CDSCO
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How CDSCO Oversees Regulatory Affairs for Medical Devices
The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for overseeing the regulation and approval process of medical devices in India. Here's a detailed explanation of how CDSCO governs regulatory affairs for medical devices:
CDSCO oversees regulatory affairs for medical devices in India by implementing a comprehensive regulatory framework, which includes registration and approval processes, quality management system requirements, import licensing, post-market surveillance, inspections, and aligning with international standards. Compliance with CDSCO regulations is essential for ensuring the safety, efficacy, and quality of medical devices marketed in India.
Regulatory Framework
CDSCO operates within the framework of the Drugs and Cosmetics Act, 1940, and the Medical Device Rules, 2017. These regulations outline the requirements for the registration, manufacturing, import, distribution, and sale of medical devices in India.
Classification of Medical Devices
CDSCO categorizes medical devices into different classes based on their risk level. This classification determines the regulatory pathway and requirements for obtaining approval or clearance for marketing the device in India. in-vitro diagnostic (IVD) is a product used for disease diagnosis, treatment, or prevention in humans or animals. IVDs are classified into four risk-based classes: Class A, B, C, and D. Class A and B IVDs are considered low-to-moderate risk. Class A IVDs are low-risk devices that require little invasiveness, such as specimen receptacles and laboratory instruments. Class B IVDs are low-to-moderate risk devices with minimal invasiveness, such as fertility and cholesterol tests
Registration and Approval Process
Medical device manufacturers, importers, or distributors must obtain approval or registration from CDSCO before marketing their products in India. The approval process involves submitting detailed technical documentation, clinical data (if applicable), and evidence of compliance with relevant standards and guidelines.
Quality Management System (QMS) Certification
CDSCO mandates that medical device manufacturers comply with quality management system requirements specified under ISO 13485 or its equivalent. Manufacturers must obtain QMS certification from an accredited certification body as part of the regulatory compliance process.
Import Licensing
Importers of medical devices are required to obtain import licenses from CDSCO before importing devices into India. The import license application process involves providing details of the device, manufacturing facilities, intended use, and compliance with regulatory requirements.
Post-Market Surveillance
CDSCO monitors the safety and performance of medical devices through post-market surveillance activities. This includes adverse event reporting, periodic safety updates, and conducting inspections of manufacturing facilities to ensure compliance with regulatory standards.
Labeling and Packaging Requirements
CDSCO specifies labeling and packaging requirements for medical devices to ensure accurate identification, traceability, and user safety. Manufacturers must comply with these requirements before placing their devices on the market.
Inspections and Audits
CDSCO conducts routine inspections and audits of manufacturing facilities, importers, and distributors to assess compliance with regulatory requirements. Non-compliance may result in regulatory actions such as suspension or cancellation of licenses.
Harmonization with International Standards
CDSCO aligns its regulatory requirements with international standards and guidelines to facilitate the global harmonization of medical device regulations. This includes adopting standards established by organizations such as the International Medical Device Regulators Forum (IMDRF) and the International Organization for Standardization (ISO).