How to undertake classified to medical devices?

Judge Jim Gray Part 3: Medical Marijuana

How to undertake classified to medical devices?

" medical devices monitors regulation " (the State Council makes the 276th) : The country executes classified management to medical devices.

The first kind is to point to, through convention management enough assures the medical devices of its security, effectiveness.

The 2nd kind is to point to, to its security, effectiveness ought to try pilot medical devices.

The 3rd kind is to point to, embedded human body; Use at support, maintain life; Have potential risk to human body, to its security, effectiveness must strict pilot medical devices.

Zhongshan university is accessary Qi Shaohai of vice director of division of section chief of division of equipment of the first hospital, burn:

The angle of the person that use from equipment looks, medical devices can induce roughly again classification. For example, the examination diagnoses an instrument, mix in radiative division examine division own very large share, plus the custody of other administrative or technical offices appearance, anaesthetic machine is waited a moment and a series of form a complete set. Such looking, seem not quite difficult. However, the brand that should understand deep and masters a product, function, clinical fixed position reachs the difference between its, it is very intimate knowledge however.

" Medical Protection is implemental " : From clinical angle, medical devices can classify for:

(one) large facility kind

1,
CT

2,
MRI

3,
PET/CT

4,
DSA

(2) examine analytic equipment kind

1,
Biochemical analyzer

2,
Corpuscular tally

3,
Microscope of double canister biology

4,
Urinalysis appearance

5,
Enzymatic award ceremony

6,
Wash trigger

7,
Biology safety ark

8,
Exceed clean workbench

(3) diagnostic equipment kind

1,
Ultrasonic diagnoses appearance

2,
Smooth machine of of all kinds X

3,
Electrocardiogram machine

(4) equipment of serious illness emergency treatment kind

1,
Lung ventilator

2,
Anaesthetic machine

3,
Tutelar appearance