Medical Device Registration

Good Distribution Practice for Medical Devices (GDPMD)

Ensure an establishment's ability to maintain the quality, safety and performance of medical devices

About the Good Distribution Practice for Medical Devices (GDPMD)
The Good Distribution Practice for Medical Devices (GDPMD) applies to all companies carrying out activities, as stated in the Medical Devices Act 2012 (Act 737). The companies involved in the supply chain of medical devices must establish, implement and maintain a quality management system.

The certification ensures an establishment’s ability to maintain the quality, safety and performance of medical devices in its custody. The standard involves parties such as representatives of foreign manufacturers, importers and distributors of medical devices in Malaysia.

Benefits of Good Distribution Practice for Medical Devices (GDPMD)
Medical devices are appropriately managed and controlled throughout the supply chain. Thus, ensuring their safety and performance at the point of use.
Assures stakeholders through certification that the organisation can maintain quality, safety and performance of medical devices while under its custody.
Fulfilment of establishment licensing requirements.

What is considered a medical device in Malaysia?

The term ‘medical device’ covers any product used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability but excludes drugs. This definition of medical device includes in-vitro diagnostics (IVDs).
Any medical device must comply with Section 2 of Act 737 (refer to guidance document MDA/GD/0006) and shall register under the Act before it can be imported, exported or placed in the market.

Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostics.

MALAYSIA MEDICAL DEVICE CLASSIFICATION

The Malaysian Medical Device Authority (MDA) created a classification system based on Medical Device Regulation 2012 which is closely aligned with the ASEAN MDD.

The risk level is dependent on the intended use, effectiveness of risk management techniques applied during design, manufacture and use, its intended user(s), mode of operation, and technologies used.

Products are classified into one of the following, from lowest to highest risk:

Class A
Class B
Class C
Class D
Combination Devices
The following general principles from section 5 apply (page 4):

The classification of the device is based on the risk associated to it at the point of usage (The risk to patients, users, and other persons)
The risk presented by a particular device depends on:
Its intended purpose
The effectiveness of the risk management techniques applied during design, manufacturing, and use its intended user(s)
Its mode of operation technologies.
Factors from section 6 that may affect medical device classification are the following (page 5):

The duration of contact of the device with the body the degree of, and site of, invasiveness into the body, whether the device deliver medicines or energy to the patient, whether the device is intended to have a biological effect on the body intended action on the human body local versus systemic effects, whether the device comes into contact with injured skin and whether for diagnosis or treatment the ability to be re-used or not, combination of devices


IVD CLASSIFICATION RULES
IVDs are categorized separately from other medical devices and are further subdivided into one of the following, from lowest to highest risk:

Class A
Class B
Class C
Class D

Risk is determined by intended use, the expertise of the intended user, the importance of the resulting information of the diagnostic, and the impact of the test results. For example, a pregnancy test is Class B whereas an HIV Blood Test is Class D.

As the risk increases, more documentation may be required. For more details, contact KayV Consulting.