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Malaysia - Medical Device Registration
Medical Device Registration in Malaysia
For foreign medical device manufacturers, Malaysia is one of Southeast Asia's most robust and dynamic markets. The Malaysian Medical Device Authority (MDA) is the authority governing the placing on the market of medical device. To get your product approved for sale in Malaysia, you must first register with the MDA. TUV Rheinland can help you access Malaysia market for your medical device. Contact our expert now for more details!
| Technical aspects | Safety |
| Market surveillance | Yes |
| Obligation | Mandatory |
| Factory inspection | No |
| Sample testing | No |
| Validity |
Licenses are valid for five years. |
Product Scope
All products that meet the definition of "medical device" shall be registered prior to placement into the market by the MDA.
Examples: Contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines.
As of April 2016, Class A devices are exempted from conformity assessment in Malaysia. However, they must be registered with the MDA, and must continue to meet a number of other requirements, including post-market obligations.
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