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Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device

This guideline is produced to assist the manufacturer and AR (authorized representative) in submitting the registration on refurbished medical devices under Section 5(1) of Medical Device Act 2012 (Act 737) as it requires a medical device to be registered under the Act prior to being imported, exported, or placed on the market.

Refurbished Medical Device

A medical device of which the whole or any part thereof has been rebuilt, whether or not using parts from one or more used medical devices of that same kind, so as to create a medical device that can be used for the purpose originally intended by the product owner of the original medical device, and which may have had the following work carried out on it:

(i) stripping into component parts or subassemblies;

(ii) checking their suitability for reuse;

(iii) replacement of components/sub-assemblies not suitable for reuse;

(iv) assembly of the reclaimed and/or replacement components/sub-assemblies;

(v) testing of the assembled device against either original or revised release criteria; or

(vi) identifying an assembled medical device as a refurbished medical device.

In accordance with this recommendation, refurbished medical equipment must be registered via the Medical Device Centralised Online Application System (MeDC@St).

The manufacturer or the authorised representative is in charge of registering a refurbished medical device.

Click this LINK to know more about Requirements for registration, Conducting Conformity assessment, Application procedure, Evaluation Timeline etc.


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