The following sections were updated on the second edition:

  • I. Preamble, Glossary
  • II. Revision on the Section 4
    • Added diagram of HIP System: Hip implant systems with components available in various lengths can be grouped as a FAMILY of SYSTEMs.

    • Removed the detail and example of IVD test kit and cluster from the General Principles of Grouping for medical device registration.
    • Added Special grouping for In Vitro Fertilisation (IVF) Medical Device:
      • The process of removing eggs (ova) from a woman's ovary is known as in vitro fertilization (IVF). They undergo sperm fertilization in a lab environment, and the fertilized egg (embryo) is then implanted back into the woman's uterus.


III. Revision on the Annexes



MDA Product Classification