Must-Have CDSCO License to Manufacture Dermatological and Plastic Surgery Products in India
Medical devices used in dermatological and plastic surgery must have a CDSCO license to ensure safety and effectiveness. This is a requirement for manufacturers, suppliers, and distributors of these devices in India. The CDSCO medical device licensing regime is a cornerstone for the healthcare sector and helps to protect patients.
Licensing authorities for Dermatological and Plastic Surgery Products in India
The Central Drugs Standard Control Organization (CDSCO) is the licensing authority for Class C and Class D Dermatological and Plastic Surgery Products and the State Licensing Authority is the licensing authority for Class A and Class B Dermatological and Plastic Surgery Products in India.
Benefits of CDSCO Medical Device License
A CDSCO medical device license is not just a requirement for manufacturers and suppliers of medical devices. It also offers several benefits to healthcare providers and patients.
- For healthcare providers, a CDSCO license provides assurance that the medical devices they are using are safe and effective. This helps them to provide better quality care to their patients. It also protects them from legal liability in case of any adverse events.
- For patients, a CDSCO license is a guarantee that the medical devices they are receiving are of the highest quality. This helps to reduce the risk of complications and ensures that they have the best possible chance of recovery.
- In addition to these benefits, a CDSCO medical device license also helps to promote transparency and accountability in the healthcare sector. It ensures that all medical devices on the market meet the same high standards of safety and efficacy.
- Overall, a CDSCO medical device license is an important safeguard for both healthcare providers and patients. It helps to ensure that high-quality medical devices are available to everyone in India.
List of “Class A” Dermatological and Plastic Surgery Products
- Surgical camera and accessories.
- Dermatome skin approximation tape
- Drape adhesive.
- Hydrophilic wound dressing.
- Internal tissue marker.
- Laparoscopy Tray
- Manual operating table and accessories and 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
List of “Class B” Dermatological and Plastic Surgery Products
- Organ bag.
- Low energy ultrasound wound cleaner
- Surgical drape and drape accessories
- Suture retention device
- Ultraviolet lamp for dermatologic disorders.
- Wound auto fluorescence 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
List of “Class C” Dermatological and Plastic Surgery Products
- Implantable ligating clip
- Laser surgical instrument for use in general and plastic surgery and in dermatology.
- Carbon dioxide laser
- Electrosurgical cutting and coagulation device and
- General electrosurgical unit
- Implantable staple
- Copper vapour laser
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Dermatological and Plastic Surgery Products Licensing Requirement:
- To manufacture Class A and Class B Dermatological and Plastic Surgery Products in India, you must obtain the MD 5 License from the State Licensing Authority.
- To manufacture Class C Dermatological and Plastic Surgery Products in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
- To import Dermatological and Plastic Surgery Products into India, you must obtain the MD 15 Import License from the CDSCO.
Requirements for Manufacturing, Importing, and Distributing Dermatological and Plastic Surgery Products in India
License Fee for Dermatological and Plastic Surgery Products in India
- Class A or Class B: ₹ 5,000/- for manufacturing license, ₹ 500/- for each distinct device.
- Class C or Class D: ₹ 50,000/- for manufacturing license, ₹ 1,000/- for each distinct device.
Validity of Dermatological and Plastic Surgery Products License in India
- Respiratory Products licenses are valid indefinitely, as long as the retention fee is paid every 5 years.
How to Apply Online for Dermatological and Plastic Surgery Products Manufacturing or Import License in India
- Step 1: Enroll your organization on CDSCO’s SUGAM Portal.
- Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
- Step 3: Upload the necessary documents and make the required payment.
- Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
- Step 5: The Team will conduct an audit at your manufacturing premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
- Step 6: Once all the conditions are met, CDSCO will grant the license.
Deadline for Obtaining Dermatological and Plastic Surgery Products Licenses in India
The deadline for obtaining Dermatological and Plastic Surgery Products licenses in India is October 1, 2022 for Class A and Class B devices, and September 30, 2023 for Class C and Class D devices.
List of Documents for Obtaining a Dermatological and Plastic Surgery Products Manufacturing Licenses in India
- Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
- Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
- Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
- Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
- ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
- Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File: This file contains detailed information about each medical device you will be manufacturing, including its design, manufacturing process, and testing procedures.
- Test License, if any: If you need a license to test your medical devices, you must obtain it before you can start manufacturing them.
- Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
- Certificate of Analysis of 3 Consecutive Batches: This certificate shows that the first 3 batches of medical devices you manufactured meet the required quality standards.