Malaysia Introduces Registration for OEMs

Malaysia’s Ministry of Health and Medical Device Authority will start to enforce licenses for original equipment manufacturers for devices sold in Malaysia.

In the past, OEMs were allowed to sell their products to other companies without a license. The regulator said no device may be imported, exported or placed on the market unless it is registered and provides evidence of establishment license.

Companies may not import, export or place devices in the market unless they hold an establishment license.

The ministry is changing its policy to facilitate OEMs obtaining licenses to market their products globally. Previously OEMs were not regulated under the country’s Medical Devices Act because they didn’t fit the definition of establishments or authorized representatives.