A Complete Guide to Licensing Medical Devices in Singapore
6 minute read
Looking to find out more on what the medical device regulations in Singapore are? Or perhaps you would like to know more about the required documentation for your company to register medical devices.
In this article, we answer all of these questions and cover the key points a company should consider when thinking of applying for a medical device license in Singapore.
- What are the regulations and classifications for medical services and medical devices in Singapore?
- What is a medical device?
- Which types of medical devices will require a license from HSA?
- What are the different medical device risk classifications?
- What are the requirements to apply for a license?
- What are evaluation routes?
- What is the Priority Review Scheme?
- How much are the fees and what is the turnaround time for product registration?
- What are the submission requirements?
- What are the good distribution practices for medical devices?
- What does the medical device process look like?
- Next steps
What are the regulations and classifications for medical services and medical devices in Singapore?
The medical services industry in Singapore is regulated by The Health Sciences Authority (HSA) that administers the national regulatory framework for pharmaceuticals, complementary medicines, medical devices, and other health products.
A company must be licensed by HSA to import medical devices in Singapore.
To explain further, we have partnered with Access-2-Healthcare – a leading global consultancy that helps medical technology businesses in Singapore – to share more about the HSA licensing process, Good Distribution Practice for Medical Devices (GDPMDS) and requirements depending on the risk classification of each medical device.
What is a medical device?
A medical device is defined as “any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related articles used for achieving a medical function, that is diagnostic, preventive or therapeutic in nature but without involving pharmacological, immunological or metabolic action”.
Having the product correctly defined right in the beginning potentially helps in saving months of going in circles!
Which types of medical devices will require a license from HSA?
The HSA requires a license from medical devices which are used to either:
- Diagnose, alleviate or treat a medical condition; or
- Measure and monitor bodily functions.
Companies are required to obtain the relevant licenses for medical devices that have physical or mechanical effects when used on human bodies prior to import and supply.
What are the different medical device risk classifications?
Medical devices in Singapore are classified into 4 risk classes – Class A, B, C and D; Class A being the lowest risk and Class D the highest risk.
|A||Low risk|| |
|B||Low-moderate risk|| |
|C||Moderate-high risk|| |
bone fixation plate
|D||High risk|| |
Factors affecting medical device risk classification include:
- Duration of medical device in contact with the human body.Degree of invasiveness.
- Whether the medical device delivers medicinal products or energy to the patient.
- Whether they are intended to have a biological effect on the patient.
- Local versus systemic effects (e.g. conventional versus absorbable sutures).
What are the requirements to apply for a license?
Each device registration is done via a specific evaluation route. The evaluation route for your device depends on:
- Risk classification of device.
- Number of prior approvals given by overseas reference regulatory agencies.
- Duration of safe marketing history for device.
- The evaluation route of the device will determine the turn-around-time (TAT), fees, and documents required for registration.
What are evaluation routes?
Devices with prior authorization from reference regulatory agencies in Europe, US, Canada, Japan, and Australia are eligible for abridged evaluation routes.
What is the Priority Review Scheme?
The Priority Review Scheme provides options to gain faster registration and market entry. Applicants are to submit to HSA through the Full Evaluation route.
Applicants can opt for one of the two routes, Route 1 or Route 2, under the Priority Review Scheme if a Class B, C or D medical device falls under one of the five healthcare focus areas (cancer, diabetes, ophthalmic, cardiovascular or infectious diseases and intended for an unmet clinical need).
How much are the fees and what is the turnaround time for product registration?
The table below entails the average fees and turnaround time (in working days) for different registration routes of each risk class:
|Risk Class|| |
|Class B||100 – 160||$925 – $5,300|
|Class C||120 – 220||$3,090 – $8,600|
|Class D||180 – 310||$5,560 – $17,100|
What are the submission requirements?
Applicants are required to submit documents and information in the ASEAN Common Submission Dossier Template (CSDT) format, including but not limited to:
- Proof of QMS, reference agency’s approval(s), marketing history and safety declaration.
- Essential Principles Checklist and Declaration of Conformity.
- Design Verification & Validation Reports.
- Clinical Evidence.
- Device Labelling.
- Risk Analysis.
Documents and materials submitted to HSA must be in English. All documents can be provided in electronic format and do not require international legislation.
What are the good distribution practices for medical devices?
Wholesalers and importers dealing with medical devices in Singapore shall conform to the requirements of Good Distribution Practice for Medical Devices (GDPMDS) as it ensures a quality management system is in place to maintain device quality and integrity throughout the distribution process.
Companies who are involved in storage, trade and distribution of medical devices are to obtain SS 620 GDPMDS certification prior to applying for an Importer or Wholesaler Licence. The scope of the GDPMDS certification shall specify the activities performed and categories of medical devices handled by the companies, including outsourced activities (if any) and any special storage and handling conditions.
Companies involved in GDPMDS activities will be audited based on appropriate procedures documentation to demonstrate consistency of quality assurance.
What does the medical device process look like?
Need help with medical device classification, registration and GDPMDS?
Access-2-Healthcare helps medical device companies end-to-end, with gaining regulatory approvals, market access, post-market management in Singapore and other countries. Find out more about how they can help you here.
This guest article was brought to you in conjunction with Access-2-Healthcare, a global consulting company that helps to overcome various challenges faced by medical technology companies by executing end-to-end market entry and product launch activities in various countries.
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