating market entry and expansion opportunities.

HSA medical device submission dossier preparation

Preparing a submission dossier for HSA medical device registration is a critical step for companies aiming to market their products in Singapore. The dossier, following the ASEAN CSDT format, contains essential information required for evaluation by the Health Sciences Authority (HSA). Depending on the device class and evaluation route chosen, documentation from an EU technical file can often fulfill many requirements.

A Declaration of Conformity and the Essential Principles must also be included in the submission dossier. Upon approval, the product is listed in the Singapore Medical Device Register (SMDR) database, granting it market access in Singapore. It’s imperative for companies to meticulously prepare their submission dossiers to ensure compliance with regulatory standards and facilitate a smooth registration process.

New HSA Government Fees in Singapore

Fees	Class B	Class C	Class D	Class D with a registrable drug
Application fee	$530	$530	$530	$530
Immediate route fee	$950	$3,180	N.A.	N.A.
Expedited route fee	N.A.	$3,180	$5,730	N.A.
Abridged route fee	$1,910	$3,710	$6,050	$10,400
Full route fee	$3,710	$6,050	$11,800	$75,400
Full route (Priority Review Scheme Route 1)	$4,220	$6,800	$13,400	N.A.
Full route (Priority Review Scheme Route 2)	$5,460	$8,800	$17,000	N.A.
Annual retention fee for SMDR listing	$37	$64	$128	$128

*All fees are in Singapore dollars. S$1,000 = US$705 as of January 2022.

New Change Notification Review Fees in Singapore

The Health Science Authority in Singapore has recently revised the change notification review fees, marking an approximate 3% increase. Here’s a breakdown of the updated fees:

Type	Class B	Class C	Class D
Administrative	$530	$530	$530
Review	$530	N.A.	N.A.
Technical	N.A.	$1,800	$2,970

*All fees are in Singapore dollars, with S$100 equivalent to US$70.5 as of January 2022.

New Retention Fees in Singapore

Singapore’s Health Sciences Authority (HSA) has implemented new retention fees for medical device registration, effective from July 1, 2022.

Classification	2021 Fees	New Fees (beginning July 1, 2022)
Class B	$36	$37
Class C	$62	$64
Class D	$124	$128
Class D with registrable drug	$124	$128

*All fees are in Singapore dollars. S$100 = US$70.5 as of January 2022

Documents Required to Register Medical Devices in Singapore?

To register medical devices in Singapore, companies must adhere to specific documentation requirements. The submission must be in English and typically includes the following:

Common Submission Dossier Template (CSDT): A standardized template for submitting essential information about the medical device.
Letter of Authorization: To submit applications for the evaluation and registration of medical devices to the Health Sciences Authority on our behalf.
Executive Summary: A concise overview of the device and its intended use.
Device Description: Detailed information about the device, including specifications and intended purpose.
Pre-clinical Studies: Data from studies conducted to assess the safety and performance of the device.
Clinical Evaluation: Evaluation of the device’s clinical data and evidence of its effectiveness.
Device Labelling and Instructions for Use: Information on how to use and label the device safely and effectively.
Risk Analysis: Assessment of potential risks associated with the device and strategies to mitigate them.
Quality Management System: Documentation proving adherence to quality management standards and Manufacturing Flow chart.
Manufacturing Information: Details about the manufacturing process and facilities.
Essential Principle Checklist and Declaration of Conformity: Confirmation that the device complies with essential principles and regulatory requirements.
Existing Regulatory Approvals: Any previous approvals or authorizations obtained for the device.

Why Choose Maven

When it comes to medical devices registration in Singapore, MAVEN stands out as a top choice for several compelling reasons. With our extensive expertise and proven track record, we offer unparalleled support throughout the registration process, ensuring seamless compliance with regulatory requirements.

MAVEN’s team of experts possesses in-depth knowledge of Singapore’s regulatory landscape, enabling us to navigate the intricacies of medical devices registration with precision and efficiency. We understand the importance of timely approvals and strive to expedite the registration process to minimize delays and facilitate market entry for your devices.