Effective date for medical devices extended

MINISTRY OF HEALTH AND FAMILY WELFARE has issued two notifications vide which the effective date for medical devices has been extended

1452
Gazette of India
2 min. read

Effective date for medical devices extended as MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) has issued notification No. S.O. 4671 (E ) dated 27-12-2019 vide which the previous notification No. S.O. 5980 (E ) dated 03-12-2018 has been amended

Contents of Notification No. S.O. 5980 (E) is as under:

In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings for the purposes referred to in the said sub-clause as drugs with effect from the 1st day of January, 2020, namely:-

(i) Nebulizer;
(ii) Blood Pressure Monitoring Devices;
(iii) Digital Thermometer; and
(iv) Glucometer.


To download the notification, click here


Contents of Notification No. S.O. 4671(E) is as under:

In pursuance sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby amends the notification of the Government of India, Ministry of Health and Family Welfare (Department of Health and Family Welfare) No. S.O. 5980(E), dated the 3rd December, 2018 published in PART II, Section 3, Sub-section (ii) of the Gazette of India,
Extraordinary, namely,

In the said notification, for the words and figures “the 1st day of January, 2020” the words and figures “the 1st day of January, 2021” shall be substituted.


To download the notification, click here


Effective date for medical devices extended as MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) has issued notification No. S.O. 4672 (E ) dated 27-12-2019 vide which the previous notification No. S.O. 775 (E ) dated 08-02-2019 has been amended

Content of Notification No. S.O. 775 (E) is as under:

In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings for the purposes referred to in the said sub-clause as drugs with effect from the 1st day of April, 2020, namely:-

(i) All implantable medical devices;
(ii) CT scan Equipment;
(iii) MRI Equipment;
(iv) Defibrillators;
(v) Dialysis Machine;
(vi) PET Equipment;
(vii) X-Ray Machine; and
(viii) Bone marrow cell separator.


To download the notification, click here


Content of Notification No. S.O. 4672(E) is as under:

In pursuance sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby amends the notification of the Government of India, Ministry of Health and Family Welfare (Department of Health and Family Welfare) No. S.O. 5980(E), dated the 3rd December, 2018 published in PART II, Section 3, Sub-section (ii) of the Gazette of India,
Extraordinary, namely,

In the said notification, for the words and figures “the 1st day of January, 2020” the words and figures “the 1st day of April, 2021” shall be substituted.


To download the notification, click here


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