1. 99.999999% of software is not equivalent to "doing surgery" so doesn't need gatekeeping. I work on free, open-source PDF reader SumatraPDF. What kind of authorization should I get and from whom to ship this software to people?

2. pacemakers and other medical devices have to get approval from the government. So that's covered.

medical CRM software is covered by medical privacy laws which does what you say you want (criminalizes "bad" software) but in reality is a giant set of rules, many idiotic, that make health care more expensive for no benefit at all.