The Ministry of Health and Family Welfare (MoHFW) on June 01, 2023, issued the Medical Devices (Amendment) Rules, 2023 to further amend the Medical Device Rules, 2017.
The following amendments have been stated:
• Rule 3 specifies ‘Definitions’, after sub-rule (zu), the following sub-rule has been inserted namely, -
“(zua) “State Medical Devices Testing Laboratory” means a medical devices laboratory established or designated by the State Government under rule 19(3).”
- In rule 18, in sub-rule (1), after the words “Central Government”, the words “or, as the case may be, the State Government” shall be inserted.
• Rule 18 specifies ‘Medical Device Testing Officer and Medical Device Officer’, in sub-rule (1), after the words “Central Government”, the words “or, as the case may be, the State Government” has been inserted.
• Rule 19 specifies ‘Central medical device testing laboratory’, the words “Central Medical Device Testing Laboratory” has been substituted with “Medical Device Testing Laboratory”.
• Rule 19 specifies ‘Central medical device testing laboratory’, sub-rule (3) has been inserted, namely: —
“(3) (1) The State Government may, by notification, establish State Medical Devices Testing Laboratory for the purpose of, —
(a) testing and evaluation of medical devices; or
(b) to carry out any other function as may be specifically assigned to it.
(2) Without prejudice to sub-rule (3) (1), the State Government may also designate any laboratory having a facility for carrying out test and evaluation of medical devices as a State Medical Devices Testing Laboratory for the purposes specified in sub-rule (3) (1):
Provided that no medical devices testing laboratory shall be so designated unless it has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.”
[Notification No. G.S.R. 409(E)]
