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.
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- 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
References:
MDA Product Classification