Medical device registration in Singapore
All medical devices whether manufactured domestically or imported, must be registered with the Health Science Authority (HSA) before they can be supplied in Singapore, except for Class A low-risk medical devices, which are exempted from product registration. All product registration transactions including any future renewals or change notifications are conducted online through the Medical Device Information and Communication System (MEDICS).
Who can register a medical device in Singapore?
Only companies registered locally in Singapore with the Accounting and Corporate Regulatory Authority (ACRA) may apply to obtain a dealer license and register a medical device. Once registered with ACRA, a company must create a Client Registration and Identification Service (CRIS) company account with the HSA; this allows companies to access the online MEDICS portal and conduct electronic transactions such as product registrations with the HSA.
Once the CRIS account is ready, a company can apply simultaneously for a dealer license according to their activity: Manufacturer’s License, Importer’s License or Wholesaler’s License (import and export) as well as a Registrant Account. Only companies which have a Registrant Account can register a medical device in Singapore.
As only local (Singaporean) companies can apply for a Registrant Account, foreign manufacturers, therefore, have three (3) possibilities to register their medical device in Singapore:
Set up a legal subsidiary entity
to register the medical device
Appoint a local importer or wholesaler
who has a valid dealer’s license, Good Distribution Practice for Medical Devices (GDPMDS) certification and a Registrant Account in Singapore to register the medical devices via MEDICS
Appoint an independent third party
such as Andaman Medical to register the medical devices. Andaman Medical has a valid Registrant Account and acts directly on behalf of foreign manufacturers. We register and maintain your device license which also means you have the freedom to appoint as many importers or wholesalers for your device as you require while the product license will not be affected by any changes in the distributor network
What is considered a medical device in Singapore?
As set out in the Health Products Act 2007, a ‘medical device’ —
a) means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purpose(s) of:
i) diagnosis, prevention, monitoring, treatment or alleviation of any disease;
ii) diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;
iii) investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;
iv) supporting or sustaining life;
v) control of conception;
vi) disinfection of medical devices; or
vii) providing information by means of in vitro examination of specimens derived from the human body, for medical or diagnostic purposes,
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means, and which is not a cell, tissue or gene therapy product;
and
b) includes the following articles:
i) any implant for the modification or fixation of any body part;
ii) any injectable dermal filler or mucous membrane filler;
iii) any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.
Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostics.
Classification of medical devices in Singapore
In Singapore, medical devices are classified into 4 risk classes (Class A, Class B, Class C and Class D) according to the level of risk it poses to patients, user, and other persons.
The risk presented by a medical device depends substantially on its intended purpose and on the effectiveness of the risk management techniques applied during the design, manufacture, and use. Hence, the risk classification depends upon the design and claims made by the product owner and on its intended purpose.
Classification of a medical device will depend upon a series of factors, including:
- How long the device is intended to be in use
- Whether the device is implantable
- Whether the device is active
- Whether the device contains a drug or biologic component
The classification rules are adopted from the guidance developed by the Global Harmonization Task Force (GHTF).
The medical device risk class determines the necessary documentary requirements for registration. The higher the class of medical device, the more in-depth information is required for submission in order to register.
Medical device grouping in Singapore
In Singapore, medical devices and IVDs may be grouped into a particular category for registration. A medical device often comes with component(s), part(s), or accessories. The purpose of these items can be as support for the main unit/parent device or to be used altogether. These may also stand as consumables to the parent device. The medical device may be grouped into one of the following categories:
Groupings are allowed if all of the following conditions are met:
- The products are from the same product owner
- The products have the common intended use.
- The products are used in combination to achieve the same intended use.
- The applicable specific conditions are fulfilled for the individual grouping categories.
The grouping categories are as follows:
Single
Family
System
IVD Test Kit
In-vitro Cluster
Group
The registration process
All medical device and IVD product registrations must be submitted by the Registrant online via MEDICS. Once the submission has been completed and the payment has been collected by the authority, an officer will be randomly assigned to review the Medical Device application. Upon reviewing the documents, the officer will generate input requests via MEDICS to request further documents and clarifications. All communication is via MEDICS system which sends an automated message to the registrant’s email address. At this stage, HSA will evaluate the submission again, and if successful a condition of approval will be issued or if not, then the submission will be rejected.
