Drugdu.com expert's response:

I. Indian Registration and Regulatory Requirements

Regulatory Framework: The Indian Drugs and Cosmetics Act and related regulations (such as CDSCO guidelines) serve as the primary regulatory basis for IVD products.

Classification Management: Nipah virus detection reagents are typically classified as high-risk categories and are subject to rigorous review.

Technical Documentation Requirements: Complete technical documentation must be submitted, including product descriptions, performance indicators, test reports, production processes, and quality management system documents. Key information such as detection principles, targets (genes/antigens/antibodies), sample types, and batch release criteria must be provided.

Clinical Trial Requirements: Clinical trials may be required, and corresponding clinical trial data must be submitted to verify the clinical performance and effectiveness of the product.

Quality Management System: A quality management system compliant with ISO 13485 standards must be established, and relevant certification certificates must be submitted.

Import and Sales License: Import and sales approval must be obtained from the Central Drugs Standard Control Organization (CDSCO) of India.

Accelerated Review Mechanism: In the event of an epidemic or public health emergency, the CDSCO may initiate a "Priority/Expedited Review" mechanism to shorten the review time.

II. EU Registration and Regulatory Requirements

Regulatory Framework: The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) serves as the primary regulatory basis for IVD products.

Classification Management: Nipah virus detection reagents are typically classified as medium- to high-risk categories (e.g., Class C or D) and are subject to review by a notified body.

Technical Documentation Requirements: Complete technical documentation must be submitted, including product information, risk analysis, performance evaluation, and clinical evidence. Performance evaluation must cover indicators such as analytical sensitivity, analytical specificity, repeatability, precision, and stability.

Clinical Trial Requirements:

Adequate clinical assessment must be conducted, including the evaluation of clinical data and literature evidence.

The sample size for clinical trials must be determined based on the risk level and intended use, with a general requirement of at least 1,000 cases for Class III in vitro diagnostic reagents.

Quality Management System: A quality management system compliant with IVDR requirements, typically based on ISO 13485 standards, must be established.

UDI Requirements: The implementation of a Unique Device Identification (UDI) system is required to enhance product traceability.

Notified Body Review: Approval from a notified body designated by the EU and CE certification must be obtained before the product can be placed on the market.

III. WHO Registration and Regulatory Requirements

WHO Prequalification (PQ):

It is a comprehensive and systematic evaluation process with a relatively long cycle, typically lasting 12 to 24 months or even longer.

It includes technical documentation review, performance evaluation, production site inspection, and label/instructions for use review.

Emergency Use Listing (EUL):

It is the only "emergency accelerated IVD evaluation pathway" established by the WHO.

It is designed to allow products that have not yet completed all marketing authorizations to be temporarily used for emergency response under controlled risks during global public health emergencies.

It typically requires the occurrence of a WHO-recognized emergency (e.g., PHEIC, Public Health Emergency of International Concern). Although the Nipah virus is listed as a "priority pathogen" by the WHO, it has not yet been declared a PHEIC, so the EUL has not been officially initiated.

Label/Instructions for Use Review:

It is essential to ensure that labels and instructions for use are clear and accurate, providing information on the product's intended use, testing limitations, and measures to take in the event of unexpected test results.

Performance and Safety Requirements:

Relevant data on the product's safety and effectiveness must be provided to support registration or licensing applications.

Performance evaluation must cover indicators such as analytical sensitivity and analytical specificity.