This article deals with the latest rules of Personal Use as 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 Personal Use and Medical Device in India. All Personal Use 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 32.
Table: Personal Use as Medical Device
| S.No. | Medical DeviceName | Intended Use | RiskClass |
| 1 | Garment,Protective forIncontinence | Intended to protect an incontinent patient’s garment from thepatient’s excreta. | A |
| 2 | Biosanitizer forMedical devices | Intended for surface disinfection of medical devices, nonporous hard-surfaces, medical-equipment, units, as well asin-depth cleaning of small surfaces. | B |
| 3 | Face shield | Intended to protect the wearer’s entire face (or part of it)from hazards such as chemical splashes (in laboratories orin industry), or potentially infectious materials (in medical andlaboratory environments). | A |
| 4 | Latex surgicalglove | Natural rubber based glove intended to protect the patientand wearer from cross infection when used in medical ordental surgery. | B |
| 5 | Non-latexsurgical glove | Synthetic material glove intended to protect the patient andwearer from cross infection when used in medical or dentalsurgery. | B |
| 6 | Radiationprotection gloves | A personal protection device that completely protects thehands of the operator and other personnel from unnecessaryexposure to primary radiation and scattered radiationassociated with diagnosis and therapeutic measures. | A |
| 7 | Partial handradiationprotector | A flat pad with straps or partial gloves that protect part ofhands and fingers from unnecessary exposure to primaryradiation and scattered radiation associated with diagnosisand therapeutic measures. | A |
| 8 | Radiationprotection apron | A standard length or half-length apron to protect the patient,the operator, and other personnel from radiation exposureduring a medical or dental procedure. Some have a fixed orremovable collar to protect the neck and thyroid. | A |
| 9 | Radiationprotection mitten | A personal protection device that protects the hands of theoperator and other personnel from unnecessary exposure toprimary radiation and scattered radiation associated withdiagnosis and therapeutic measures. The mittens are alsocalled mitts, and protect the thumb and other fingersindividually or together. | A |
| 10 | Radiationprotectiongoggles | A personal protection device that protects the eyes of theoperator and other personnel from unnecessary exposure toprimary radiation and scattered radiation associated withmedical/dental procedures for diagnosis and treatment. | A |
| 11 | Radiation faceprotector | A transparent or opaque personal protection device thatprotects the face and eyes of medical personnel and otherpersonnel from unnecessary exposure to primary radiationand scattered radiation associated with diagnosis andtreatment. | A |
| 12 | Operatorradiationprotectionspectacles | A personal protection device that protects the eyes of theoperator and other personnel from unnecessary exposure toprimary radiation and scattered radiation associated withdiagnosis and treatment.The device comes in non-correction(non-prescription) glasses and visual acuity correction(prescription) glasses. | A |
| 13 | Gonadalradiationprotector | A personal protection device that attenuates unnecessaryradiation exposure in diagnostic, medical or dentalprocedures, and shields the gonad of the patient and theoperator. | A |
| 14 | Radiationprotectionblanket | A personal protection device that protects specific body partsof the patient, operator, and other personnel fromunnecessary radiation exposure in medical/dentalprocedures for diagnosis and treatment. | A |
| 15 | Radiationprotection collar | A personal protection device that protects the neck or thyroidof the patient, the operator, and other personnel fromunnecessary radiation exposure in medical/dentalprocedures for diagnosis and treatment. | A |
| 16 | Radiationprotection cap | A personal protection device that protects the head of theoperator and other personnel from unnecessary exposure toprimary radiation and scattered radiation associated withmedical procedures for diagnosis and treatment. | A |
| 17 | Mobile radiationprotection barrier | A stand-alone, movable barrier that protects the operator etc.from unnecessary exposure to radiation used for medicaldiagnosis, treatment and dental procedures. | A |
