If you are an importer, manufacturer, or wholesaler of medical devices, it is crucial to understand and comply with the registration process set by the Central Drugs Standard Control Organization (CDSCO) in India. CDSCO is the regulatory authority responsible for the registration and regulation of medical devices in the country. In this article, we will walk you through the steps involved in applying for CDSCO medical device registration.
Importance of CDSCO registration
Before diving into the registration process, let's first understand why CDSCO registration is crucial for importers, manufacturers, and wholesalers of medical devices in India.
CDSCO registration ensures that medical devices meet the necessary safety and quality standards before they are introduced into the market. It helps in safeguarding the health and well-being of patients who rely on these devices for diagnosis, treatment, or monitoring of various medical conditions.
Additionally, CDSCO registration is a legal requirement under the Indian Medical Devices Rules, 2017. Non-compliance with the registration process can lead to penalties, product seizure, or even legal repercussions. Therefore, it is essential to adhere to the regulatory guidelines and obtain CDSCO registration for your medical devices.
CDSCO registration fees
Now let's discuss the registration fees associated with CDSCO medical device registration. The registration fees vary depending on various factors such as the type of device, intended use, risk classification, and import or manufacturing status. It is important to carefully assess the applicable fees based on your specific circumstances.
CDSCO has a fee structure in place for different types of medical devices. The fees range from INR 5,000 to INR 50,000, depending on the risk classification. The risk classification of medical devices is determined based on the potential risks associated with their use, such as invasiveness, duration of use, and contact with the human body.
It is advisable to consult the CDSCO guidelines and fee structure to determine the exact registration fees applicable to your medical device.
Medical device registration in India
Now that we have understood the significance of CDSCO registration and the associated fees, let's delve into the medical device registration process in India.
1. Determining the risk classification: The first step is to determine the risk classification of your medical device based on its intended use. CDSCO has categorized medical devices into four classes - Class A, Class B, Class C, and Class D, with Class D devices carrying the highest level of risk.
2. Preparation of technical documentation: Once you have determined the risk classification, you need to prepare the necessary technical documentation for your medical device. The documentation typically includes details of the device's design, intended use, specifications, manufacturing process, and performance data.
3. Appointing an Indian Authorized Agent: If you are an overseas manufacturer, it is mandatory to appoint an Indian Authorized Agent who will act as a liaison between you and CDSCO. The Authorized Agent should have a valid wholesale license and must be based in India.
4. Submission of application: The next step is to submit the application for CDSCO medical device registration. The application should be accompanied by the required technical documentation, proof of payment of registration fees, and any additional documents as specified by CDSCO.
5. Review and evaluation: CDSCO will review the submitted application and conduct an evaluation of the technical documentation. The evaluation process may involve assessment of the device's safety, performance, and quality parameters. CDSCO may also conduct inspections of the manufacturing and testing facilities, if required.
6. Granting of registration: If the application and the submitted documentation meet the necessary requirements, CDSCO will grant the registration for the medical device. The registration certificate will specify details such as the registered device's name, intended use, risk classification, and validity period.
7. Post-registration compliance: Once your medical device is registered with CDSCO, it is important to comply with the post-registration requirements. This includes periodic reporting of adverse events or incidents, submission of updated technical documentation in case of any changes, and compliance with labeling and packaging regulations.
CDSCO registration FAQs
Here are some frequently asked questions related to CDSCO medical device registration:
Q: What is the validity period of CDSCO registration?
A: The validity period of CDSCO registration for medical devices is typically five years. However, it may vary depending on the risk classification and other factors.
Q: Can I import or manufacture a medical device without CDSCO registration?
A: No, CDSCO registration is mandatory for importers and manufacturers of medical devices in India. Operating without a valid registration can lead to legal consequences.
Q: Can I apply for CDSCO registration online?
A: Yes, CDSCO provides an online portal for the submission of registration applications. It is advisable to submit the application through the online platform for convenience and ease of tracking.
Q: What should I do if there are changes to the registered medical device?
A: In case of any changes to the registered medical device, such as modifications in design, intended use, or manufacturing process, you need to submit updated technical documentation and seek approval from CDSCO.
Q: Are there any post-registration requirements for medical device importers?
A: Yes, medical device importersmusto comply with post-registration requirements such as reporting adverse events or incidents, ensuring compliance with labeling and packaging regulations, and maintaining records of distribution and sales.
These are just a few commonly asked questions related to CDSCO medical device registration. It is advisable to refer to the official CDSCO guidelines and consult with regulatory experts for accurate and up-to-date information.
