Mandatory Registration of Medical Devices The Medical Device Act 2012 was passed in February by Mal

Mandatory Registration of Medical Devices
The Medical Device Act 2012 was passed in February by Malaysia’s Ministry of Health, requiring all medical devices imported and/or locally manufactured in Malaysia to be registered with the ministry.

Before this act, Malaysia’s Ministry of Health encouraged medical device establishments to voluntarily register their medical devices through an electronic registration system called MeDVER. This voluntary registration scheme was meant as a transitory step before medical device regulations were fully imposed. However, being registered under MeDVER did not mean that the Ministry of Health had
necessarily approved the product.

Now, the Medical Device Act 2012 will require all medical devices imported, exported, or sold in Malaysia to be registered with and approved by the Ministry of Health. Medical device companies will have a two-year transition period to familiarize themselves with the product registration process and make necessary preparations to get their products approved. Thus, the act will become fully enforced by 2014. Approved medical devices will be classified according to the product’s risk levels and intended use. The least risky products will be classified as Class A, and the most risky products will be classified as Class D.