The Health Sciences Authority (HSA) has published the final version of the document “Medical Devices Product Classification Guide” after concluding the discussion with stakeholders. This document aims to help the stakeholders in determining whether a product is a medical device or not.
Medical devices (MDs) are defined in the Health Products Act (HPA). Those products falling within the scope of such definition are regulated by the HSA. Some products, though, are harder to classify whether they are MDs or not. This guide has been published for the expressed purpose of clarifying such confusion.
If a product is classified as an MD in another country, it does not automatically mean that it would be the same in Singapore. Applicants should always consult the HPA for the definition for guidance. However, there are products that are not within the definition that may still be subjected to other regulations. This includes Other Product Categories under the HPA, or under other legislations (such as the Radiation Protection Act, the Consumer Protection/Fair Trading Act, etc.).
As a recap, the definition of an MD is: 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
• Diagnosis, prevention, monitoring, treatment or alleviate of disease;
• Diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;
• Investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;
• Supporting or sustaining life;
• Control of contraception;
• Disinfection of medical devices; or
• 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.
MDs may also refer to the following articles:
• Any implant for the modification or fixation of any body part;
• Any injectable dermal filler or mucous membrane filler
• Any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means
In order to correctly identify if a product is a MD, its intended use must be considered, as well as its design and presentation. In addition, the primary mode of action of the product must also be taken into account.
The full list of classification, complete with detailed examples, can be consulted in their guidance document. HSA hopes this move will help to streamline the product registration process in Singapore on a preliminary level.