Government has invited proposals from all NABL accredited laboratories in the country which are having capacity and capability for testing and evaluation of the medical device including in vitro diagnostics (IVDs) to be notified as central medical device testing lab in accordance with the new Medical Device Rules (MDR) 2017 which came into effect from January 1, 2018.

According to the government notification dated 31st January, 2017, all the testing labs may get registered with Central Drugs Standard Control Organization (CDSCO) and also inform details about their activities.

Similarly those labs, who are willing to get designated as medical device testing laboratories under said rules shall communicate their details about which medical device or IVDs can be tested at their laboratories along with persons involved in the testing.

This information is being sought in light of MDR-2017 and those labs which are found suitable may officially be designated as central medical device testing lab for the purpose of testing and evaluation.
 
In this regard, it is also required to get such laboratories registered under Rules 81 to Rule 86 of Chapter X of MDR-2017, if they are involved in medical device and IVDs testing on behalf of the stakeholder.

Further, Rule-19 in chapter-III, of Medical Device Rule, 2017, prescribes that the Central Government may, by notification, may also designate any laboratory having facilities for carrying out test and evaluation of medical devices including in vitro diagnostics medical device, as central medical devices testing laboratory with the provision that no medical device testing laboratory, shall be so designated unless it has been duly accredited by the National Accreditation Board for testing and calibration laboratories (i.e. NABL).

The proposal shall include covering letter mentioning the name and address of testing institute, hospital, diagnostic lab on the letter head, duly sign and stamped by the director or head of organisation, self attested copy of authorization letter to the person issued by the director/company/secretary/partner/owner, valid copy of NABL Certificate along with the annexure, copy of testing protocol and testing method for each of the testing parameter, list of equipments/apparatus/lnstruments/analyser along with the calibration status and manufacturer details, number of sample required for each testing along with proposed testing fee, time duration for the testing report, name and designation of the competent person for each of testing including his/her qualification, experience in relevant testing, Expression of Interest (EOI) - that you would like to be designated as medical device or in vitro diagnostic testing laboratory.