Medical Device Product Registration

According to Medical Device Act 2012, medical device is defined as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

  1. Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of:
  2. diagnosis, prevention, monitoring, treatment or alleviation of disease;
  3. diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
  4. investigation, replacement, modification or support of the anatomy of a physiological process;
  5. supporting or sustaining life
  6. control of conception
  7. disinfection of medical devices
  8. providing information for medical or diagnostic purposes by means of in vitro 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; and

  • any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a Medical Device by other published in the Gazette.

According to Sec 5 (1) of Medical Device Act 2012, no medical device shall be imported, exported or placed in the market unless it is registered under the act. In addition, Sec 15 (1) of Medical Device Act 2012 stated that no establishment shall import, export or placed in the market a registered medical device unless it holds on establishment license granted under this act. Hence, it is essential to register the medical device product before a company can sell it in the market.

In JasCal Management & Consultancy, we are providing the service to assist our clients in applying the establishment license and registering the medical device product.