Draft Protocols Aim to Streamline IVD Licensure Under Medical Devices Rules 2017
The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have collaboratively released draft standard evaluation protocols to assist In-Vitro Diagnostics (IVD) manufacturers and testing laboratories in India. These protocols are a significant step toward streamlining the licensing process for IVDs under the Medical Devices Rules 2017.
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Detailed Evaluation Protocols for Quality and Performance Assessment
According to the Medical Devices Rules 2017, IVD licensure necessitates a thorough performance evaluation to ensure the quality and efficacy of the diagnostics. In response, ICMR and CDSCO have developed these draft protocols to standardize the evaluation process, facilitating seamless regulatory approvals for IVDs.
IVD Evaluation Protocols Released for Public Review
The draft protocols are now available for public consultation, inviting comments and suggestions from stakeholders. The feedback window remains open until February 15, 2025, allowing manufacturers, researchers, and other stakeholders to submit their input to ivdevaluation@gmail.com using the specified format.
List of Protocols Developed for Specific IVD Tests
The released draft protocols cover performance and field evaluations for diagnostic tests targeting diseases like Chikungunya, Dengue, and Zika virus. The protocols include:
- Chikungunya IgM ELISA
- Chikungunya IgM RDT
- Chikungunya real-time PCR
- Dengue NS1 RDT
- Field evaluation for Dengue NS1 RDT
- Dengue NS1 ELISA
- Field evaluation for Dengue NS1 ELISA
- Dengue IgM RDT
- Dengue IgM ELISA
- Dengue NS1/IgM combo RDT
- Field evaluation for Dengue NS1/IgM combo RDT
- Dengue real-time PCR
- Field evaluation for Dengue real-time PCR
- Zika virus real-time PCR
Stakeholders Urged to Share Feedback Before February 15, 2025
The CDSCO has emphasized that this consultation period is a critical opportunity for stakeholders to contribute to the finalization of the protocols. Once finalized, only minimal changes will be possible.
Next Steps: Review and Clearance
Following the public consultation period, all received comments will be thoroughly reviewed by ICMR and CDSCO. The finalized protocols are expected to be cleared for implementation, paving the way for a more efficient and standardized IVD licensing framework in India.
Importance of Standardized Protocols in IVD Manufacturing
This initiative underscores the importance of detailed and standardized evaluation protocols in maintaining the quality and reliability of diagnostic tools, which are critical for public health management and disease control in India.
