CDSCO Non-Notified Medical Device Registration

India has strict rules to keep people safe and make sure medical devices work properly. Not all devices need a license right away. Some devices are non-notified because they have low risk or are still being checked for full regulation. For these devices, CDSCO allows voluntary registration to ensure they are safe and meet the required standards.

Non-notified medical device registration aims to bring each product into a proper compliance structure. This makes sure devices follow quality and safety rules before they enter the Indian healthcare market. CDSCO handles all applications through the online SUGAM portal. Local manufacturers and importers create their accounts and share basic information about their business and medical devices.

This registration makes it clear how a medical device works, what materials are used, and which safety standards are followed during production. Voluntary registration also prepares companies for the future, so they can meet stricter rules if the authorities officially require their device category.

The Medical Devices Rules 2017 support this compliance system by defining responsibilities for both manufacturers and importers. CDSCO experts review all records, permissions, certifications, and declarations before issuing the registration number. This process creates a strong control system for safe technology and better patient care across India. It also improves the global reputation of the Indian medical device industry.

What Are Non-Notified Medical Devices as per Medical Devices Rules 2017? 

Non-notified medical devices are devices not listed under CDSCO's mandatory licensing categories under the Medical Devices Rules 2017. These devices do not require a formal manufacturing or import license at the initial stage. Their risk is usually lower when compared with notified devices. They still play an important role in diagnosis, monitoring, or treatment.

To ensure safety, CDSCO allows voluntary registration so every product meets strong quality standards like ISO certification. This process also prepares companies for future regulations because many device categories gradually become notified over time. Non-notified devices gain legal recognition and market acceptance through this registration. It creates confidence for doctors, hospitals, and patients in India.

These categories include many low-risk medical devices that support treatment and care. The list changes as CDSCO updates regulations. Some devices from these groups may later move to the notified list. 

Non-notified medical device registration promotes health and safety. It also creates discipline in the medical device market. Here are the major benefits:

• Better Patient Safety: Registration confirms basic quality checks and certification, reducing the chance of unsafe or faulty devices.
• Stronger Trust: Doctors, hospitals, and distributors gain more confidence in registered products because approval comes from India's top health authority.
• Easier Business and Trade: Devices that have CDSCO registration can move across India with fewer restrictions. This makes it simpler for companies to sell, distribute, or import their products without facing extra delays.
• Better Market Recognition: When a device is officially registered, it gets more trust from hospitals, clinics, and buyers. Registered devices are more likely to be selected in medical tenders and government procurement.
• Ready for Future Rules: Voluntary registration helps companies prepare for stricter regulations if their device category becomes mandatory. This allows businesses to follow new standards quickly without stopping their work.
• Stronger Global Reputation: Following Indian regulations properly improves a company's trust and credibility. It also creates more chances to sell devices in other countries.

Who Can Apply for Non-Notified Medical Device Registration in India? 

Any business involved in manufacturing or importing non-notified medical devices in India can apply for registration. Local manufacturers must ensure their factory follows strong quality control practices and international standards like ISO 13485. Importers should receive clearance from the country of origin showing that the device is legal and safe.

Both types of applicants must create accounts on the CDSCO SUGAM portal and submit the necessary details about the device. The applicant becomes responsible for the safety, quality, and performance of the products released into the Indian market. Distributors or traders cannot apply unless they hold proper authorization and required compliance certificates.

Key Tips for Successful CDSCO Non-Notified Medical Device Registration

Before starting the application, proper planning avoids rejection and delays. These are some helpful tips to follow:

• A valid ISO 13485 certificate must be in place for both imported and locally manufactured medical devices.
• Imported medical devices must have a Free Sale Certificate issued by the country of origin.
• The regulatory status of the device should be confirmed before starting the registration process to avoid delays or rejection.
• Proper device classification under the Medical Devices Rules 2017 must be ensured if the authority does not already define it.
• All details submitted on the portal should be accurate and supported with correct documents to maintain compliance.

The registration process needs verified documents that show:

• Free Sale Certificate (FSC)
• ISO 13485 Certificate
• Technical Device Information (intended use, materials, accessories, dimensions, sterilization method, shelf life)
• ID Proof of Authorized Person
• Undertaking / Declaration
• Certificate of Incorporation / Corporate Address Proof
• Manufacturing License (for domestic manufacturers)
• Wholesale License (if applicable or justification if not available)

The CDSCO SUGAM portal has been designed to make regulatory approvals transparent and easy to manage. Every step in the portal supports proper verification and prevents errors. Here are the major steps that form the core of the registration process:

• Access the Online Registration Portal: The first step for applying for voluntary registration of a non-notified medical device is visiting the designated online portal created by the regulatory authority. This platform is designed to simplify the complete registration journey for manufacturers and importers.
• Create an Account on the Portal: The applicant must create a new user account by entering a valid email address and mobile number. These details must be correct and active because future communication and verification will rely on them.
• Complete the Initial Profile Setup: After signing up, the applicant has to fill in basic information about the company and product. The portal will require uploading mandatory compliance details to confirm business authenticity and technical capability. These details prove that the company is legally allowed to manufacture or trade medical devices.
• Mobile Verification for Security: Once the initial details are submitted, a One-Time Password (OTP) is sent to the registered mobile number. The applicant must enter the OTP on the portal to verify their identity.
• Upload Technical Records and Certificates: After verification, the applicant can log in and upload all necessary documents related to quality, safety, and business operations. The submission must follow the checklist provided by the authority to avoid delays.
• Final Submission and Review: Once all the information is uploaded, the applicant can submit the registration request for official review. After approval, the authority issues the Voluntary Registration Number (VRN), confirming compliance with India's medical device regulatory system.

The registration number remains valid as long as the medical device continues to fall under the non-notified category. CDSCO may revise the regulatory status of different devices based on risk studies, technology changes, or new safety findings. If the category becomes notified in the future, the business must move to the mandatory license system to keep legal market access. Following quality standards consistently, keeping all certifications up to date, and regularly checking the device helps make sure the registration stays valid throughout its entire life.

The fee for registering a non-notified medical device in India depends on different factors. It changes depending on whether the company makes the device in India or imports it from another country. The type of device, the technology used, and how it is reviewed by the authorities also affect the cost. If the device category later becomes mandatory, the fee changes according to the new rules. This system ensures that every device is charged fairly based on its risk and regulatory requirements.

Corpseed is one of the top consulting firms, offering comprehensive assistance in the medical device and pharmaceutical compliance, guiding businesses through the necessary processes. We help companies and importers understand the non-notified medical device registration rules, prepare the required documents, and complete the registration process smoothly. Our services make it easier for businesses to get their devices approved and ready for the Indian market.

• End-to-End Assistance: We manage the entire registration process from document preparation to submission and follow-up with authorities.
• Document Guidance: We ensure all required certificates, technical details, and declarations are correctly prepared and verified.
• Regulatory Expertise: We provide clear advice on classification, compliance requirements, and changes in CDSCO regulations.
• Quality Check Support: We help verify that the devices meet ISO and safety standards before submission.
• Future Preparedness: We assist companies in preparing for mandatory registration if the device category becomes notified in the future.