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.
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 | ||
| No | Medical Devices | Intended Use |
| 1) | Surgical camera & accessories | Record operative procedures |
| 2) | Non-powdered surgeon’s glove | Prevent contamination of the surgical wound |
| 3) | Dermatome | Surgical knife to harvest the skin for grafting |
| 4) | Drape adhesive | Attach a surgical drape on the skin |
| 5) | Dermatome skin approximation tape | Collect skin graft tissue and intended for single-use |
| 6) | Eye pad | Eye bandage for protection and absorption of secretions |
| 7) | Hydrophilic wound dressing | To cover wound and absorb exudate |
| 8) | Internal tissue marker | Demarcate 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, & accessories | Support 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 dressing | Cover 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 marker | Mark the patient skin for surgical incision and anatomical sites |
| 16) | Surgical apparel | Prevent 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 accessories | Magnification of surgical field |
| Medical Devices Classified as Low Moderate Risk: Risk Class B | ||
| 21) | Organ bag | Preserve 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 accessories | Isolate surgical incision site and prevent it from microbial and other contamination |
| 23) | Suture retention device | Aid wound healing by distributing suture tension over a larger area in the patient |
| 24) | Ultraviolet lamp | Provide 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 pump | Remove 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}
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