On January 15, 2025, the Medical Device Authority (MDA) will begin implementing compounding of offenses under the Medical Device Act 2012 (Act 737). This enforcement is based on the authority granted under Section 71 of Act 737 and the Medical Device (Compounding of Offenses) Regulations 2024, which were officially gazetted last year.
Key Highlights
Objective of the Compounding Regulations
The introduction of these regulations reinforces MDA’s commitment to:
- Upholding the integrity of Malaysia’s medical device regulatory framework.
- Ensuring all manufactured, imported, and marketed medical devices meet stringent safety and quality standards.
- Safeguarding public health by ensuring compliance with medical device regulations.
- Strengthening enforcement mechanisms to deter non-compliance within the industry.
Offenses Subject to Compounding
Under Act 737, the following offenses are eligible for compounding:
- Subsection 19(2)
- Subsection 27(2)
- Subsection 31(2)
- Subsection 40(2)
- Subsection 43(6)
- Subsection 45(5)
- Subsection 46(3)
- Subsection 65(3)
- Medical Device Regulations 2012 [P.U. (A) 500/2012]
- Medical Device Regulations (Duties and Obligations of Establishments) 2019 [P.U. (A) 318/2019]
Payment and Compliance Requirements
Establishments found in violation of the Act must settle the compound payment within 14 days from the date of issuance. Failure to comply within the stipulated timeframe will result in legal action by the MDA.
With the enforcement of these compounding regulations, medical device establishments in manufacturing, importation, and distribution must ensure strict adherence to regulatory requirements to avoid penalties and legal consequences.
With the enforcement of these compounding regulations, medical device establishments in manufacturing, importation, and distribution must ensure strict adherence to regulatory requirements to avoid penalties and legal consequences.
Next Steps
For more details on compoundable offenses and compounding procedures, please refer to the official Medical Device (Compounding of Offenses) Regulations 2024, available for download at:
https://portal.mda.gov.my/index.php/doc-list/legislation.
If you have any inquiries regarding this regulation, please contact our team at sales@andamanmed.com or click the button below.
https://portal.mda.gov.my/index.php/doc-list/legislation.
If you have any inquiries regarding this regulation, please contact our team at sales@andamanmed.com or click the button below.
