Dermatological and Plastic Surgery Medical Devices[In-depth Info]

Manufacturers and Importers of dermatological and plastic surgery medical devices must comply with the rules of the Central Drugs Standard Control Organization (CDSCO) to market their products in India. In its absence, the safety, quality, and performance of these devices cannot be ascertained. As a result, you don’t get the license to sell them. For medical devices classified as Class A or B, the manufacturing license is issued by the State Licensing Authority (SLA), while for Class C and D devices, it is issued by the Central Drugs Standard Control Organization (CDSCO). However, for the import of devices across all classes (A, B, C, and D), the Central Drugs Standard Control Organization (CDSCO) is the responsible authority.

In this post, we’ll explain the whole process for obtaining the Medical Device license for Dermatological and Plastic Surgery devices and how Dueran Consultant helps make it seamless.

Table of Contents

What is a CDSCO Medical Device License for Dermatological and Plastic Surgery Devices?

A Medical Devices license for Dermatological and Plastic Surgery devices is a mandatory approval from the Central Drugs Standard Control Organization or the concerned State Licensing Authority. This means that you can manufacture, import, sell, and distribute medical devices used in dermatological and plastic surgery in India after obtaining the required approval. This approval means that you are compliant with the Medical Device Rules, 2017. Doing so ensures that your device is safe and efficient for the intended user.

CDSCO Classification of Dermatological and Plastic Surgery Devices

To obtain a CDSCO medical device license, knowing device classification is significant. The four categories include Class A, B, C, and D, and each is based on the level of risk and intended use. The table below shows dermatological and plastic surgery Medical devices classification and their respective issuing licensing authority.

Type of License	Device Class	Risk Level	Licensing Authority	Required Licenses
Manufacturing License	Class A and B	Low to Moderate	State Licensing Authority (SLA)	Form MD 5/ Form MD 6
Manufacturing License	Class C and D	Moderate to High	CDSCO (Central Licensing Authority)	Form MD 9/ Form MD 10
Import License	Class A/B/C/D	Low to High	CDSCO (Central Licensing Authority)	Form MD 15

Classification of Medical Devices Pertaining to Dermatological & Plastic Surgery

All the products used in various clinical procedures related to dermatological and plastic surgery are classified as follows:

S No.	Medical Device Name	Risk Class
1	Organ bag	B
2	Surgical camera and accessories	A
3	Implantable ligating clip	C
4	Laser surgical instrument for use in general and plastic surgery and in dermatology	C
5	Low-energy ultrasound wound cleaner	B
6	Non-powdered surgeon’s glove	A
7	Surgical drape and drape accessories	B
8	Suture retention device	B
9	Ultraviolet lamp for dermatologic disorders	B
10	Wound auto fluorescence imaging device	B
11	Battery-powered trephine system	B
12	Carbon dioxide laser	C
13	Colonoscope, General & Plastic Surgery	B
14	Copper vapour laser	C
15	Cryosurgical unit and accessories	B
16	Dermal dilator	B
17	Dermatome	A
18	Dermatome skin approximation tape	A
19	Drape adhesive	A
20	Electrically powered trephine system	B
21	Electrosurgical cutting and coagulation device	C
22	Electrosurgical device for over-the-counter aesthetic use	B
23	Esophagoscope, General & Plastic Surgery	B
24	Eye pad	A
25	Gas-powered dermatome	B
26	Gas-powered surgical saw	B
27	Gas-powered trephine system	B
28	Gastroscope, General & Plastic Surgery	B
29	General electrosurgical unit	C
30	Hemostatic knife	B
31	Hydrophilic wound dressing	A
32	Implantable staple	C
33	Internal tissue marker	A
34	Irrigating wound retractor device	B
35	Laparoscope, General & Plastic Surgery	B
36	Laparoscopy Tray	A
37	Liposuction catheter	B
38	Manual operating table and accessories, and manual operating chair and accessories	A
39	Manually-operated dermatome	A
40	Occlusive wound dressing	A
41	Plastic surgery osteotome	A
42	Powered corneal trephine	B
43	Powered dermatome	B
44	Powered suction pump	B
45	Removable skin clip	B
46	Removable skin staple	B
47	Reusable dermatome blade	A
48	Single-use dermatome blade	B
49	Skin marker	A
50	Skin Stapler	B
51	Soft tissue trephine	B
52	Surgical apparel	A
53	Surgical guillotine	A
54	Surgical lamp	A
55	Surgical microscope and accessories	A

Types of Licenses for Dermatological and Plastic Surgery Medical Devices in India

Licensing requirements differ according to your needs. Specific licenses are required by the manufacturers and importers, depending upon the class of your device.