Conclusion
Obtaining CDSCO registration is a critical step for importers, manufacturers, and wholesalers of medical devices in India. It ensures compliance with the necessary safety and quality standards, while also meeting the legal requirements set by the Indian Medical Devices Rules.
The registration process involves determining the risk classification, preparing technical documentation, appointing an Indian Authorized Agent (for overseas manufacturers), submitting the application, and undergoing review and evaluation by CDSCO. Once the registration is granted, it becomes crucial to comply with the post-registration requirements and maintain the necessary records and documentation.
By following the CDSCO registration process diligently and seeking expert guidance when needed, you can navigate the regulatory landscape effectively and bring your medical devices to the Indian market with confidence.
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China is one of the fastest growing markets for Medical Devices where the demand for devices is majorly met through exports.
National Medical Products Administration (NMPA) (formerly CFDA) and Centre for Medical Device Evaluation (CMDE) is responsible for the review of the medical device import registration applications of all 3 classes of devices (Class I, II & III).
Class II and III devices require clinical data from NMPA accredited labs whose approval can take up to 2 years.
While aiming at Chinese market entry, applicants should ensure that the key documents are duly attached to get approvals within the review timelines.
Some of the documents and review timelines include:
Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines.
Get complete document list for China Get Timelines for approval in China
Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines. With clear-cut knowledge on local Regulatory landscape, Freyr guides manufacturers in successful clinical testing and the study data compilation as regulated by the NMPA.
Freyr Expertise
Premarket Registration Support
- Regulatory Strategy
- Device Classification as per NMPA
- Assess Clinical Trial Requirements and Exemptions or CER
- In case of CER, Evaluation of Technical Clinical Information of a Predictive/Prototype CFDA Approved Device or Review of Existing Clinical Trial Tata Standards
- Technical Document Preparation and Gap Analysis
- Safety, Quality and Efficacy Assessment
- Regulatory Submission and Approval
- Compilation of Technical Documents and Registration Application
- Dossier Translation
- Clinical Testing Support and Management
- Risk assessment, QMS Audit and Compliance
- Self-assurance Statement Preparation
- IFU and Draft Label Preparation and Translation
- Labeling and Artwork Compliance
- Local Agent Support, Attend Review Meetings
- Liaison with HA until Approval
- Import Permit and Custom Support
Clinical Trial Support and Management
- Quality Maintenance
- NMPA Audit Preparation
- QMS Implementation and Monitoring Compliance
- Standard Operating Procedure (SOP) Writing and Implementation
- Quality Manual Writing
- Ethics Standard Implementation and Monitoring
- Ethical Review of Clinical Protocol
- GxP Compliance
- Clinical Trial Support
- CRO Oversight and Management
- Clinical Trial Application (CTA)
- Pre-clinical Investigation of Medical Devices
- Clinical Trial Protocol Design and Writing
- Clinical Trial Auditing and Quality Assurance
- Data Management and Statistical Analysis
- Clinical Studies Report Writing
Post-Approval Regulatory Support
- Post-Market Compliance
- Monitoring and Reporting Adverse Events
- Product Recall
- HA Query Responses to Regulatory and Audits
- Quality Management System (GMP and GSP compliance)
- Review of Extrapolating Studies
- Advertisement and Promotional Material Regulatory Compliance and Approval
- License Renewals and Updates- Technical Document Review and Filing
Summary
S. No | Regulatory Parameter | China | |
1 | Regulatory Authority | CFDA | |
2 | Regulation | State Council Order No.650 | |
3 | Risk Classification | Class I | |
Class II | |||
Class III | |||
4 | Regulatory Pathway | Class I | Notification |
Class II & III | Registration | ||
5 | Authorized Representative | China Agent required | |
6 | Fee payable | Class I | No Fee |
Class II | ~ $34,000* | ||
Class III | ~ $ 48,000* | ||
7 | QMS Requirement | YY/T0287-2017 | |
ISO 13485 | |||
8 | Assessment of Technical Data | Center for Medical Device Evaluation (CMDE) | |
9 | Validity of License | Class I | Unlimited |
|
| Class II & III | 5 Years |
10 | Labelling Requirements | Decree No.6 of CFDA | |
11 | Submission format | Paper | |
12 | Final Outcome | Class I | Notification |
|
| Class II & III | Registration Certificate |
13 | Timelines | Class I | 3 -6 months |
|
| Class II | 1 - 2 years |
|
| Class III | More than 2 years |
14 | Language | English & Chinese | |
*The price is as per records at the time of documentation and is subject to change.
Process Flow
To know more about NMPA’s drug regulations and the local Regulatory assistance, reach out to us at [email protected]
