Singapore legislation

Schedule 5

of Health Products (Medical Devices) Regulations 2010

Schedule 5

Implantable Medical Devices

FIFTH SCHEDULERegulation 40(1)Implantable Medical Devices

1. Heart valve.

2. Annuloplasty ring.

3. The following active implantable medical device systems:

(a)

all models of implantable pacemakers and leads;

(b)

all models of implantable defibrillators and leads;

(c)

artificial heart;

(d)

implantable ventricular support system; and

(e)

implantable drug infusion system.

4. All orthopaedic joint replacement implants.

5. The following neurological implantable devices:5.—

(a)

neurological stents;

(b)

neurological implants;

(c)

implantable neurostimulation devices and leads.[S 318/2018 wef 01/06/2018]6. Breast implant.[S 318/2018 wef 01/06/2018]7. Intraocular lens.[S 318/2018 wef 01/06/2018]8. Cardiovascular stent in contact with the central circulatory system, including the following major internal blood vessels:

(a)

aorta abdominalis;

(b)

aorta ascendens;

(c)

aorta descendens to the bifurcatio aortae;

(d)

aorta thoracica;

(e)

arcus aorta;

(f)

arteria carotis communis;

(g)

arteria carotis externa;

(h)

arteria carotis interna;

(i)

arteriae cerebrates;

(j)

arteriae coronariae;

(k)

arteriae pulmonales;

(l)

ilica communis;

(m)

truncus brachiocephalicus;

(n)

venae cava inferior;

(o)

venae cava superior;

(p)

venae cordis;

(q)

venae pulmonales.[S 318/2018 wef 01/06/2018]

Read in full context — Health Products (Medical Devices) Regulations 2010 →