NEW RELEASE GUIDELINE DOCUMENT MDA/GL/10: GUIDELINE DOCUMENT ON HOW TO SUBMIT AN APPLICATION FOR REGISTRATION OF A REFURBISHED MEDICAL DEVICE
This guideline document was prepared by the Medical Device Authority (MDA) to help the industry and stakeholders in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.
This guideline document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following;
a) Medical Device Act 2012 (Act 737); and
b) Medical Device Regulations 2012.
To view the guideline document CLICK HERE
Updated: 11 January 2023