CDSCO Medical Device Registration in India
For medical device manufacturers in Oman seeking entry into the Indian market, understanding and complying with India’s regulatory framework is critical. The Central Drugs Standard Control Organization (CDSCO) is the governing body that regulates medical device registration in India. At Operon Strategist, we offer expert consulting services to help Omani manufacturers and exporters complete the CDSCO registration process smoothly and efficiently. Our goal is to ensure your devices meet all safety, quality, and regulatory standards required by the Indian Ministry of Health and Family Welfare.
What Is CDSCO Registration?
CDSCO registration is a mandatory regulatory process for medical devices being manufactured, imported, or marketed in India. It involves classification of the device based on risk, submission of technical documentation, and approval through the MD Online Portal.
Manufacturers from Oman must comply with CDSCO norms if:
- They are exporting medical devices to India.
- They are partnering with Indian companies for final packaging or distribution.
- They require import licenses or manufacturing licenses under Indian regulation.
Step-by-Step Process to Register Medical Devices:
Operon Strategist outlines the step-by-step process for CDSCO medical device registration:
- Determine Classification: Identify the regulatory classification of the medical device based on risk.
- Prepare Technical Documentation: Compile necessary technical documentation ensuring compliance with CDSCO requirements.
- Appoint an Indian Authorized Agent: Select a local representative in India for regulatory purposes.
- Submit Application to CDSCO: Prepare and submit the registration application with required documents.
- Review and Approval: CDSCO reviews the application and may request additional information. Cooperate with the process.
- Inspection and Quality Management: Certain high-risk devices undergo inspection. Ensure compliance with quality management standards.
- Approval and Registration: Upon successful review, CDSCO issues a registration certificate.
- Post-Market Surveillance: Ensure ongoing compliance with post-market requirements.
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CDSCO MD Online Registration:
The MD Online Portal is CDSCO’s centralized online system for:
- Import license applications
- Manufacturing licenses
- Device notifications and approvals
We guide you through account setup, document uploads, and submission on this portal—ensuring zero errors and faster approvals.
What is Classification of Medical Devices as per CDSCO:
MDR 2017 has categorized the devices as Class A, Class B, Class C and Class D. Below table will spread some light on classification of medical devices.
Type | Risk | Example |
Class-A | Low risk | Bandage, examination loves etc. |
Class B | Low-Medium Risk | B.P. monitoring device, thermometer |
Class C | Moderate to High Risk | Implants, catheter |
Class D | High Risk | Heart Valve. |
CDSCO Import License Registration for Medical Devices
For any medical device that is imported into India, it’s mandatory to have a CDSCO Medical Device Import License.CDSCO import license registration is mandatory for Class A and B and all notified Class C and D medical devices from 1st October 2022.
CDSCO import license will be mandatory for all non-notified Class C and D medical devices from 1st October 2023. The CDSCO voluntary registration of medical devices in India for all non-notified Class C and D medical devices will be valid up to 30 September 2023.
Many companies in India bring raw materials, semi-finished products, or components to India. In order to sell this finished medical device, the final assembly and final packaging of the medical device in India require a CDSCO manufacturing license. However, if you require a complete finished product outside India, you will require a CDSCO import license.
Ready to Start CDSCO Registration from Oman?
Why Omani Manufacturers Choose Operon Strategist
As a leading CDSCO registration consultant, Operon Strategist provides complete end-to-end regulatory solutions for medical device companies in Oman. Our services include:
- Risk classification and category assessment
- Technical documentation support
- Agent appointment and liaison services
- Application submission and tracking
- Response to CDSCO queries or audits
- Post-approval surveillance assistance
We act as your extended regulatory team, saving you time, costs, and compliance risks.
FAQs
What is CDSCO registration?
CDSCO registration is the mandatory process of getting approval from India's Central Drugs Standard Control Organization to manufacture, import, or sell medical devices in the Indian market. It ensures that devices meet the required safety, quality, and regulatory standards.
Do medical device manufacturers in Oman need CDSCO registration to export to India?
Yes. If you're an Omani manufacturer exporting medical devices to India, you must obtain CDSCO registration—either an import license or manufacturing license, depending on your business model. Operon Strategist helps Omani companies navigate this process efficiently.
What classes of medical devices require CDSCO registration?
Under India's MDR 2017 regulations, all devices categorized as:
Class A (low risk)
Class B (low-moderate risk)
Class C (moderate-high risk)
Class D (high risk)
must be registered with CDSCO. This applies to both notified and non-notified devices.
What documents are required for CDSCO registration?
Commonly required documents include:
Device Master File (DMF)
Plant Master File (PMF)
ISO 13485 certificate
Free Sale Certificate (FSC)
Labels and packaging information
Operon Strategist assists in preparing and reviewing all documentation as per CDSCO guidelines.
How long does the CDSCO registration process take?
The CDSCO registration timeline varies based on device classification, documentation accuracy, and CDSCO’s review speed. On average, it takes 4 to 6 months from application submission to approval.