Medical devices are subject to strict general controls and procedural regulations. The development and use of standards is vital to ensuring the safety and efficacy of medical devices.
Please refer to link below for the list of applicable standards for Medical devices released by BIS:
Applicable Standard (BIS)
CDSCO has listed Medical Device Testing Laboratories to carry out test or evaluation of a medical device and for conducting Performance Evaluation of In-Vitro Diagnostic Medical Device.
Testing Centres (Medical Device)
Testing Centres (IVD)
Clinical studies play a vital role in determining safety & effectiveness of medical devices. ICMR-INTENT network serves as pan-India network of institutes with proven excellence in clinical research.
Clinical Investigation/Clinical Performance Evaluation Centres
The “Scheme for Facilitating Startups Intellectual Property Protection (SIPP)” scheme provides start-ups with facilitators for filing and processing their applications for patents, designs and trademarks. The professional charges of the facilitators are reimbursed by the CGPDTM office in accordance with the provisions of the SIPP Scheme.
Please refer to link below for the list of IP facilitators:
IP Facilitators