The Medical Device Authority (MDA) is a legal entity that regulates medical device registration in Malaysia. The definition of a medical device according to MDA/Act 737 is 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 the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease, reduction, or compensation for an injury.

Medical devices must be registered with the Medical Device Authority (MDA) before importing, exporting or marketing medical devices in Malaysia, whether produced domestically or abroad. Medical Device Centralized Online Application System (MeDC@St2.0) or commonly known as Medcast.‎+ is an online application system for making applications for registration of medical devices in Malaysia. To get an application, companies need to first create an account at MeDC@St2.0. Companies must have an Establishment License to register medical devices in Malaysia. To obtain an Incorporation License, a company must be registered locally in Malaysia with the Companies Commission (SSM).

MeDC@St is‎‎ an acronym for Medical Device Centralized Online Application System, an online system for managing various applications created for MDA. MeDC@St was launched in July 2013 and upgraded in January 2019 to MeDC@St 2.0. On February 1, 2022, MDA introduced another improvement to the online application system, namely the latest version of MeDC@St2.0+, which will incorporate additional features such as the Change Notification module, Device Study sub-module, Clinical Research Use sub-module, Demonstration for Marketing Notification module dan Payment module

The Classification of Medical Devices in Malaysia is based on the market of risks associated with the vulnerability of the human body, technical design and manufacture of medical devices, regulations on the classification of medical devices based on their intended use, duration of use (temporary, short-term and long-term), and parts of the human body (non-permanent). -invasive or invasive in relation to body orifices, surgical invasive interventions, the central circulatory system, and the central nervous system).

There are several reasons that can affect the classification of medical devices, such as the duration of the device's contact with the body, its intended action on the human body, local versus systemic effects, whether the device is in contact with injured skin, the ability to reuse it, whether the device delivers drugs or energy to the patient, whether the device is intended to have a biological effect on the body, and whether the device is for diagnosis or treatment.

The process of classifying medical devices in Malaysia follows the standard of the ASEAN Medical Device Directive (AMDD), namely medical devices are classified into 4 based on risk, as below:

• Class A (Low risk) includes medical devices that have a low risk, such as bandage, tongue depressor, walking aids, oxygen mask, medical mask, examination light, dan simple surgical instrument.

• Class B (Low – moderate risk) are medical devices that have a low to moderate risk, such as catheter, disposable hypodermic needles, disposable perfusion sets, surgical dressing dan scalp vein set.

• Class C (Medium – high risk) includes medical devices that have a moderate to high risk, such as deep wound dressing, defibrillator, radiological therapy equipment, ventilator, lung ventilator, blood oxygenator, contact lens dan blood bag.

• Class D (High Risk) is a medical device that has a high risk, such as heart valves, inter-uterine contraceptive device, pacemakers and their leads, implantable defibrillators, implantable infusion pump, neurological catheters dan stent.

Classification regulations for IVD medical devices are based on their intended use, the technical/scientific/medical expertise of the intended users, The importance of information for diagnosis (single determinant or one of several), taking into account the natural history of the disease or disorder, including showing signs and symptoms that may guide clinicians and the impact of outcomes (true or false) on individual and/or public health.

IVD medical devices are classified into 4 classes: A, B, C, and D. Based on the risks associated with the vulnerability of the human body, the technical design and manufacture of medical devices, as below:

• Class A (Low risk) is a medical device that has a low risk, such as: Clinical Chemistry Analyzer, Prepared Selective Culture Media.

• Class B (Low – moderate risk) is a medical device that has a low to moderate risk, such as: Vitamin B12, Pregnancy Self-Testing, Anti-Nuclear Antibody, and Urine Test Strips.

• Class C (Medium - high) is a medical device that has a moderate to high risk, such as: Blood Glucose Self-Testing, HLA Typing. PSA Screening, Rubella.

• Class D (High) is a medical device that has a high risk, such as: HIV Blood Donor Screening, HIV Blood Diagnostic.

In registering medical devices and IVD medical devices, groupings can be made based on The Medical Device Act 2012 (Act 737), with 3 basic rules for determining the grouping of medical devices, namely one generic ownership name, one manufacturer, and one intended general purpose.

Medical devices to be registered can be grouped into one category as follows:

• Single

• Family

• System

• Set

And for IVD medical devices to be registered, they can be grouped into one category as follows:

• Single

• Family

• System

• IVD Test Kit

• IVD Cluster

Source:

• In-Vitro Diaganostic Device – Medical Device Authority (MDA)

• Guidance Document – Medical Device Authority (MDA)

• General Medical Device – Medical Device Authority (MDA)

• LAUNCHING OF THE NEW MeDC@St 2.0+ – Medical Device Authority (MDA)