Medical Device Product Classification Guidance for Singapore
New guidance on classifying products as medical devices has been issued by the Health Sciences Authority (HSA), Singapore. The publication of the final document entitled “Medical Devices Product Classification Guide” at the end of November 2021 follows a stakeholder consultation earlier in the year and incorporates additional clarifications on product types as per the feedback received.
Firstly, the guidance document reminds registrants of the definition of a medical device as defined in the First Schedule of the Health Products Act (HPA). It is important to remember that a product may be classified as a medical device in other jurisdictions but not so in Singapore and vice versa. Therefore, the definition should always be referred to (see below).
The guidance document also assists by clarifying the classification of some challenging products. The following product types are specifically discussed in the guideline:
- Products with medical-related purposes
- General-purpose products
- Assistive Technology products
- Products for sports/physical fitness/general health
- Personal protective equipment.
In addition, the document highlights the importance of being aware that health products which do not fall under medical device regulatory control could still be subject to other product categories’ regulatory controls under the Health Products Act and/or other legislation.
Singapore HSA definition of a medical device
A health product is considered a medical device if the intended purpose and primary mode of action fit the definition of the medical device below:
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
- diagnosis, prevention, monitoring, treatment, or alleviate of disease;
- diagnosis, monitoring, treatment or alleviation of, or compensation for an injury;
- the 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 through 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
b) 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.
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