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