Get CDSCO License for Surgical Instruments for General Use

As general use surgical instruments are intended for general surgical procedures, they have to be strictly regulated. The Central Drugs Standard Control Organization (CDSCO) is at the helm of medical device regulation in India. It aims to protect public health, safeguard the Indian healthcare system, and improve patient outcome. Hence, securing the CDSCO license for surgical instruments for general use is mandatory for manufacturing or importing these devices. In this guide, we offer a comprehensive look into the CDSCO license application process, documents required, and license types. Furthermore, we have provided tips on how to overcome common challenges faced during the CDSCO medical devices license application process.

What are surgical instruments for general use?

Surgical instruments for general use are surgical instruments intended to be used in various general surgical procedures.

CDSCO definition for non-sterile, nonpowered, hand-held or hand-manipulated surgical instruments for general use: “Non-Sterile and Invasive Surgical Instruments are commonly intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device”. These devices are intended to be used after appropriate procedures, such as cleaning, disinfection, and sterilization.

Understanding CDSCO medical device classification system for general use surgical instruments

Medical devices have been categorised based on the potential risks associated with their use. The CDSCO medical device classification system has been formulated to simplify the CDSCO license application process. The devices are categorised into four classes, A, B, C, and D, in increasing order of risks. Different licenses and application processes are required for the different CDSCO classes. We have listed some examples of general use surgical instruments under the CDSCO medical device classification system. Notably, most of the instruments belong to class A.

CDSCO classes for general use surgical instruments

Class A

• Cutting and Dissecting Surgical instruments
• Clamping and Occluding Surgical instruments
• Retracting and Exposing Surgical instruments
• Grasping and Holding Surgical instruments

We have listed few examples. To check which class your instrument belongs to, use our free tool.

Different CDSCO license types for surgical instruments for general use

General use surgical instruments mostly belong to class A medical devices. CDSCO licensing requirements for class A medical devices slightly vary depending on whether the devices are sterile and measuring. We have provided an overview.

• CDSCO registration: Per updated guidelines, you will now be able to manufacture or import Class A (non-sterile and non-measuring) medical devices in India without a CDSCO license. You can start your business by simply securing a CDSCO registration for class A medical devices. Notably, non-sterile and non-measuring Class A medical devices mandatorily require the CDSCO registration. Moreover, this CDSCO registration number has to be mandatorily mentioned on the label of the medical device.
• CDSCO manufacturing license: MD 5 license will be required to manufacture sterile and measuring class A medical devices. Moreover, a fee of Rs. 5,000 for the manufacturing license and Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• CDSCO import license: MD 15 import license has to be obtained to import sterile and measuring class A medical devices.

Documents required for CDSCO license for surgical instruments for general use

Documents for CDSCO Class A registration

1. Manufacturing company and facility’s name and address
2. Details of the medical device whether it is sterile or non-sterile. Additionally, generic name, model number, class, intended use, material of construction, and dimensions have to be mentioned.
3. Shelf life or expiry date of the device.
4. Undertaking duly signed by the manufacturer stating that the proposed device is a non-sterile and non-measuring Class A medical device.
5. The manufacturer is required to certify the device conforms with the Essential Principles Checklist (EPC).
6. The manufacturer is required to certify the medical device complies with the standards specified in Medical Device Rules, 2017.
7. Certificate of compliance with the ISO 13485 and BIS standards
8. Undertaking duly signed by the manufacturer stating that the information furnished is accurate.

Documents required for CDSCO medical device license

1. Organization identity proof
2. Sale Deed/Rent Deed of the Premises
3. Plant Master File
4. Building Layout with Dimension
5. Device Master File
6. Documents for the team of qualified staff who will manufacture and test your medical devices.
7. Test License, if required for testing the device
8. Environmental regulation compliance documents
9. Certificate of analysis of 3 consecutive batches
10. ISO 13485 Certificate

We have provided an overview of the documents required for the two license types. If you need help understanding which set of documents is necessary for your license type, feel free to contact us. Furthermore, we will help you prepare and compile the documents as per CDSCO guidelines.

How to obtain CDSCO license for surgical instruments for general use?

The license type required for your device will depend on the CDSCO class your instrument belongs to. Additionally, whether your instrument is sterile and measuring is a major factor in determining the CDSCO license application process. Hence, first determine whether your general use surgical instrument will require a CDSCO registration or license. This will help you understand how to proceed with the CDSCO license application process. We have provided a step-by-step guide for both the processes.

Steps for securing the CDSCO Class A registration

1. Login/Signup on the official CDSCO online portal SUGAM. Register on the portal with a valid email address and mobile number.
2. Upload a government id proof. Company documents, such as GST number and CIN, will have to be uploaded.
3. Upload the aforementioned necessary documents.
4. Then, proceed with the CDSCO registration process.

Steps for securing the CDSCO medical device license

1. Collate all necessary documents required for CDSCO license application.
2. File the application on the CDSCO’s official online portal, SUGAM.
3. CDSCO officials will review the application and verify the documents.
4. Promptly address any queries raised by CDSCO. They may request for additional documentation or clarification. Provide all necessary supporting documentation as required.
5. Once all criteria are satisfied, the CDSCO will grant the applicable CDSCO medical device license.

Validity of the CDSCO license for general use surgical instruments 

CDSCO general use surgical instruments license is valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.

Common CDSCO license application challenges and how to overcome them

Manufacturers and importers applying for the CDSCO manufacturing or import license might grapple with the following challenges. We have provided some tips on how to overcome them.

• Incorrect license/registration application: Thoroughly check whether your device requires a license or registration. Then, proceed with the application accordingly.

• Inconsistent and incomplete documentation: Ensure all documents are current, complete and resonate with CDSCO’s standards.
• Incorrect and delayed query resolution: Establish a dedicated team to swiftly address the CDSCO queries. Queries need to answered correctly.

How can Pharmadocx Consultants assist you in securing the CDSCO license?

Compliance with CDSCO regulatory guidelines is a mandatory requirement for medical device manufacturers and importers. Importantly, CDSCO regulatory compliance will translate to consistent product quality and efficacy. However, navigating the CDSCO regulatory guidelines is a tough task. You have to decide whether your surgical instrument will require a CDSCO license or a simple registration. This will determine the necessary documents required and application process. As medical device companies, it is not possible to stay abreast of the latest regulations and determine the application process. With our support, your CDSCO license application process is going to be a cake walk. We at Pharmadocx Consultants offer a suite of services tailored for our clients:

• Expert Guidance: Guidance and support throughout the CDSCO medical device registration/licensing process.
• Mock Audits: Conducting mock audits to identify areas of non-compliance and provide mitigation strategies.
• CDSCO Query Resolution: Our team will help you promptly and accurately address all queries raised by the CDSCO.
• End-to-End Support: All-encompassing support from application to license approval.

With the help of the seasoned Pharmadocx Consultants team, the registration/licensing pathway will be seamless for you. Need expert guidance with securing the CDSCO license for surgical instruments for general use? Drop an email at [email protected] or call/Whatsapp on 9996859227 to partner with Pharmadocx Consultants today!