Form MD-5 & Form MD-6 license is a prerequisite for producing or manufacturing Class A and B dermatological and plastic surgery devices, which is issued by the State Licensing Authority.
Form MD-9 & Form MD-10 license, issued by CDSCO, is for producing Class C and D devices.
Foreign manufacturers who want to import products in India should first submit Form MD-14. A successful review of this form will get you the approval in the form of the MD 15 import license for all Classes of Medical devices (Class A, B, C, and D).

Process for Dermatological and Plastic Surgery Medical Devices License Approval

To obtain a medical device license, you must first determine its risk class and then prepare the necessary documents in the correct format. If you need guidance or assistance at any step, our team at Dueran Consultant is here for you.

1. Device Identification & Classification

Verify if your device is notified or non-notified (i.e., not strictly regulated by the CDSCO). Then, classify the device (A, B, C, or D) based on risk and intended usage.

2. Appointment of Indian Authorized Agent (IAA)

For foreign manufacturers, an IAA represents you in India. The IAA must have the Wholesale license or registration Certificate (Form MD-42) for selling the device. Additionally, the authorisation you grant to the IAA must be documented by a power of attorney.

3. Documentation Preparation

Preparing documents is the most significant step in obtaining the CDSCO License for dermatological and plastic surgery devices. It is a lengthy and meticulous process that is prone to errors. The following documents are essential:

Application Form (With product and applicant details)
Challan TR6 (Fee payment proof)
ISO 13485 Certificate (Quality Management System Certificate)
Power of Attorney (For foreign manufacturers)
Required Undertakings as per Medical Devices Rules, 2017
CE Certificate (if applicable)
Free Sale Certificate
Plant Master File & Device Master File

4. Online Application Submission

After preparing the documents, visit the CDSCO Medical Device SUGAM Portal. Register on the site with a valid email and confirm it via the link sent to your email. This will activate your account, and the verification process will begin. After verification, submit the relevant forms on the portal and upload all required documents.

5. Application Review & Audit

CDSCO reviews the application you have submitted. It will also conduct a facility audit. If it identifies any Non-Conformance (NC) issues, you must address them.

6. Grant of License

Upon successful review, CDSCO will issue the license, which remain valid in perpetuity, unless it has been cancelled or surrendered, provided the licence holder deposits the licence retention fee every five years.

Fee for CDSCO License for Plastic Surgery and Dermatological Products

The Government fee for Class A and B medical devices for domestic manufacturers is Rs. 5,000 for one site and Rs. 500 for each medical device.
The Government fee for Class C and D medical devices for domestic manufacturers is Rs. 50,000 for one site and Rs. 1,000 for each medical device.
The Government fee for an Import License of Class A medical devices is USD 1,000 for one Foreign manufacturing site and USD 50 for each medical device.
The Government fee for an Import License of Class B medical devices is USD 2,000 for one Foreign manufacturing site and USD 1,000 for each medical device.
The Government fee for Import License of Class C & D medical devices is USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.

Steps for Manufacturers & Importers for Registering on the CDSCO Medical Devices Sugam Portal

The process for registration is as follows:

On your browser, go to https://cdscomdonline.gov.in/NewMedDev/Homepage
Tap the registration link from the portal.
Use a valid email ID and contact number to register.

Submit the following documents:

Your ID proofs
An Affidavit
Your corporate address proofs
A copy of your manufacturing or wholesale licenses.
Validate registration via OTP.
Now, you can log in and start your application process.

Recent Changes in CDSCO Guidelines

This year, CDSCO has put in place some new processes for manufacturers and importers of medical devices. These include:

System auto-generated Neutral Code: Manufacturers with a valid license can get a Neutral Code for export, directly via the Medical Devices Online Portal. It eased up with the earlier manual issuance method set up by the Licensing Authority.
Auto-generation of Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC): The new auto-generation mechanism for MSC and NCC certificates for licensed medical devices. If you have applied through the previous portal, you must reapply to get the auto-generated certificates.
Re-classification of risk class: Many devices have undergone risk re-classification. Review the updated table for reclassified devices given earlier in this post.

How Dueran Consultant Helps with the Smooth CDSCO Licensing Process

Challenges with the classification of devices, documentation, and keeping updated with the rules of CDSCO are common for importers and manufacturers. We provide customised regulatory solutions to help you get the license without delay. Beyond solving typical issues, we also create a regulatory strategy to open up potential opportunities for you to sell and grow your brand in India.

How to Get CDSCO Dermatological & Plastic Surgery Medical Devices License