This guidance document is intended to protect the health and safety of patients, users, and others by requiring medical device manufacturers to follow specific procedures during design, manufacturing, and marketing. It also intends to classify medical devices in accordance with Section 2 of the Medical Device Act of 2012 (Act 737) and the 2012 Medical Device Regulations.

There are a few terms which have been added in this second edition of the guidance document, including the central circulatory system, central nervous system, cleaning, continuous use, disinfection, surgically invasive medical devices, and radiopharmaceuticals.

In the second edition guidance document, MDA stated that if an establishment and a conformity assessment body disagree on the classification of a medical device, the establishment may request in writing to the Authority to resolve the matter within 30 days from the date of the dispute. The Authority shall ultimately decide on the proper classification of the requested medical device. For more information regarding the guidance, you can click the following link here.

In conclusion, the update of the guidance provides a clearer guidance to the establishments for appropriately classifying the medical devices.

Guidance on The Rules of Classification for General Medical Devices