India’s Central Drugs Standard Control Organisation (CDSCO)

The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body for medical devices in India. It is responsible for overseeing the import, manufacture, sale, and distribution of medical devices in the country. The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards. Upon approval of a manufacturer’s MD-14 application, the CDSCO will issue an MD-15 Import License according to the manufacturing site with the approved products listed on it. Therefore, if manufacturers use multiple manufacturing sites, an MD-15 for each site will be needed.

In order to sell a medical device in India, manufacturers must obtain a MD-15 Import License from the CDSCO. The CDSCO conducts inspections and audits to ensure that medical device companies are complying with regulations related to safety, quality, and efficacy. It also provides guidance on the approval process and requirements for specific product categories.

As the regulatory body for medical devices in India, the CDSCO plays a critical role in ensuring the safety and efficacy of medical devices that are sold in the country. Medical device companies must comply with the CDSCO’s regulations in order to successfully enter and operate in the Indian market.

Working with a medical device regulatory consulting company like Asia Actual can help medical device companies navigate the CDSCO’s requirements and obtain the necessary licenses and approvals for their products. These consulting firms can assist with product classification, registration support, post-market surveillance, and other aspects of the regulatory process. By working with an experienced regulatory consulting company, medical device manufacturers can ensure compliance with the CDSCO’s regulations, save time and resources, and successfully enter and grow in the Indian market.

Significant Recent CDSCO Regulatory Updates

The CDSCO has recently implemented several updates pertaining to medical device regulations. Here is a summary of some of the key changes:

1. Class A Measuring/Sterile and all Class B medical devices must now have an MD-15 Import License to be imported. Class C and D medical devices not already Notified must have an MD-15 Import License by October 1, 2023.
2. UDI Implementation status: India’s CDSCO has delayed implementation of UDI with no plan for implementation at this time.
3. Class A Non-Measuring and Non-Sterile devices: On October 14, 2022, the Indian Ministry of Health and Family Welfare issued final notification S.R. 777(E) formalizing the exemption of Class A non-measuring and non-sterile medical devices from the Import License (MD-15) process.
4. Medical Device Rules 2020: In April 2020, CDSCO introduced the Medical Device Rules 2020, which replace the earlier Medical Device Rules 2017. The new rules aim to streamline the regulatory process for medical devices and ensure patient safety.
5. Notification on Import and Registration of In-Vitro Diagnostic (IVD) Kits: In March 2021, CDSCO issued a notification on the import and registration of IVD kits. The notification outlines the requirements for the import and registration of IVD kits in India.
6. Online Registration for Medical Devices: In September 2020, CDSCO launched an online registration portal for medical devices. The portal enables manufacturers to submit applications for registration of their medical devices online, streamlining the registration process.
7. Changes in Medical Device Classification: In December 2020, CDSCO announced changes to the classification of medical devices. The changes include the reclassification of certain medical devices from low to moderate risk and from moderate to high risk.

Recent Asia Actual Blogs on India

India Enforcing Local Electrical BIS Certifications for Certain Medical Devices

Class A Non-Measuring/Sterile Devices Now Exempt from MD-15 Requirements

Identifying Predicate Devices in India, Taiwan, China, Japan, And Korea

India Issues New Sales License Requirement for Medical Devices

Registering Innovative Medical Devices in India

India’s CDSCO Temporarily Delays Implementation of UDI Requirements

India Grants Import License Grace Period for Class A/B Devices

More Information on NMPA Regulatory Requirements for Medical Devices

Our Overview of the Medical Device Registration Page

Predicate Device Identification in India

List of CDSCO approved Import Licenses

CDSCO Notices, Gazette Notifications and other updates

BIS accredited laboratories

Central Drugs Standard Control Organization (CDSCO) – http://www.cdsco.gov.in/

Ministry of Health and Family Welfare – https://www.mohfw.gov.in/

Medical Device Rules, 2017 – https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_Cosmetics_Act_Rules/MDR2017.pdf

Indian Pharmacopoeia Commission (IPC) – https://ipc.gov.in/

Indian Council of Medical Research (ICMR) – https://www.icmr.gov.in/

Bureau of Indian Standards (BIS) – https://www.bis.gov.in/

National Accreditation Board for Testing and Calibration Laboratories (NABL) – https://nabl-india.org/

Come Grow with Us

Contact Asia Actual if you have any questions and/or would like to learn more about accessing the Indian market specific to your product portfolio.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.