This article deals with the latest rules of Dermatology and Plastic Surgery as a Medical Device in India-Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for Dermatology and Plastic Surgery and Medical Device in India. All Dermatology and Plastic Surgery Products now need to be registered in order to comply with the latest Medical Device Rules in India ( i.e 30th September, 2021). Below is a table which helps manufacturers classify their products and apply with the Indian Health Ministry Accordingly. The total number of Devices classified are 55.
Table: Dermatology and Plastic Surgery as Medical Device India
| Sr.No. | Medical DeviceName | Intended Use | Risk Class |
| 1 | Organ bag. | An organ bag is a device that is a flexible plastic bagintended to be used as a temporary receptacle for anorgan during surgical procedures to prevent moistureloss. | B |
| 2 | Surgical cameraand accessories. | A surgical camera and accessories is a deviceintended to be used to record operative procedures. | A |
| 3 | Implantableligating clip | An implantable clip is a clip-like device intended toconnect internal tissues to aid healing. It is notabsorbable. | C |
| 4 | Laser surgicalinstrument for usein general andplastic surgery andin dermatology. | A carbon dioxide laser for use in general surgery andin dermatology is a laser device intended to cut,destroy, or remove tissue by light energy emitted bycarbon dioxide. | C |
| 5 | Low energyultrasound woundcleaner | A low energy ultrasound wound cleaner is a devicethat uses ultrasound energy to vaporize a solution andgenerate a mist that is used for the cleaning andmaintenance debridement of wounds. | B |
| 6 | Non-powderedsurgeon’s glove. | A non-powdered surgeon’s glove is a device intendedto be worn on the hands of operating room personnelto protect a surgical wound from contamination | A |
| 7 | Surgical drapeand drapeaccessories | A surgical drape and drape accessories is a devicemade of natural or synthetic materials intended to beused as a protective patient covering to isolate a siteof surgical incision from microbial and othercontamination. | B |
| 8 | Suture retentiondevice | A suture retention device is a device, such as aretention bridge, a surgical button, or a suture bolster,intended to aid wound healing by distributing suturetension over a larger area in the patient | B |
| 9 | Ultraviolet lampfor dermatologicdisorders. | An ultraviolet lamp for dermatologic disorders is adevice (including a fixture) intended to provideultraviolet radiation of the body to photo activate adrug in the treatment of a dermatologic disorder if thelabeling of the drug intended for use with the devicebears adequate directions for the device’s use withthat drug. | B |
| 10 | Wound autofluorescenceimaging device | A wound auto fluorescence imaging device is a toolto view auto fluorescence images from skin woundsthat are exposed to an excitation light. The device isnot intended to provide quantitative or diagnosticinformation. | B |
| 11 | Battery-poweredtrephine system | A rotary surgical device consisting of a motor (anengine) and a cylindrical or trephine insertion portion.It usually has an extremely sharp-edged saw blade ora cutting blade with a thin saw blade. The blade isbeveled on one side. It is used for removal of theintervertebral disc, other hard tissues, or soft tissues.It may have a speed control device. This is a battery-driven device | B |
| 12 | Carbon dioxidelaser | A gas laser that is used in surgical procedures. Itutilizes carbon dioxide as the substrate. It is widelyused in several clinical fields (e.g., gynecology,neuroscience, dermatology). | C |
| 13 | Colonoscope,General & PlasticSurgery | Colonoscopes are used for the removal of foreignbodies, excision of tumors or colorectal polyps(polypectomy), and control of hemorrhage. Routinecolonoscopy is important in diagnosing intestinalcancer | B |
| 14 | Copper vapourlaser | A gas laser used in surgical procedures, etc. It utilizescopper vapor as the substrate. It is used indermatology, etc. for treatment of cutaneous vascularlesions (e.g., port-wine stains, telangiectasia). | C |
| 15 | Cryosurgical unitand accessories | A cryosurgical unit with a liquid nitrogen cooledcryoprobe and accessories is a device intended todestroy tissue during surgical procedures by applyingextreme cold. | B |
| 16 | Dermal dilator | A device to be temporarily implanted subcutaneouslyto dilate the surrounding skin. Usually, a balloon isimplanted subcutaneously where solutions includingsaline solution are infused. | B |
| 17 | Dermatome | A surgical knife used to harvest the skin for grafting.Either manual or electric-powered. | A |
| 18 | Dermatome skinapproximation tape | A tape that comes in various sizes with adhesive onboth sides. It is attached onto a skin graft knife tocollect a skin graft tissue. This device is for single-use. | A |
