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Medical Device Regulation Singapore
Medical Device registration is compulsory in Singapore. This means you will need to register your medical device before supplying it in Singapore. Find out how to complete your product registration here.
Medical Devices are classified into 4 classifications: class A B C D. Class A medical device needs only to be notified to the authority. Class B C D medical devices need to go through the formal registration process which consists of submission of technical documentations (in the form of CSDT) to HSA.
Medical manufacturers (residing in Singapore) and medical device importers and wholesalers require dealer licenses from HSA. Good Distribution Practice or ISO 13485 Quality Management Systems are required for dealer license application. Please see the information below to more specific details on Medical Device Regulation Singapore.
Regulatory Body
Health Sciences Authority (HSA)
Legislation
Health Products Act (HPA),
Health Products (Medical Devices) Regulations 2010
Medical Device Definition
Medical device
“Medical device” means —
(a) 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 purposes of —
(i) diagnosis, prevention, monitoring, treatment or alleviation of 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 intended function by such means, and which is not a cell, tissue or gene therapy product; and
(b) 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.
Registration mandatory or voluntarily
Mandatory
Local Representative Requirements
A local legal company is needed to be the license holder (registrant).
Local importer and wholesaler must have Good Distribution Practice Certification and attain importer/ wholesaler licenses from HSA.
Registration Owner
Foreign manufacturer AND registrant
Device Classification System
A, B, C, D with rules specified in Guidance 13.
HSA | Guidance documents for medical devices
Quality Management System Requirements
ISO 13458 for the actual manufacturing site/s
Local testing requirements (if applicable)
Not applicable
Submission language/ IFU and Label language
English
Validity of the Registration
No expiry as long as annual listing fee is paid by the registrant
Authority fees
HSA | Fees and turnaround time for medical devices
Official authority review timelines
HSA | Fees and turnaround time for medical devices
Other requirements and regulations
radiation/ lasers/ needs to be register with NEA
WIFI needs to be register with IMDA
Parties involved in the process
Foreign manufacturer
Local Registrant
Importer (for importation only)
Wholesaler (for wholesale only)
HSA
Submission Requirements under Medical Device Regulation Singapore
You would be expected to provide supporting technical documentation like executive summary, product description, product specifications, intended use/ indications, instructions for use, label, physical, chemical, biological testing (where applicable), sterilization validation (where applicable), software verification and validation (where applicable), clinical evaluation, risk analysis, manufacturing process flow chart/ description, list of configuration/ models/ accessories, declaration letters on post market vigilance and marketing history and declaration (where applicable) to the Health Sciences Authority through their online submission portal (MEDICS).
gn-15-r7-5-guidance-on-medical-device-product-registration-(aug21-pub).pdf (hsa.gov.sg)
Contact
For more information on Medical Device Regulation Singapore, contact us here.
Or simply email us at info@cmsmedtech.com
