By Team Metacorp on 06 Jul 2023
What Is the Process for CDSCO Medical Devices Registration in India
What Is the Process for CDSCO Medical Devices Registration in India?- CDSCO belongs to the Central Drugs Standard Control Organization which is Established under the Drugs and Cosmetics Act, of 1940, CDSCO operates under the purview of the Ministry of Health and Family Welfare, Government of India. CDSCO plays an important role to regulate the import, distribution and manufacture, and sale of drugs and medical devices in India. CDSCO plays an important role in safeguarding public health by regulating the pharmaceutical and medical device industry in India. Its guidelines and regulations aim to ensure the availability of safe, effective, and quality healthcare products to the Indian population. So it is clear that CDSCO is very important for the healthcare sector but now the question is What Is the Process for CDSCO Medical Devices Registration in India? In this blog, we mention the procedure of CDSCO registration.
Determine the Product Classification
Medical devices are classified into 4 different risk classes, Class A, Class B, Class C, and Class D that are based on their intended use and associated risks. The classification helps determine the regulatory requirements and the level of scrutiny applied during the registration process. The Fee of CDSCO for application processing depends on the device application. Identify the appropriate classification for your device according to the Indian Medical Devices Rules, 2017. Usually, the application process needs 6 to 9 months or if you want some innovation then it requires additional time. Once it is approved, an import license is issued for each manufacturing site listing the verification of the product.
|Class A||Low-Risk Devices||Eg. bandages, walking aids, and non-invasive thermometers|
|Class B||Low-to-moderate risk devices||Eg. syringes, catheters, and surgical gloves|
|Class C||Moderate-to-high risk devices||Eg. implantable devices, blood pressure monitors, and cardiac stents.|
|Class D||High-risk devices||Eg. heart valves, pacemakers, and certain diagnostic imaging equipment.|
Medical Devices Regulatory Pathways
In India, medical device regulatory pathways are determined based on the risk classification of the device. Less-risk devices classified as Class A typically go along with the self-declaration pathway. Manufacturers are needed to self-declare conformity with the essential principles and general safety and performance requirements. They still need to comply with labeling and manufacturing requirements. Apart from this, Moderate-to-high-risk devices classified as Class B, Class C, and Class D require a more rigorous regulatory pathway. The procedure generally involves the following steps:
- Preparation of Technical Documentation: For CDSCO Medical Devices Registration manufacturers should prepare technical documentation such as device specifications, manufacturing details, risk assessment, design information, clinical data, and evidence of conformity to relevant standards.
- Submission of Application: A registration application must be submitted to the Central Drugs Standard Control Organisation (CDSCO) by manufacturers or their authorized representatives. The technical information should be sent with the application, together with any necessary paperwork and costs.
- Application Form: Fill out the application form for medical device registration as per CDSCO guidelines. Manufacturers may request added clarification or information during the evaluation procedure. CDSCO reviews the submitted technical documentation and submitted applications to ensure compliance with regulatory demands.
- ProductsDiscription: Gave a detailed description of the device, including its technical specifications, intended use, and labeling information. Product-specific requirements depend on the device risk classification, CDSCO may necessary testing of the medical device in an authorized laboratory in India, Th testing includes safety, performance, and biocompatibility assessments.
- Manufacturing information: Submit information about the manufacturing facilities, quality control procedures, and compliance with Good Manufacturing Practices (GMP).To determine whether Good Manufacturing Practises (GMP) and other quality requirements are being followed, CDSCO may inspect the manufacturing site. The inspection checks to see if the quality control techniques, production processes, and regulatory compliance are all in order.
- Clinical data: If applicable, provide clinical data or evidence supporting the safety and efficacy of the device.CDSCO Medical Devices Registration in India certificate allows the manufacturer and sell the products in India. The registration certificate for the medical device is issued by CDSCO if the application and accompanying materials are in compliance with all requirements.
- Risk Assessment: After CDSCO Medical Device registration Certificate, manufacturers must comply with post-market surveillance requirements, such as adverse event reporting and periodic safety updates. Conduct a risk assessment for the device and provide the necessary documentation.
Appoint an Indian Agent For Home Country Approval Requirements
Non-Indian manufacturers are needed to appoint an Indian agent who will act as a liaison between the manufacturer and the CDSCO. Home Country Approval is not necessary but applicants will submit evidence of a reference country’s approval. Reference nations such as Canada, the USA, the EU, Australia, and Japan. Moreover, the Indian agent serves as a representative of the manufacturers and facilitates communication with the regulatory authorities, such as the Central Drugs Standard Control Organization (CDSCO).
- Validity and Renewal
- License Holder Requirements
- License Transfer
We hope this article on “What Is the Process for CDSCO Medical Devices Registration in India”, but still if you have any confusion contact Metacorp for assistance with your medical device registration in India. It is a 7+ years of experience certified company that delivered over 300 certificates. Offered services are very cost competitive. Moreover, it always deals in a transparent manner and executive offer first-hand information regarding the process for each service to our customers.