| 19 | Drape adhesive. | A drape adhesive is a device intended to be placed onthe skin to attach a surgical drape. | A |
| 20 | Electrically-powered trephinesystem | A rotary surgical device consisting of a motor (anengine) and a cylindrical or trephine insertionportion. The blade is beveled on one side. It is usedfor removal of the intervertebral disc, other hard softtissues, or soft tissues. | B |
| 21 | Electrosurgicalcutting andcoagulationdevice and | Electrosurgical cutting and coagulation device andaccessories is a device intended to remove tissueand control bleeding by use of high-frequencyelectrical current. | C |
| 22 | Electrosurgicaldevice for over-the- counteraesthetic use | An electrosurgical device for over-the-counteraesthetic use is a device using radiofrequency energyto produce localized heating within tissues for non-invasive aesthetic use. | B |
| 23 | Esophagoscope,General & PlasticSurgery | An endoscope used for visual examination,diagnosis, and treatment of the esophagus. Theinsertion section changes its shape corresponding tothe shape of the body cavity. The device is insertedthrough the oral cavity. | B |
| 24 | Eye pad. | An eye pad is a device that consists of a pad made ofvarious materials, such as gauze and cotton, intendedfor use as a bandage over the eye for protection orabsorption of secretions. | A |
| 25 | Gas-powereddermatome | A gas pressure-operated surgical device used to cut athin piece of skin for grafting, or to resect a small skinlesion. A dedicated blade is required for this purpose. | B |
| 26 | Gas-poweredsurgical saw | A saw has a handpiece with an attachment thatgenerates vibration or reciprocal movements. It adoptseither a micro or macro design. Rechargeablebatteries are used. Usually, compressed air orcompressed nitrogen is used. | B |
| 27 | Gas-poweredtrephinesystem | A rotary surgical device consisting of a motor (anengine) and a cylindrical or trephine insertion portion.It usually has an extremely sharp-edged saw blade ora cutting blade with a thin saw blade. The blade isbeveled on one side. It is used for removal of theintervertebral disc, other hard tissues, or soft tissues.It may have a speed control device. This is a gas-driven device. | B |
| 28 | Gastroscope,General &Plastic Surgery | A gastroscope is a flexible tube that has a small lightand a video camera attached to the end of it. Thetube can be used to take tissue samples by insertinginstruments such as small pincers. | B |
| 29 | Generalelectrosurgicalunit | A device accompanied by accessories thatcuts/coagulates tissues with a high-frequency currentor with the electricity/heat of the heating element. Thedevice is used by a physician to confirm that anincision or coagulation is made as intended,macroscopically or microscopically. | C |
| 30 | Hemostatic knife | A surgical severing instrument that is similar to ascalpel, excluding the fact that its blade is designed tobe heated with an electric current. The blade transmitsheat directly to body tissues to achieve hemostasis.The instrument uses thermal energy for the purposeand requires no grounding pad. | B |
| 31 | Hydrophilic wounddressing. | A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and toabsorb exudate. It consists of nonresorbablematerials with hydrophilic properties that arecapable of absorbing exudate (e.g., cotton, cottonderivatives, alginates, dextran, and rayon). | A |
| 32 | Implantable staple | An implantable staple is a staple-like device intendedto connect internal tissues to aid healing. | C |
| 33 | Internal tissuemarker. | An internal tissue marker is a prescription use devicethat is intended for use prior to or during generalsurgical procedures to demarcate selected sites oninternal tissues. | A |
| 34 | Irrigatingwoundretractordevice. | An irrigating wound retractor device is a prescriptiondevice intended to be used by a surgeon to retractthe surgical incision, to provide access to the surgicalwound, to protect and irrigate the surgical wound, andto serve as a conduit for removal of fluid from thesurgical wound | B |
| 35 | Laparoscope,General &Plastic Surgery | “These electrodes are intended for use in minimallyinvasive surgical procedures where monopolarelectrosurgical cutting and coagulation are desired | B |
| 36 | LaparoscopyTray | Laparoscopy Tray is intended for single-use toenable a suitable trained health care professional toperform an laparoscopic procedure. | A |
| 37 | Liposuctioncatheter | A rigid tube inserted into the subcutaneous layertransdermally for removal of fatty deposits.Aspiration is performed with an appropriate unit.This device is for single-use. | B |
| 38 | Manual operatingtable andaccessories andmanual operatingchair andaccessories | A manual operating table and accessories and amanual operating chair and accessories are non-powered devices, usually with movable components,intended to be used to support a patient duringdiagnostic examinations or surgical procedures. | A |
