List of Notified Medical Devices - cdsco

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('ardiac SteJJls. Drug Eluting Slents. " (l(l(UCl f. V Cannulae. 13cillC Cements. Heart Valves. Scalp Vein Set. Orthopae
The Ministry of Health and Family Welfare, Govt. of India under following Gazette notifications has notified Ihef()Howing devices to be considered as drugs under Section 3, Clause (b) . Sub clause (iv) of the Drugs and Cosmetics Act: -

~at~i;i'"

Disposable

IIypodennic

Syringes

Notification Nnmber GSR 365 (E)

Disposable

IIypodermic

Needles

(-'SR ~6'5 l-'F') 1.. .).

17-03-1989

Disposable

Perfusion

GSH

17-03-1989

In vitro Di,lgnostic

Sets

Devices for HIV,

365 (E)

notification 17-03-19WJ

GSR 601(E)

27-08-2002

S,O, 1468 (l')

06-10-2U05

HBsAg and [ICV ('ardiac

SteJJls

Drug Eluting Slents "

(l(l(UCl

S.O. 1468 eE)

06-10-2005

S.0.1468(E)

06-1 (}-2005

S.O. 1468 (E)

06-10-2005

f. V Cannulae

S.O. 1468 (E)

06-10-200::'

13cillC Cements

S.(). 1468 (E)

06-! 0-200."

Heart Valves

S.O. 1468 (E)

06-10-2005

Scalp Vein Set

S.O, 1468 (1-:)

06-10-2005

Orthopaedic

S.O. 1468 (E)

06-10-:;005

S.O. 1468 (E)

06-10-2005

I

Implants

Prosthetic

Replacements

Note: Further, the following products are regulated as 'Drugs' Cosmdics Act & Rules there under: -

un~cr Drugs &

L Blood Grouping Sera 2. Ligatures, Sutures and Staplers 3. 4. 5. 6.

Intra Uterine Devices C:ondoms '1ubal Rings SurgicalDressings

(Cu-T)

7. Umbilicalfapcs 8.

BloodlBlood

Component

Bags ~.

U~~or~_W\{) (Dr. S. Eswara Reddy) Asst. Drugs Controller (1)

I