April 9th, 2018

In light of the new Medical Device Rules 2017, CDSCO/CLA/SLA shall have updated information of laboratories involved in testing of medical device & in vitro diagnostics with respect to their laboratory reports and decision on performance evaluation of products made by stakeholder/regulator.

In line with this proposal, it is also required for laboratories to be registered as stated under Rules 81-86 of Chapter X of MDR 2017, if they are involved in Medical device/IVD's testing on the stakeholder's behalf.

Furthermore, Rule 19 in Chapter III of Medical Device Rule 2017 mandates that the Central Government are authorized to designate any testing laboratory to serve as Central Medical Devices Testing Laboratory for the purposes of carrying out tests and evaluation of Medical Devices, including in vitro diagnostics, with the provision that no Medical Device Testing Laboratory shall be designated unless it has been duly accredited by the National Accreditation Board for testing and calibration laboratories (i.e. NABL)

NABL accredited laboratories may register with CDSCO and notify the latter of the details of their activities. Similarly, those laboratories that intend to be designated as Medical Device Testing Laboratories shall inquire regarding which Medical Device/IVD's can be tested in their laboratories, along with the required qualifications of the personnel involved in the testing. These information are necessary, in light of MDR 2017. Laboratories which are found suitable may be officially designated as Central Medical Device testing laboratories for the purpose of testing and evaluation.


Proposal for Designation of Central Testing Laboratories for Medical Devices and In-Vitro Medical Device