The Central Drugs Standard Control Organization (CDSCO) has released an updated list of laboratories authorized to conduct Performance Evaluation of In Vitro Diagnostic (IVD) Medical Devices.
The notification was issued on 29 June 2026 and replaces the previous version of the approved laboratory list. The update is available under the Medical Device & Diagnostics section of the CDSCO website.
This update is important for manufacturers, importers, and regulatory professionals involved in the development and registration of IVD medical devices in India. Selecting a laboratory recognized by CDSCO is an essential step in generating acceptable performance evaluation data for regulatory submissions.
Why is Performance Evaluation Important?
Performance evaluation is carried out to demonstrate that an IVD medical device performs as intended and produces reliable, accurate, and reproducible results. Depending on the product category and risk classification, CDSCO requires performance evaluation data as part of the technical documentation submitted for manufacturing or import approval under the Medical Devices Rules, 2017.
Using a laboratory that has been recognized by CDSCO helps ensure that the generated evidence meets regulatory expectations and supports a smoother review process.
What Does the Updated List Include?
The revised notification identifies laboratories authorized to conduct performance evaluation for a broad range of IVD categories. These include, among others:
- HIV
- Hepatitis B (HBV)
- Hepatitis C (HCV)
- Tuberculosis (TB)
- Malaria
- Dengue
- Chikungunya
- Influenza
- Typhoid
- Syphilis (Treponema pallidum)
- Blood Grouping and Tissue Typing
- Cancer Biomarkers
- Human Papillomavirus (HPV)
- Rubella and Cytomegalovirus (CMV)
- Pneumonia Pathogens
- Methicillin-Resistant Staphylococcus aureus (MRSA)
- Enterovirus
- SARS-CoV-2
- Other notified IVD categories
The document also provides the corresponding approved laboratories along with their contact details and nodal officers for each diagnostic category.
Who Should Review This Update?
This notification is particularly relevant for:
- IVD manufacturers developing new diagnostic products
- Importers planning CDSCO registration
- Regulatory Affairs professionals
- Quality and Compliance teams
- Product development teams
- Clinical and Performance Evaluation teams
- Indian Authorized Representatives supporting overseas manufacturers
Organizations planning new product registrations should verify whether their selected testing laboratory continues to appear in the updated CDSCO list before initiating performance evaluation studies.
What Does This Mean for Manufacturers?
Using the latest approved laboratory list can help manufacturers:
- Select an appropriate CDSCO-recognized laboratory for their product category.
- Avoid delays caused by using laboratories that are no longer listed for a specific evaluation.
- Ensure performance evaluation reports are generated from recognized testing facilities.
- Support smoother regulatory submissions for manufacturing or import licenses.
Although the update primarily revises the list of approved laboratories, it also serves as a reminder for manufacturers to periodically review regulatory notifications and ensure their compliance strategy remains aligned with current CDSCO requirements.
Official CDSCO Notification
The complete notification can be accessed through the official CDSCO website.
Official PDF:
For additional medical device and IVD guidance documents, stakeholders can also visit the CDSCO Medical Device & Diagnostics section.
Conclusion
The updated list of laboratories published by CDSCO is an important reference document for organizations involved in the development, evaluation, and regulatory approval of IVD medical devices in India. Referring to the latest approved laboratory list before planning performance evaluation studies can help avoid unnecessary delays and support regulatory compliance.
At MedOrdyn Solutions, we regularly monitor regulatory developments from CDSCO and global regulatory authorities to help medical device and IVD manufacturers stay informed. Follow our blog for practical updates, regulatory insights, and guidance on medical device compliance and market access.
