The Central Standard Control Organisation (CDSCO) on May 29, 2024, notified regarding the testing and evaluation of Medical Devices (MD)/In vitro diagnostics (IVDs) by Medical Devices Testing Laboratories in the country.
The following has been stated namely: -
• It states that the government has granted registration of a Laboratory for carrying out the Test or Evaluation of a Medical Device on behalf of a manufacturer, to strengthen the testing facility in the country.
• It states that the implementation of MDR 2017 with effect from January 01, 2018, and the Drug Rules 1945, shall no longer apply to MDs/IVDs.
• It states that for the MDs which has BIS standards available, the testing of such devices shall not be carried out as per BIS standards.
• It states that the samples of the medical devices shall comply with the BIS standards for their quality, and performance, and accordingly the medical devices shall be tested with respect to the requirements as prescribed in the BIS standards.
• It states that if no BIS standards are available, then only other standards as mentioned in Rule 7 of the MDR shall be applied.
[Notification no. - MED/48/2024-eoffice]
