Regulation/Guidelines

Drug Controller General of India (DCGI) Classifies 55 Medical Devices Pertaining to Dermatology and Plastic Surgery

  • 11th October, 2021
Drug Controller General of India (DCGI) classifies 55 medical devices pertaining to Dermatology and Plastic Surgery

The Central Drugs Standards Control Organization (CDSCO) has recently released a notification on 26th July 2021 for the classification of medical devices used in the Dermatological and Plastic Surgery under the provisions of Medical Device Rules (MDR) 2017.

This list includes a total of 55 medical devices which have been categorized into three classes: A, B, and C. This risk classification has been done according to the intended use, the risk associated with the device and several other parameters stated in the First Schedule of MDR 2017.

Quality, safety, and the performance of these medical devices are regulated under the provisions stated in the Drugs and Cosmetics Act, 1940 and rules related to it. This list is subjected to revisions from time to time

Table of Classification of Medical Devices used in Dermatological and Plastic Surgery:

Medical Devices Classified as Low Risk: Risk Class A 
NoMedical DevicesIntended Use 
1)Surgical camera & accessories Record operative procedures
2)Non-powdered surgeon’s glovePrevent contamination of the surgical wound 
3)DermatomeSurgical knife to harvest the skin for grafting 
4)Drape adhesiveAttach a surgical drape on the skin
5)Dermatome skin approximation tape Collect skin graft tissue and intended for single-use 
6)Eye padEye bandage for protection and absorption of secretions
7)Hydrophilic wound dressingTo cover wound and absorb exudate 
8) Internal tissue markerDemarcate selected sites on internal tissues,before and during general surgical procedures 
9)Laparoscopy Tray Single-use tray to perform a laparoscopic procedure
10)Manual operating table, chair, & accessoriesSupport patient during surgical examinations or procedures
11)Manually-operated dermatome Surgical device for severing a thin piece of skin for grafting, or  resection of small skin lesion
12)Occlusive wound dressingCover a wound, provides a moist wound environment, and allows exchange of gases through the device 
13)Plastic surgery osteotome Surgical instrument for cutting and shaping small bones and cartilage during plastic surgery 
14)Reusable dermatome blade Harvest the skin graft
15)Skin markerMark the patient skin for surgical incision and anatomical sites 
16)Surgical apparelPrevent transfer of microbes, body fluids, and particulate 
17)Surgical guillotine Cutter for severing a skin tissue
18)Surgical lamp For illuminating surgical field or patient
19)Surgical microscope and accessoriesMagnification of surgical field 
Medical Devices Classified as Low Moderate Risk: Risk Class B
21)Organ bagPreserve organ during surgical procedures to prevent moisture loss 
21)Low energy ultrasound wound cleaner Clean and maintain debridement of wounds
22)Surgical drape and drape accessoriesIsolate surgical incision site and prevent it from microbial and other contamination
23)Suture retention deviceAid wound healing by distributing suture tension over a larger area in the patient 
24)Ultraviolet lampProvide UV rays to photo activate a labeled drug and adequate directions for the device use attached with the drug in treating dermatologic disorder 
25)Wound autofluorescence imaging device View autofluorescence images from skin wounds 
26)Battery-powered trephine system Remove the intervertebral disc, hard tissues, or soft tissues
27)Colonoscope, General & Plastic Surgery Remove foreign bodies, excision of tumors or colorectal polyps, and control hemorrhage
28)Cryosurgical unit & accessories Destroy tissue during surgical procedures by applying extreme cold temperature
29)Dermal dilator Temporary implantable device for dilation of surrounding devices
30)Electrically- powered trephine system Rotary surgical device for removing the intervertebral disc, hard-soft tissues, or soft tissues
31)Electrosurgical device for over-the-counter aesthetic use Produces localized heating within tissues for non-invasive aesthetic use
32)Esophagoscope, General & Plastic Surgery Visual examination, diagnosis, and treatment of  esophagus
33)Gas-powered dermatome Cut a thin piece of skin for grafting, or resection of a small skin lesion. 
34)Gas-powered surgical saw Generate vibration or reciprocal movements 
35)Gas-powered trephine system Rotary surgical device for removal of intervertebral disc, hard tissues, or soft tissues
36)Gastroscope, General & Plastic Surgery Isolate tissue samples by inserting instruments such as small pincers
37)Hemostatic knife Surgical severing instrument for transmitting heat directly to body tissues for achieving hemostasis
38)Irrigating wound retractor device. Retract the surgical incision, isolate and irrigate surgical wound, and serve as a conduit for removal of fluid from wound 
39)Laparoscope, General & Plastic Surgery Monopolar electrosurgical cutting and coagulation in minimally invasive surgical procedures 
40)Liposuction catheter Remove fatty deposits and intended for single use only
41)Powered corneal trephine Electric cylindrical device for removal of ring-shaped piece of corneal tissue in ophthalmic surgery 
42)Powered dermatome Remove fragments of damaged skin or thin slicing of donor skin for a skin graft
43)Powered suction pumpRemove infectious materials from wounds or fluids from a patient’s airway or respiratory support system
44)Removable skin clip Connect skin tissues temporarily for healing
45)Removable skin staple Connect external tissues temporarily for healing
46)Single-use dermatome blade Collect skin grafts and intended for single-use
47)Skin Stapler Applied to close lacerations on the outer layer of the dermis for healing
48)Soft tissue trephine Coronary or cylindrical saw for resecting discs of tissues other than bones
Medical Devices Classified as High Moderate Risk: Risk Class C
49)Implantable ligating clip Connect internal tissues for healing 
50)Laser surgical instrument Cut, destroy, or remove tissue by light energy 
51)Carbon dioxide laser Used in surgical procedures including gynecology, neuroscience, dermatology
52)Copper vapor laser Treat cutaneous vascular lesions in dermatology
53)Electrosurgical cutting & coagulation device Remove tissue and control bleeding by using high-frequency electrical current
54)General electrosurgical unit For confirming that an incision is made as desired, micro/macroscopically
55)Implantable staple Connect internal tissues for healing

Reference:

Medical Devices and Diagnostics. CDSCO (India). Available from: https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/ {Last accessed: 14 Aug, 2021}