| 39 | Manually-operateddermatome | A hand-held surgical device used to sever a thinpiece of skin for grafting, or to resect a small skinlesion. A dedicated blade is required for this purpose. | A |
| 40 | Occlusive wounddressing. | An occlusive wound dressing is a nonresorbable,sterile or non-sterile device intended to cover awound, to provide or support a moist woundenvironment, and to allow the exchange of gasessuch as oxygen and water vapor through the device. | A |
| 41 | Plastic surgeryosteotome | A surgical, chisel-like, instrument designed to cutand/or shape small bones and/or cartilage duringplastic surgery. It is hand-held by the surgeon whowill typically use a surgical mallet or hammer tomanually impart an impacting force to the proximalend of the instrument. | A |
| 42 | Powered cornealtrephine | An electric cylindrical device for ophthalmic surgeryequipped with a blade for resection/removal of a ring-shaped piece of corneal tissue (corneal button). Forexample, when a healthy corneal graft is obtainedfrom a cadaver, the recipient’s morbid cornea isresected and removed to allow transplantation of thegraft. | B |
| 43 | Powereddermatome | An electric surgical device used for removal of thefragment of damaged skin or for thinly slicing the skinof a donor for skin graft. A dedicated blade should beused for these purposes. | B |
| 44 | Powered suctionpump. | A powered suction pump is a portable, AC-poweredor compressed air-powered device intended to beused to remove infectious materials from wounds orfluids from a patient’s airway or respiratory supportsystem. The device may be used during surgery inthe operating room or at the patient’s bedside. Thedevice may include a microbial filter | B |
| 45 | Removable skinclip | A removable skin clip is a clip-like device intended toconnect skin tissues temporarily to aid healing. It isnot absorbable | B |
| 46 | Removable skinstaple | A removable skin staple is a staple-like deviceintended to connect external tissues temporarily to aidhealing. It is not absorbable. | B |
| 47 | Reusabledermatomeblade | A blade that comes in various sizes, attached to theskin graft knife, and is used to harvest the skin graft.This device is reusable after sterilization. Usually, theblade point should be sharpened periodically. | A |
| 48 | Single-usedermatome blade | A blade, available in various sizes, attached to adermatome for collection of skin grafts. The device isintended for single-use. | B |
| 49 | Skin marker | A skin marker is a pen-like device intended to beused to write on the patient’s skin, e.g., to outlinesurgical incision sites or mark anatomical sites foraccurate blood pressure measurement. | A |
| 50 | Skin Stapler | Skin Stapler is intended to be applied to closelacerations on the outer layer of the dermis. | B |
| 51 | Soft tissue trephine | A cylindrical or coronary saw used to resectdiscs of tissues other than bones. It comes invarious sizes and configurations according tothe size and hardness of the tissue to beresected. | B |
| 52 | Surgicalapparel. | Surgical apparel are devices that are intended to beworn by operating room personnel during surgicalprocedures to protect both the surgical patient and theoperating room personnel from transfer ofmicroorganisms, body fluids, and particulate | A |
| 53 | Surgical guillotine | A cutter that consists of a metal frame. The cutterslides through the frame. It comes in variousconfigurations and sizes according to the type oftissue to be severed. Various cranks or shaft drivermechanisms generate the power. | A |
| 54 | Surgical lamp | Identification. A surgical lamp (including a fixture) isa device intended to be used to provide visibleillumination of the surgical field or the patient. | A |
| 55 | Surgicalmicroscope andaccessories. | A surgical microscope and accessories is an AC-powered device intended for use during surgery toprovide a magnified view of the surgical field. | A |
Conclusion:
The above article is taken from S.O 648(E) & G.S.R 102(E) which mentions that all Medical Devices will be regulated in a phase manner. The CDSCO has classified the MDR in India as Appendix A based on the Intended Use, Risks Associated and Other Parameters Specified with the device. The above table has the general intended use against each device, however if any specific intended use for a particular device, it has to be mentioned by the manufacturer. The list is dynamic and is subject to changes. To obtain MDR in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Dermatology and plastic surgery as a Medical Device India. In order to comply with the deadline 30th September of Dermatology and Plastic Surgery as a Medical Device in India contact us at admin@morulaa.com. You can also subscribe to our website to learn about the Latest Rules and Medical Regulations.
Leave a reply
You must be logged in to post a comment.