July 13, 2018
According to rule 19 of the Medical Device Rules 2017, the central government may establish “Central Medical Devices Testing Laboratories” for the purpose of
(a) testing and evaluation of medical devices; or
(b) functioning as an appellate laboratory; or
(c) to carry out any other function as may be specifically assigned to it.
It is also possible that Central Government might designate any laboratory having proper facilities for carrying out test and evaluation of medical devices as “Central Medical Devices Testing Laboratories” for above mentioned purposes. Also it is to be noted that no medical devices testing laboratory, shall be so designated unless it has been duly accredited by the National Accreditation Body.
Therefore, in pursuance of the powers conferred by sub-rule (2) of rule 19 of the Medical Devices Rules, 2017, the Central Government hereby designates the laboratories specified in Table 1 below having facilities for carrying out test and evaluation of medical devices, as Central Medical Device Testing Laboratory for the purposes specified above. These facilities have been duly accredited by the National Accreditation Body of India. The list is given in Table 1 below.
This Order shall come into force on and from the date of its publication in the Official Gazette, which is starting from 4th June 2018 and can be consulted in the following link.
Reference:
S.O. 2237(E)_Notification on Central Medical Device Testing Laboratory under MDR 2017