Dermatological and plastic surgery medical devices are in high demand in India. Medical device manufacturing companies are trying to tap into the potential of this sector of the medical device industry. The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for all medical devices in India. The CDSCO aims to ensure substandard medical devices intended for dermatological and plastic surgery use do not enter the Indian market. This blog will break down the requirements and process for CDSCO registration for dermatological and plastic surgery medical devices.

What are dermatological and plastic surgery medical devices?

Dermatologists focus on treating skin diseases whereas plastic surgeons perform surgeries mainly for aesthetic reasons. Dermascope, dermatology lasers, dermal cutter, light therapy, etc. are the common medical devices used by dermatologists. In contrast, plastic surgeons use liposuction machines, skin graft mesher, pacific shower trolley, hand held doppler, etc.

CDSCO classification for dermatological and plastic surgery medical devices

CDSCO has classified medical devices based on risk level and intended use. This CDSCO classification system helps simplify the medical device registration process. Each medical device has its own set of regulations depending on the medical device class it belongs to. Like all other medical devices, dermatological and plastic surgery devices have also been classified based on their risk level and intended use.

Following list presents some examples of dermatological and plastic surgery medical devices belonging to various CDSCO classes:

• Class A: Occlusive wound dressing, plastic surgery osteotome, reusable dermatome blade, skin marker, surgical apparel, surgical guillotine, surgical lamp, non-powdered surgeon’s glove, eye pad, dermatome skin approximation tape, drape adhesive, hydrophilic wound dressing, internal tissue marker, laparoscopy tray, etc.
• Class B: Ultraviolet lamp for dermatologic disorders, wound auto fluorescence imaging device, battery-powered trephine system, cryosurgical unit and accessories, dermal dilator, electrically- powered trephine system, electrosurgical device for over- the- counter aesthetic use, gas-powered dermatome, removable skin clip, removable skin staple, etc.
• Class C: Implantable ligating clip, laser surgical instrument for general, plastic surgery, and dermatology use, carbon dioxide laser, electrosurgical cutting and coagulation device, general electrosurgical unit, implantable staple, copper vapour laser, etc.

CDSCO has published an exhaustive list of dermatological and plastic surgery devices (approximately 55 devices) categorised based on class. The full list of CDSCO classification of devices intended for dermatological and plastic surgery use is available here.

Licensing authorities and requirements

Depending on the CDSCO class, different authorities will be responsible for registering dermatological and plastic surgery devices in India.

Central Licensing Authority (CLA): CLA is responsible for Class C and D medical devices intended for dermatological and plastic surgery use

State Licensing Authority (SLA): SLA is responsible for Class A and B medical devices intended for dermatological and plastic surgery use

For Class A and B dermatological and plastic surgery devices, MD 5 License will be required. However, for Class C and D dermatological and plastic surgery devices, MD 9 License will be required. For importing dermatological and plastic surgery devices into India, MD15 Import License will be required. The licenses will remain valid indefinitely as long as they are not cancelled by the regulatory body officials. However, a license retention fee is to be paid every 5 years.

Importance of CDSCO registration for dermatological and plastic surgery medical devices

CDSCO registration for dermatological and plastic surgery devices is mandatory for marketing them in India. Although this is a regulatory requirement, the CDSCO registration is beneficial for both manufacturers and healthcare professionals. It is aimed at preventing poor quality medical devices from entering the Indian market. It safeguards patients and healthcare professionals alike.

Following are the benefits for manufacturers, healthcare professionals, patients, and dermatology and plastic surgery sector:

• For dermatological and plastic surgery medical device manufacturing companies, the CDSCO registration indicates their commitment to patient safety. Only with proper CDSCO registration can manufacturers enter the dermatology and plastic surgery medical device market in India.
• For healthcare professionals, CDSCO registration guarantees them that they are using safe and effective dermatological and plastic surgery devices. This helps them to provide better treatment, thereby leading to improved patient outcomes. The healthcare professionals can rest assured that they are using devices that comply with regulatory standards. The risk of complications caused by faulty devices can be avoided.
• For patients, CDSCO registration is an assurance that the devices being used to treat them are of the highest quality. They can rest easy that they have the best possible chance of recovery.
• CDSCO registration indicates transparency and accountability in the medical devices sector. It guarantees all medical devices in the Indian market comply with the regulatory requirements for safety and efficacy. The goal is to protect public health and ensure effective healthcare delivery. For dermatology and plastic surgery, it is of utmost importance that medical devices are of highest quality and safety standards.

Necessary documents for registration

Certain supporting documents are required for registering your devices for dermatological and plastic surgery use in India.

• Sale Deed / Rent Deed proving legal ownership of the manufacturing facility.
• Building layout presenting the dimensions of each room and the location of all the equipment in the manufacturing facility. This is basically a detailed drawing of the medical device manufacturing facility.
• Organization identity proof, such as UDYAM Aadhar, PAN card, etc.
• Documents proving the manufacturing team comprises competent, qualified, and experienced staff who will manufacture and test the devices.
• Plant master file
• Device master file
• Audit reports
• ISO 13485 certificate demonstrating the manufacturing facility meets international standard for quality management systems.
• Medical device test license. This will be required in case you need to test your product for dermatological and plastic surgery use before launching it in India.
• Certificate of Analysis of 3 Consecutive Batches. This document will certify that the first 3 batches of the manufactured dermatological and plastic surgery devices meet the required quality criteria.
• Document supporting compliance with the applicable environmental regulatory requirements.

The above list provides an outline of the documents required for registering medical devices intended for dermatology and plastic surgery. For the exact list of documents and document preparation support, the Pharmadocx Consultants team is ready to help you.

Process for registration for dermatological and plastic surgery medical devices in India

The application process for registering medical devices for dermatology and plastic surgery is online on the CDSCO website.

1. Login/Signup on CDSCO’s online registration portal.
2. Prepare the application as per the requirements of the CDSCO dermatological and plastic surgery device class.
3. Collate the necessary supporting documents required for registration.
4. Submit the application online and pay the required registration fees.
5. The regulatory officials will review and evaluate your application.
6. The regulatory officials will perform an audit and inspect the manufacturing facility as per regulatory requirements.
7. If all the necessary criteria are fulfilled, CDSCO will grant the pertinent license. This will permit you to manufacture, sell, and distribute dermatological and plastic surgery medical devices in India.

Do you want to register your dermatological and plastic surgery medical devices in India?

Look no beyond. You have landed in the right place. Understanding the CDSCO regulations for medical devices intended for dermatological and plastic surgery use can be arduous. The Pharmadocx Consultants team is dedicated to simplify your path to securing the CDSCO registration. We provide support in the following areas:

• Document preparation
• License application
• Mock audit and preparation for audit
• Query response and license grant

Manufacturing medical devices intended for dermatological and plastic surgery use is a lucrative business. However, to enter the Indian medical device manufacturing sector, you have to register your product with the CDSCO. The Pharmadocx Consultants team will help you obtain the registration for dermatological and plastic surgery medical devices in India. Our team provides tailored support depending on your needs and will guide you through the registration process. Simply call/Whatsapp us at 9996859227 or drop an email at [email protected] to get your CDSCO registration process started.