Medical devices that are used in dermatological and plastic surgery should have a CDSCO license for dermatological and plastic surgery products to ensure safety and effectiveness. This is an important requirement for these devices’ manufacturers, suppliers, and distributors in India. The CDSCO license for medical device regimes is a cornerstone for the healthcare sector and helps to protect patients.

Licensing authorities for Dermatological and Plastic Surgery Products in India

Licensing Authorities For CDSCO license for dermatological and plastic surgery products are followed by:-

• The responsible licensing authority for Class C and Class D dermatological and plastic surgery products: The Central Drugs Standard Control Organization (CDSCO).
• The responsible licensing authority for Class A and Class B dermatological and plastic surgery products: The State Licensing Authority in India.

The list of Class A Dermatological and Plastic Surgery Products is followed by

• Surgical camera and accessories.
• Dermatome
• Dermatome skin approximation tape
• Drape adhesive.
• Hydrophilic wound dressing.
• Internal tissue marker.
• Laparoscopy Tray
• Manual operating table and accessories
• manual operating chair and accessories
• Manually-operated dermatome
• Occlusive wound dressing.
• Plastic surgery osteotome
• Reusable dermatome blade
• Skin marker
• Surgical apparel.
• Surgical guillotine
• Surgical lamp
• Non-powdered surgeon’s glove
• Eye pad

The list of Class B Dermatological and Plastic Surgery Products is followed by

• Organ bag.
• Low-energy ultrasound wound cleaner
• Surgical drape and drape accessories
• Suture retention device
• Ultraviolet lamp for dermatologic disorders.
• Wound autofluorescence imaging device
• Battery-powered trephine system
• Colonoscope, General & Plastic Surgery
• Cryosurgical unit and accessories
• Dermal dilator
• Electrically-powered trephine system
• Electrosurgical device for over-the-counter aesthetic use
• Esophagoscope, General & Plastic Surgery
• Gas-powered dermatome
• Gas-powered trephine system
• Gastroscope, General & Plastic Surgery
• Hemostatic knife
• Irrigating wound retractor device.
• Laparoscope, General & Plastic Surgery
• Liposuction catheter
• Powered corneal trephine
• Powered dermatome
• Powered suction pump.
• Removable skin clip
• Removable skin staple
• Single-use dermatome blade
• Skin Stapler

The list of Class C Dermatological and Plastic Surgery Products is followed by

• Implantable ligating clip
• Laser surgical instrument.
• Carbon dioxide laser
• Electrosurgical cutting and coagulation device
• General electrosurgical unit
• Implantable staple
• Copper vapor laser

Requirement of  CDSCO License For Dermatological And Plastic Surgery Products :

• You have to get the MD 5 manufacture License from the State Licensing Authority to production of Class A and B Dermatological and Plastic Surgery Products in India.
• You have to get the MD 9 manufacture License from the Central Drugs Standard Control Organization (CDSCO) production of Class C Dermatological and Plastic Surgery Products in India.
• You have to get the MD 15 Import License from the Central Drugs Standard Control Organization (CDSCO) To import Dermatological and Plastic Surgery Products into India.

Required form for CDSCO License For Dermatological And Plastic Surgery Products

• Form MD 5 is a License from the State Licensing Authority for Class A and Class B devices 
• Form MD 9 is a License from the CDSCO for Class C and Class D Devices 
• Form MD 15 is an Import License from the CDSCO for Import.

Cost of License for Dermatological and Plastic Surgery Products in India

The cost of a license for manufacturing of Class A or Class B device is ₹ 5,000/- only and ₹ 500/- only for each distinct device. The cost of a license for manufacturing of Class C or Class D device is ₹ 50,000/- only and ₹ 1,000/- only for each distinct device.

Validity and retention of CDSCO License For Dermatological And Plastic Surgery Products

The manufacturing Licenses of Dermatological and Plastic Surgery Products are valid indefinitely; the renewal fee must paid every five years.

procedure to Apply Online for Dermatological and Plastic Surgery Products Manufacturing or Import License in India

• Step 1: You must enroll in your organization on CDSCO’s SUGAM Portal.
• Step 2: The respective forms of applications need to be submitted via the CDSCO’s online SUGAM Portal after filling out.
• Step 3: All the required documents need to be uploaded and then make the payment.
• Step 4: The CDSCO Team will scrutinize your application. If it meets all the requirements of CDSCO, it will proceed to a quality management system compliance audit.
• Step 5: The Team will conduct an audit at your manufacturing premises. If the team determines any Non-Conformance (NC), you should submit an NC closure report to CDSCO.
• Step 6: After all the requirements are met, CDSCO will issue the CDSCO license for dermatological and plastic surgery products.

List of Documents required for Obtaining CDSCO License For Dermatological And Plastic Surgery Products

• Organization identity proof: List of Partners or Directors, The Memorandum of Association, UDYAM Aadhar, or PAN card.
• Sale Deed or Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will manufacture the dermatological and plastic surgery products.
• Plant or Site Master File: This file contains details about the layout of your manufacturing facility and the device and processes you will be using.
• Building Layout with Dimension: This is a detailed map of your manufacturing facility, showing each room’s dimensions and the location of all equipment.
• ISO 13485 Certificate and Previous Audit Reports: This certificate proves that your manufacturing facility meets the requirements of international standards for quality management systems.
• Competent Technical Staff for Manufacturing and Devices Testing: You should have a team of experienced and qualified staff who can manufacture and test your medical devices.
• Device Master File: This file encloses detailed information about each medical device you will be manufacturing, including its design, process of manufacturing, and testing procedures.
• Test License, if any: If you want a license to test your medical devices, you must get it prior to the manufacturing of the medical device.
• Compliance with the environmental requirements: You should comply with all applicable environmental regulations, such as those relevant to cleanrooms for manufacturing the devices.
• Certificate of Analysis of Three Consecutive Batches: This certificate proves that the first three batches of medical devices you manufacture meet the required quality standards.