What medical equipment needs to meet the requirements?

In Clause 1, Article 1 of Decree 169/2018 / ND-CP amending Decree 36/2016 / ND-CP on management of medical equipment, there are provisions as follows:

Medical equipment are types of implements, instruments, materials, implant materials, reagents and in vitro calibrators, software (software) that simultaneously meet the following requirements:

a) Used alone or in conjunction with the designation of a medical device owner to serve people for one or more of the following purposes:

- Diagnose, prevent, monitor and treat and reduce illness or compensate for injuries and injuries;

- Check, replace, adjust or support anatomy and physiological processes;

- Support or maintain life;

- Control conception;

- Disinfect medical equipment, including chemicals used in the testing process;

- Provide information for the diagnosis, monitoring and treatment through measures to check samples derived from the human body.

b) Not using pharmacological, immunological or metabolic mechanisms in or on human bodies or if using these mechanisms, it is only supportive to achieve the purpose specified at Point a of this Clause.