| 18 | Non-latexmedicalexaminationglove | Gloves made of synthetic materials, and used to protect thepatient and users from cross infection during examination,check-up, treatment and handling of contaminated medicalmaterials except for surgery. | A |
| 19 | Latex medicalexaminationglove | Natural rubber gloves used to protect the patient and usersfrom cross infection during examination, check-up, treatmentand handling of contaminated medical materials except forsurgery. | A |
| 20 | chemotherapyspill clean-up kit | Designed to safely clean and dispose of Chemotherapy drugspills. | A |
| 21 | Medical/CadaverBody Bags | Intended for transporting a human corpse without any spreadof biohazard/infectious agent. | A |
| 22 | Surgical gown(Sterile) | A sterile garment made of natural and/or synthetic materialsintended for surgical procedures to help protect both thepatient and operating room personnel from the transfer ofmicroorganisms, body fluids, and particulate material. | B |
| 23 | Surgical gown(Non-Sterile) | A non-sterile garment made of natural and/or syntheticmaterials intended for surgical procedures to help protectboth the patient and operating room personnel from thetransfer of microorganisms, body fluids, and particulatematerial. | A |
| 24 | Isolation Gown)( Sterile) | A sterile garment made of natural and/or synthetic materialsintended to be worn by healthcare providers or visitors toisolate themselves from patients to protect the themselvesfrom a contagious agent which has infected the patient. | B |
| 25 | Isolation Gown(Non-Sterile) | A non-sterile garment made of natural and/or syntheticmaterials intended to be worn by healthcare providers orvisitors to isolate themselves from patients to protect thethemselves from a contagious agent which has infected thepatient. | A |
| 26 | Patient Gown | A garment made of natural and/or synthetic materials (e.g.,paper, cloth, plastic) intended to be worn by patients in aclinical setting (e.g., during hospitalization, duringexamination in a doctor’s office). A patient gown is usuallyshort-sleeved and may be closed by ties at the back/side ofthe garment. | A |
| 27 | ProfessionalExaminationGown | A garment made of natural and/or synthetic materialsintended to be worn by healthcare providers, sometimesover scrub suits, while examining patients. It can be fluidresistant or impervious to fluid. An examination gown is usedduring patient examination procedures to protect both thepatient and staff from the transfer of contaminants such asmicroorganisms or body fluids. | A |
| 28 | PersonalProtectiveEquipment | PPE kit used to acts as a barrier between infectiousmaterials such as viral and bacterial contaminants and skin,mouth, nose, or eyes. It refers to protective clothing,helmets, gloves, face shields, goggles, facemasks and/orrespirators or other equipment designed to protect thewearer from injury or the spread of infection or illness. | B |
| 29 | Surgical Helmet | Intended to protect healthcare workers from contaminants &debris on head. | A |
| 30 | Surgical Cap | Intended to protect face of patient & the operating roompersonnel from the transfer of micro-organisms, body fluids& particulate material. | A |
| 31 | Operating RoomShoes Cover | Intended to be worn by operating room personnel duringsurgical procedures to protect foot of both the surgicalpatient & the operating room personnel from transfer ofmicro-organisms, body fluids, and particulate material. | A |
| 32 | Surgical Drape &DrapeAccessories | A surgical drape & drape accessories is a device made ofnatural or synthetic materials intended to be used as aprotective patient covering to isolate a site of surgicalincision from microbial & other contamination. | B |
Conclusion:
The above table has the general intended use against each device, however if any specific intended use for a particular Personal Use, it has to be mentioned by the manufacturer, The list is dynamic and is subject to changes. To obtain MDR India for Personal Use as a Medical Device in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Personal Use as a Medical Device in India. We are a turnkey solution provider with an in-house Medical Device Consultancy team to conduct registrations of Medical Devices in India. In order to comply with the Deadline 30th September of Personal Use as a Medical Device in India contact us at [email protected]. You can also subscribe to our website to learn about the Latest Rules and Medical Regulations.