Medical Device Regulatory Requirements in Malaysia
| Regulatory Authority |
Malaysian Medical Device Authority (MDA) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
A,B,C,D |
| Medical Device Regulations |
Medical Device Regulation 2012
| Click Here
|
| IVD Classification |
A,B,C,D |
| Registration Process |
Medical Device Registration Information
| Click Here
|
| Registration Timeline |
Class A takes 1 to 2 months and other classes take 3 to 7 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Malaysia And/or English Language |
| Additional Information |
No establishment shall import, export, or place in the market any registered medical device unless it holds an establishment license granted under the Act. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025