Medical Devices Regulatory Services
in Singapore

Overview

Medical devices in Singapore are regulated under the Health Products Act (HPA) and its Health Product (Medical Devices) Regulations 2010.

Regulatory Authority: Health Science Authority (HSA)

Regulation: Health Products (Medical Devices) Regulations 2010

Regulatory Pathway: Medical Device Branch of the Health Sciences Authority (HSA)

Authorized Representative: Singapore Registrant

QMS Requirement: SS 620:2016, Singapore Standard for Good Distribution Practice for Medical Devices, and ISO 13485:2016

Assessment of Technical Data: Health Science Authority (HSA)

Validity of License: All dealer licenses are valid for 12 months from the date of approval

Labelling Requirements: Regulatory guidance, GN- 23 Revised (1 March 2020)

Submission Format: Online

Language: English

HSA Medical Device Classification

HSA applies 16 sets of rules to classify medical devices from lowest to highest risk into Class A, B, C, and D.

Risk classification depends on the factors like duration of contact, degree of invasiveness, intended use, and administration method.

Medical Device Classification, HSA

Risk Class

Risk Level

Medical Device Examples

 Class A

Low risk

Film viewer, surgical hand, sheath, oxygen mask

 Class B

Low to moderate risk

Blood pressure cuff, stem sterilizer

 Class C

Moderate to high risk

Patient monitor, mesin X-ray

 Class D

High risk

Cardiac stents, pacemakers

IVD Classification

In-Vitro Medical Devices are classified below from lowest to highest risk.

 

Risk class

Risk Level

In- Vitro Medical Device Examples

Class A

Low individual risk and low public health risk

Specimen receptacle

Class B

Moderate individual risk or low public health risk or both

Vitamin B12, pregnancy self-testing, anti-nuclear antibody, urine test strips

Class C

High individual risk or moderate public health risk or both

Blood glucose self-testing, HLA typing, PSA screening, Rubella IgM

Class D

High individual risk and high public health risk

HIV blood donor screening, HIV diagnostic kit

Singapore Medical Device Authorized Representative / Registrant 

A Registrant is the liaison between your company and HSA, who handles the device registration listing in Singapore. Singapore medical device authorized representative processes the registration application with the HSA and owns your HSA device registration. Only Singapore-based companies or entities can act as a Registrant; they must also be registered with the HSA. 

HSA Medical Device Registration 

The HSA medical device registration process is conducted through the HSA online Medical Device Information and Communication system (MEDICS). Each HSA device registration is done via a specific evaluation route, depending on the following:

  • Risk classification of the device.
  • Number of prior approvals given by the overseas reference Regulatory agencies.
  • Duration of safety marketing history of the device.

The evaluation route of the device will determine the Turn-Around-Time (TAT), fees, and documents required for registration.

Class A Registration - Class A medical devices are exempted from product registration. However, there is a need to complete the Class A exemption list in MEDICS during the dealer’s license application.

Process flow

Post Approval Device Life Cycle Management

Freyr supports foreign manufacturers in end-to-end medical device lifecycle management, including post-approval activities, such as:

  • Post-approval change management - modifications to existing medical device approvals, such as the addition of new variants and accessories; the addition of new indications of use, among others.
  • Maintenance of medical device approvals and registration through timely payment of administrative and registration fees.
  • Renewal of license.

With a professional team to provide Regulatory support, Freyr supports manufacturers in maintaining the quality and safety needed for approval. Freyr’s intelligence experts keenly observe Regulatory updates and inform clients about steps to be taken for product compliance with prevalent standards.

Summary

The processing time for product registration is mentioned in the following table.

Risk Class

Immediate

Expedited

Abridged

Full Evaluation

Full (Priority Review Scheme)

Class B

Immediate registration upon submission

 

100 working days

160 working days

120 working days

Class C

Immediate registration upon submission (for Class C standalone medical mobile application only)

120 working days

160 working days

220 working days

165 working days

Class D

 

180 working days

220 working days

310 working days

235 working days

Class D (devices incorporating medicinal products)

   

220 working days

310 working days

 

The turnaround time for a change of registrant is 40 working days.

 

NOTE-

  • Class A medical devices are exempted from product registration.
  • Turnaround time excludes the time taken to respond to any requests for clarification or additional information by HSA during the evaluation phase.
Expertise

Freyr Expertise

  • Regulatory Due Diligence for Device Registration with the HSA, Singapore
  • HSA Medical Device Classification and Grouping
  • Support for Conformity Assessment Body (CAB) Assessment
  • ASEAN Common Submission Dossier Template (CSDT) Dossier Compilation
  • HSA Device Registration;
  • Legal Representation
  • Labeling Support
  • Distributor Identification and Qualification
  • Post-marketing Surveillance
  • Post-approval Change Management
  • License Renewal and Transfer
  • Submission and Liaising Services with the HSA