Operation theatre medical devices have a crucial role in facilitating surgeries and ensuring positive patient outcome. In addition to specialized equipment, basic general operation theatre medical devices, such as surgical table, have equally important roles. Furthermore, operation theatre medical devices are required to monitor patient vitals and ensure patient safety.  Thus, operation theatre medical devices have a pivotal role in the success of a surgery. Therefore, their quality, efficacy, and safety have to be strictly regulated to deliver high-quality healthcare to patients. Central drugs standard control organisation (CDSCO) is the top regulatory body for all medical devices in India. Hence, operation theatre medical device manufacturers and importers are required to abide by CDSCO regulations. Thus, securing the CDSCO operation theatre medical device license is a mandatory requirement. We have curated this blog to guide you through the CDSCO medical device license application process for operation theatre devices.

Medical devices for operation theatre: Key for a successful surgery

An operation theatre (OT) or operating room (OR) is a sterile environment where surgical procedures are performed. Advanced medical instruments and devices are present in this room to help surgeons perform their surgery. Moreover, this controlled environment is required to maintain strict hygiene and asepsis to prevent infection. Additionally, regulated temperature, airflow, and lighting are required to provide optimal conditions for both the patient and surgical team. Furthermore, specific medical devices for operation theatre are required for proper functioning of the OT.

Operation theatre medical devices are required to provide life-saving treatments and improve patient outcomes. The devices encompass a wide range of tools and equipment essential for surgical procedures. Each device plays a crucial role in ensuring the safety and success of surgical interventions. Surgical tables, OT lighting systems, anaesthesia machines, and monitoring devices are the basic medical devices for operation theatres. Moreover, the specific surgical procedure will require specialized medical devices. Additionally, specialised devices, such as endoscopic instruments, microscopes, and electrosurgical units, are used to further enhance surgical precision and efficiency. Notably, adequate device maintenance and calibration are vital to guarantee optimal performance and patient outcomes during surgical procedures. Furthermore, advancement in operation theatre medical devices, such as robotic-assisted surgery and minimally invasive surgical tools, is revolutionising modern surgical practices.

Key features of operation theatre equipment and instruments:

• High precision and accuracy
• Durability and reliability
• Medical device safety
• Seamless integration into other hospital equipment
• Advanced imaging features and technology
• User friendly

Therefore, the quality and efficacy of operation theatre medical devices will affect the surgical outcome and patient safety. Hence, they have to be stringently regulated to provide high-quality healthcare to patients and protect the public health.

How to secure the CDSCO operation theatre medical device license?

To apply for CDSCO operation theatre medical device license, first you need to understand the CDSCO medical device classification system. The CDSCO class of your medical device will determine the course of the license application process. Hence, we have provided a brief overview.

Operation theatre medical device classification system

The CDSCO has classified medical devices into four classes. This system is based on the risk level associated with the intended use of the device. The classes in increasing order of risk level are A, B, C, and D. This CDSCO medical device classification system has been developed to ease out the medical device license application process. Moreover, specific application processes and licenses are applicable for specific CDSCO medical device classes. Hence, the first step in the license application process is to check which class your device belongs to, as it will determine the next course of action.

CDSCO operation theatre medical device classes

To check which class your medical device belongs to, you can use our free tool. We have listed few examples of operation theatre devices belonging to the different CDSCO classes.

CDSCO class A

• Distractor/Retractors
• Suction system portable, Electrical/Pneumatic
• Suction system operated by vacuum
• Operation table system
• General-purpose diagnosis/treatment table
• Surgical light system
• Motorized diagnostic imaging view box
• General-purpose manually-operated operation table

Class B

• Hemostatic clip applier
• Hemostatic knife
• Scalpel
• Scalpel blade
• Surgical forceps
• Staple remover
• Surgical punch
• Surgical file
• Blood vessel surgical stripper
• Surgical probe
• Powered general-purpose operation table
• Operation table system

Class C

• General-purpose electrosurgical unit
• Long-term use enterostomy feeding tube
• Gastrostomy tube for long-term use
• Warming high-flow infusion pump
• Multiparameter monitor with critical parameters
• Surgical robot unit
• High-flow blood transfusion pump

CDSCO operation theatre medical devices license types and requirements

• Importing operation theatre medical devices into India: MD 15 Import License has to be secured from the CDSCO to import operation theatre medical equipment into India.
• Manufacturing class A and B operation theatre devices: MD 5 License will be required to manufacture class A and B operation theatre devices. Moreover, a fee of Rs. 5,000 for the manufacturing license is required. Furthermore, Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Manufacturing class C and D operation theatre devices: MD 9 License  will be required to manufacture class C and D operation theatre devices. Moreover, a fee of Rs. 50,000 for the manufacturing license is required. Furthermore, Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.

CDSCO operation theatre medical devices license validity

The CDSCO operation theatre medical devices license is valid indefinitely. However, the license retention fee has to be paid every 5 years to maintain the license validity.

Necessary supporting documents for the CDSCO operation theatre medical devices license application

We have listed the documents required to apply for the CDSCO operation theatre medical devices license.

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

In the above list, we have provided an overview of the documents required. For a detailed list of documents, feel free to contact us. Moreover, we have extensive expertise in CDSCO document preparation requirements. Our team of experts will help you prepare and compile the documents as per CDSCO requirements.

CDSCO operation theatre medical devices license application process: A step-by-step guide

The CDSCO license application process for operation theatre medical devices involves the following steps:

• Document preparation: Compile all necessary documents, including clinical trial data and product specifications. All supporting documents have to be meticulously prepared.
• Application Submission: File the application online on CDSCO’s official online portal. Additionally, upload all the necessary documents.
• Query Resolution: CDSCO may raise queries that have to be promptly and accurately addressed.
• Inspection: The regulatory officials may visit the medical device facility to carryout inspection and audit.
• License Approval: The regulatory officials will review the application and verify the documents. Once all the criteria are satisfied, CDSCO will grant the medical device license.

Pharmadocx Consultants team will help your easily secure the CDSCO medical device license

Mandatory CDSCO medical device license requirement ensures that healthcare professionals are equipped with the best tools for patient care. Moreover, compliance with CDSCO regulatory guidelines is a testament of the manufacturer’s dedication to patient safety and product quality. Furthermore, staying compliant ensures trust in the brand and helps avoid potential regulatory repercussions. We at Pharmadocx Consultants offer comprehensive services to support medical device manufacturers and importers. Are you planning to apply for the CDSCO operation theatre medical license? Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us help you.