Although exempted from product registration, Class A medical devices shall comply with the Essential Principles for Safety and Performance for Medical Devices as specified in the Regulations prior to their placement on the Singapore market. And all class A medical devices must be submitted for exemption listing via MEDICS.
What documents are required to register medical devices in Singapore?
Various documentation is required to register a medical device in Singapore. The language accepted for submission is English. In general, you will be required to submit Common Submission Dossier Template (CSDT), executive summary, device description, any pre-clinical studies, clinical evaluation, device labelling, instructions for use, a risk analysis, proof of quality management system, manufacturing information, essential principle checklist along with declaration of conformity and of course any existing regulatory approvals or market authorizations already obtained.
Certain products require additional documentation such as those which contain or transmit radiation or have Bluetooth and wireless network features.
Typical fees and timelines
A fee is payable for each submission for new medical device registrations, renewals or change notifications. This is a non-tax fee. The HSA will raise the fee invoice automatically upon submission to the MEDICS platform. Payment must be made within 7 (seven) calendar days. For whatever reason if payment is not processed within the deadline, the submission will expire, and a new submission will be required.
A fee is payable for each submission for new medical device registrations, renewals or change notifications. This is a non-tax fee. The HSA will raise the fee invoice automatically upon submission to the MEDICS platform. Payment must be made within 7 (seven) calendar days. For whatever reason if payment is not processed within the deadline, the submission will expire, and a new submission will be required.
Fees:
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| Risk Class | Application Fees | Evaluation Fees | |||||
|---|---|---|---|---|---|---|---|
| Immediate Class B Registration | Expedited | Abridged | Full | Priority Review Scheme | |||
| Full (Route 1) | Full (Route 2) | ||||||
| Class B | S$515 | S$925 | S$1,850 | S$3,605 | S$4,100 | S$5,300 | |
| Class C | S$515 | S$3,090 | S$3,090 | S$3,605 | S$5,870 | S$6,600 | S$8,600 |
| Class D | S$515 | S$5,560 | S$5,870 | S$11,600 | S$13,200 | S$17,100 | |
| Class D, devices incorporating medicinal / therapeutic products | S$515 | S$10,200 | S$75,200 | ||||
Timeline:
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| Risk Classification | Target Turn-Around-Time for Registration (in working days) | ||||
|---|---|---|---|---|---|
| Immediate | Expedited | Abridged | Full | Full (Priority Review Scheme) | |
| Class B | Immediate Registration upon Submission | 100 | 160 | 120 | |
| Class C | Immediate registration upon submission (for Class C standalone medical mobile application only) | 120 | 160 | 220 | 165 |
| Class D | 180 | 220 | 310 | 235 | |
| Class D, devices incorporating registrable medicinal /therapeutic products | 220 | 310 | |||
*Turnaround time excludes the time taken to respond to any clarifications from Health Sciences Authority during review phase.
For Medical Device and IVD renewals
| Class | Fee | Timeline |
|---|---|---|
| Class B | S$36 | Immediate Renewal upon retention fee payment. |
| Class C | S$62 | |
| Class D | S$124 |
For Medical Device and IVD change notification
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| Change Category | Class B | Class C | Class D | |||
|---|---|---|---|---|---|---|
| Fee | Timeline | Fee | Timeline | Fee | Timeline | |
| Administrative | S$515 | 30 | S$515 | 30 | S$515 | 30 |
| Review | S$515 | 45 | N.A. | N.A. | N.A. | N.A. |
| Technical | N.A. | N.A. | S$1,750 | 75 | S$2,880 | 90 |
*Timeline excludes the time taken to respond to any clarifications from Health Sciences Authority during review phase.
How Andaman Medical can help:
Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.
Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.
Our registration services include:
- Standard product registration
- Abridged product registration
- Special access product registration
- Renewal of product registration
- Amendment and change notification
- Product license transfer
Our authorised representative services include:
- Liaison with the local authorised government agency on all regulatory issues relating to your medical device including amendment and change notifications
- Regulatory monitoring to alert you to any changes or new regulation applicable to your product
- License holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
We also offer additional support services such as:
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market
- Online regulatory training