Regulatory Background
MDA has published the 2nd edition of the guidance document on definition of the medical device, MDA/GD/0006.
Definition Clarifications
This updated guidance document provides further clarification on the definition of a medical device, including accessories, components, and spare parts, as shown in the table below:
| Accessory |
An article which is intended specifically by manufacturers to (a) be used together with a medical device to enable that device to be used in accordance with its intended purpose as a medical device; or |
| Component | One of several possibly unequal subdivisions which together constitute the whole medical device to achieve the latter’s intended purpose, which may also be known as part but not medical device in its own right. |
| Spare Part | A spare part refers to a part or material intended to replace an identical or functionally equivalent part of a medical device after it has been placed on the market, for the purposes of restoring or maintaining the original safety, performance, and intended use of the device, without modifying its intended purpose or design. |
Regulatory Significance
The guidance document serves as an important reference for the medical device industry, Conformity Assessment Bodies (CABs), and other relevant stakeholders in determining whether a product falls within the scope of medical device regulation. In addition, this update provides clearer guidance on the classifying products as medical devices By clarifying the definition of medical devices, including their accessories, components, and spare parts. It helps reduce uncertainty in determining whether a product qualifies as a medical device.
With the updated definitions, companies should reassess their product portfolios to confirm whether products fall within the scope of medical device regulation in Malaysia.
Qualtech Consulting Corporation supports manufacturers in product classification, regulatory strategy, and compliance with Medical Device Authority (MDA) requirements.
Contact us to ensure accurate classification and smooth market access in Malaysia.
Reference
Medical Device Guidance Document: Definition of Medical Device (Second Edition)