What is a borderline medical device in ASEAN terms and published list for your reference?

This is a rather short article to share about the definition and published list of borderline medical device that might be supportive for your regulatory intelligence exercise.

A borderline medical device might have some features of a medical device which is to diagnose ,treat or prevent a symptoms or diseases  and possibly  contain  agent or even mode of action which achieve its intended function via   pharmacological, immunological or metabolic means. A common product would be that of a wart product which is to get rid of warts through cryotherapy.  The mode of action of the wart product could put it at risk of being a drug product rather than a medical device if it contains a caustic agent that destroy warts by chemical coagulation of protein . Hence it is useful for us to know  the rule defined by the authority in order for us to classify the product appropriately as medical device.

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Definition of medical device in accordance to ASEAN Medical Device Directive:

A “medical device” shall mean any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article: (i) intended by the product owner to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: (a) diagnosis, prevention, monitoring, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (c) investigation, replacement, modification, or support of the anatomy or of a physiological process; (d) supporting or sustaining life; (e) control of conception; (f) disinfection of medical devices; and (g) providing information for medical or diagnostic purposes by means of invitro examination of specimens derived from the human body; 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.

Definition of borderline medical device as agreed by the ASEAN Medical Device Committee (AMDC):

In accordance to published guidance document by Medical Device Authority of Malaysia,

Borderline medical devices are devices that are difficult to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal protective equipment. These products are called borderline products until their status of medical device or non-medical device .

The list of borderline medical devices is updated yearly based on decision by the ASEAN Medical Device Committee (AMDC).

Useful references for you to check:

  1. ASEAN Medical Device Directives
  3. List of Harmonized Classification of Devices


If your product does is not listed within the list, you can always write in to us to get a confirmatory response regarding the classification with local authority.


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