DEFINITION OF MEDICAL DEVICE

The term medical device includes:

• any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used,  alone  or  in  combination,  for human  beings  for  the  purpose  of—
• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

• investigation, replacement or modification, or support of the anatomy or of a physiological process;

• support or sustaining life;
• control of conception;
• disinfection of medical device; or

• providing information for medical or diagnostic purpose 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 that 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 order published in the Gazette

DEFINITION OF DRUG

Under the CDCR 1984, Regulation 2: “Product” means:

• a drug¹ in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose²; or
• a drug¹ to be used as an ingredient of a preparation for a medicinal purpose².

Under Sales of Drug Act 1952, Section 2:

• “drug” includes any substance, product or article intended to be used or capable, or purported or claimed to be capable, of being used on humans or any animal, whether internally or externally, for a medicinal purpose.
• “medicinal purpose” means any of the following purposes:
• alleviating, treating, curing or preventing a disease or a pathological condition or symptoms of a disease;
• diagnosing a disease or ascertaining the existence, degree or extent of a physiological or pathological condition;
• contraception;
• inducing anaesthesia;
• maintaining, modifying, preventing, restoring, or interfering with, the normal operation of a physiological function;
• controlling body weight;
• general maintenance or promotion of health or well being

DEFINITION OF COMBINATION PRODUCT

The term combination product includes:

• A product comprised of two or more regulated components, i.e., drug/device, biological/device, or drug/device/biological, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
• Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products.

Products that are excluded from the term combination products and will be regulated separately:

• A drug, device, or biological product packaged separately that according to its investigational plan or proposed labelling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product labelling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or
• Any investigational drug or device packaged separately that according to its proposed labelling is use only with another individually specified investigational drug, device, or cosmetic product where both are required to achieve the intended use, indication or effect.
• Convenience pack products (example: first aid kit consist of medical device and non-scheduled poison products)

Appendix 1 shows an illustrative table of the example of Drug-Medical Device/Medical Device-Drug Combination Product classification

Prior to registration, an applicant may apply classification application to NPRA through product classification form (NPRA 300.1) which is available at http://npra.gov.my