Pain management deals with the prevention of pain. This medicinal field is concerned with the evaluation, treatment, and rehabilitation of persons in pain. Notably, a comprehensive pain management approach guided by experts is the best way to tackle chronic pain. A pain management plan is used by healthcare providers to manage all kind and causes of pain. Moreover, various medical devices are required to effectively manage the pain. Thus, pain management medical devices have a critical role in the healthcare industry. Hence, CDSCO, the apex medical device regulatory body, ensures that safe and effective pain management devices reach Indian healthcare industry. Therefore, securing CDSCO pain management medical device license is mandatory to market your medical device in India.

In the field of pain management/medicine, a broad-based approach is used to treat pain that can be a symptom of a disease or the primary disease. It helps individuals with chronic pain feel better and improves their quality of life. However, it is not always possible to provide total relief from pain. Nevertheless, pain management helps with significant reduction in pain. This is usually administered by pain medicine specialists. These specialists have special training in evaluation, diagnosis, and treatment of different types of pain. They use various medical devices to diagnose, monitor, and treat pain. Hence, given the role of medical devices in pain management, regulating their quality, efficacy, and safety is essential. Thus, CDSCO has laid down stringent guidelines for manufacturing or importing pain management medical devices. Hence, manufacturers/importers have to mandatorily secure CDSCO license for pain management medical devices.

In this blog, we have detailed the CDSCO pain management medical device license application process. Additionally, we have provided an overview of the documents required. Furthermore, we have provided some tips to overcome common CDSCO license application challenges.

CDSCO pain management medical devices classification system

To understand the CDSCO pain management license application process, first let us understand the CDSCO medical device classification system. Medical devices are classified based on the potential risks associated with their use. They are categorised into four classes, A, B, C, and D, in increasing order of risks. Notably, this classification system has been developed to simplify the license application process. Moreover, different licenses and application processes are required for the different CDSCO class.

Use our free tool to check the class to which your pain management medical device belongs to. This will determine your CDSCO pain management medical device license application process.

CDSCO pain management medical device classes

We have listed some examples of pain management medical devices belonging to the different CDSCO classes.

CDSCO class A

• Acupressure calf band
• Acupressure wristband
• Bite relief pad
• Massage table/couch
• Sitz bath
• Sitz bath chair
• Static magnetic bed mattress overlay
• Static magnetic belt
• Static magnetic bracelet
• Traction system belt
• Pain-relief static magnet
• Pain-relief phototherapy skin patch

Class B

• Acupuncture electrical stimulation system
• Acupuncture kit
• Acupuncture point detector
• Analgesic PENS system
• Analgesic TENS system
• Arthritis TENS system
• Arthritis transcutaneous electrical joint stimulation system
• Bed/chair electric massager
• Blue/red/infrared phototherapy lamp
• Circulating-fluid thermal therapy system
• Cold-air therapy unit
• Exothermic heat therapy pack
• Musculoskeletal infrared phototherapy unit
• Wearable cervical spine traction device
• Wearable lumbar spine traction device

CDSCO class C

• Analgesic peripheral nerve electrical stimulation system
• Analgesic spinal cord electrical stimulation system
• Cryogenic analgesia unit
• Epidural anaesthesia kit
• Epidural/intrathecal anaesthesia kit
• Flexible fibreoptic epiduroscope
• Medium-wave diathermy treatment system
• Microwave diathermy treatment system
• Multi-modality physical therapy system
• Transcutaneous ElectroNeuro Stimulator (TENS) devices

Class D

• Implantable intrathecal infusion pump
• Implantable lumbar neuromuscular electrical stimulation system

CDSCO pain management medical device license application process

To manufacture pain management devices in India, you have to secure the CDSCO medical device manufacturing license. On the other hand, to import pain management devices into India, you have to secure CDSCO medical device import license. To secure these licenses, you have to comply with the CDSCO regulatory guidelines. Additionally, you have to prepare supporting documents to apply for the license. Furthermore, the application has to be submitted as per CDSCO guidelines and requirements. Hence, we have created this mini guide to help you in your CDSCO medical device license application journey. 

Documents required for securing CDSCO pain management medical device license

We have provided an overview of the documents required for securing CDSCO pain management 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 and experienced staff who can manufacture and test your medical devices.
7. Test License, if required for testing the pain management device
8. Environmental regulation compliance documents
9. Certificate of analysis of 3 consecutive batches
10. ISO 13485 Certificate

For a detailed list of documents required, feel free to contact us. Additionally, we will help you prepare and compile the documents as per CDSCO guidelines. Our team has extensive expertise in document preparation for CDSCO medical device license application.

Different CDSCO license types and requirements

Different license and application processes apply for different CDSCO classes.

1. Manufacturing class A and B pain management devices: You need to apply for MD 5 license. Moreover, a fee of Rs. 5,000 for the manufacturing license will be required. Additionally, Rs. 500 for each distinct device will be required. The license has to be obtained from the state licensing authority.
2. Manufacturing class C and D pain management devices: You need to apply for MD 9 License. Moreover, a fee of Rs. 50,000 for the manufacturing license will be required. Additionally, Rs. 1,000 for each distinct device will be required. The license has to be obtained from the central licensing authority.
3. Importing pain management devices into India: MD 15 Import License has to be secured from the CDSCO to import pain management medical devices into India.

A simplified overview of the CDSCO pain management device license application process

The CDSCO medical device license application process involves the following steps:

• Document preparation: Compile all necessary documents, including clinical trial data and product specifications.
• Application Submission: File the application online on the official CDSCO online portal. Ensure all details are accurate. Furthermore, properly attach all the documents.
• Query Resolution: CDSCO may raise queries that have to be promptly and accurately addressed. The queries can range from clarification of the submitted documents to requests for additional information. 
• Inspection: Prepare for the CDSCO medical device facility inspection and audit phase. CDSCO officials may visit the facility to ensure regulatory compliance. 
• License Approval: The regulatory officials will verify all the documents and review the application. Then, if all the criteria are satisfied, the CDSCO will grant the license. This license will permit you to manufacture or import, as applicable, pain management medical devices.

Validity of the CDSCO pain management device license

The CDSCO pain management medical device license is valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.

Common CDSCO medical device license application challenges and how to overcome them

Manufacturers and importers might face the following challenges while applying for their CDSCO license. Hence, we have provided some suggestions on how to overcome them.

• Documentation Gaps: Ensuring all documents are up-to-date and meet CDSCO’s requirements.
• Delays in Query Resolution: Setting up a dedicated team to address CDSCO queries promptly.
• Inspection Hurdles: Regular internal reviews of facilities to ensure they meet CDSCO guidelines.

How can Pharmadocx Consultants assist you in securing the CDSCO pain management medical devices license?

With expert partners like Pharmadocx Consultants, the CDSCO medical device licensing journey will be streamlined and efficient for you.

• Assistance throughout the CDSCO medical device registration process.
• Conducting pre-inspection audits to ensure readiness.
• Our team will help you promptly address CDSCO queries.
• Comprehensive support from the initial application to license approval. We will provide support till you successfully secure the CDSCO medical device license.

Are you planning to secure the CDSCO pain management medical device license? Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us help you.