Introduction: Personal Protective Equipment Classification in India
Personal Protective Equipment (PPE) plays a critical role in safeguarding healthcare professionals, patients, and the general public from various health hazards. Under the Medical Device Rules 2017 in India, PPE is classified based on risk levels to ensure compliance with safety and regulatory standards.
As part of its continuous efforts to streamline the CDSCO medical device classification in India, the Central Drugs Standard Control Organization (CDSCO) has issued a new notification updating the classification of certain Personal Protective Equipment classification in India. These updates align India’s regulations with international best practices while ensuring a smooth medical device registration in India process.
India is Updating Existing Risk-Based Classifications for Personal Protective Equipment |
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As per the latest notification MED-16014(12)/1/2024-eOffice released on January 6th, 2025, 21 devices in this category have been reclassified from Class A to Class A (Self Notified). This change simplifies compliance for low-risk devices and aligns with the Updated CDSCO medical device rules in India framework. These updates play an importantrole in ensuring medical device compliance in India while providing a structured regulatory framework for manufacturers and healthcare providers. CDSCO has also updated the classification of other medical device categories, revising risk levels to reflect advancements in medical technology and regulatory requirements. You can view the full list of devices and their updated classifications in this document. |
Table: CDSCO Personal Protective Equipments Classification in India
The table below provides the updated classification for Personal Protective Equipment in India under the CDSCO medical device classification in India. The newly reclassified devices from Class A to Class A (Self Notified) have been highlighted as dark grey for easy identification.
| S.No. | Device name as per Medical Device Rules 2017 in India | Intended Use | RiskClass |
| 1 | Biosanitizer for Medical devices | Intended for surface disinfection of medical devices, nonporous hard-surfaces, medical-equipment, units, as well as in-depth cleaning of small surfaces. | B |
| 2 | Latex surgical glove | Natural rubber based gloves intended to protect the patient and wearer from cross infection when used in medical or dental surgery. | B |
| 3 | Non-latex surgical glove | Synthetic material glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery. | B |
| 4 | Non-latex medical examination glove | Gloves made of synthetic materials, and used to protect the patient and users from cross infection during examination,check-up, treatment and handling of contaminated medical materials except for surgery. | A |
| 5 | Latex medical examination glove | Natural rubber gloves are used to protect the patient and users from cross infection during examination, check-up, treatment and handling of contaminated medical materials except for surgery. | A |
| 6 | Surgical gown (Sterile) | A sterile garment made of natural and/or synthetic materials intended for surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | B |
| 7 | Surgical gown (Non-Sterile) | A non-sterile garment made of natural and/or synthetic materials intended for surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | A |
| 8 | Isolation Gown (Sterile) | A sterile garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect themselves from a contagious agent which has infected the patient. | B |
| 9 | Isolation Gown (Non-Sterile) | A non-sterile garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect the themselves from a contagious agent which has infected the patient. | A |
| 10 | Personal Protective Equipment | PPE kit used to act as a barrier between infectious materials such as viral and bacterial contaminants and skin,mouth, nose, or eyes. It refers to protective clothing,helmets, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. | B |
| 11 | Surgical Drape & Drape Accessories | A surgical drape & drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial & other contamination. | B |
| 12 | Protective garment for Incontinence | Intended to protect an incontinent patient’s garment from the patient’s excreta. | A (Self Notified) |
| 13 | 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 (Self Notified) |
| 14 | Radiation protection gloves | A personal protection device that completely protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. | A (Self Notified) |
| 15 | Partial hand radiation protector | A flat pad with straps or partial gloves that protect part of hands and fingers from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. | A (Self Notified) |
| 16 | Radiation protection apron | A standard length or half-length apron to protect the patient,the operator, and other personnel from radiation exposure during a medical or dental procedure. Some have a fixed or removable collar to protect the neck and thyroid. | A (Self Notified) |
| 17 | Radiation protection mitten | A personal protection device that protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. The mittens are also called mitts, and protect the thumb and other fingers individually or together. | A (Self Notified) |
| 18 | Radiation protection goggles | A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical/dental procedures for diagnosis and treatment. | A (Self Notified) |
| 19 | Radiation face protector | A transparent or opaque personal protection device that protects the face and eyes of medical personnel and other personnel from unnecessary exposure to primary radiationand scattered radiation associated with diagnosis andtreatment. | A (Self Notified) |
| 20 | Operator radiation protection spectacles | A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated withdiagnosis and treatment.The device comes in non-correction(non-prescription) glasses and visual acuity correction(prescription) glasses. | A (Self Notified) |
| 21 | Gonadal radiation protector | A personal protection device that attenuates unnecessary radiation exposure in diagnostic, medical or dental procedures, and shields the gonad of the patient and the operator. | A (Self Notified) |
| 22 | Radiation protection blanket | A personal protection device that protects specific body parts of the patient, operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment. | A (Self Notified) |
| 23 | Radiation protection collar | A personal protection device that protects the neck or thyroid of the patient, the operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment. | A (Self Notified) |
| 24 | Radiation protection cap | A personal protection device that protects the head of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical procedures for diagnosis and treatment. | A (Self Notified) |
| 25 | Mobile radiation protection barrier | A stand-alone, movable barrier that protects the operator etc.from unnecessary exposure to radiation used for medical diagnosis, treatment and dental procedures. | A (Self Notified) |
| 26 | chemotherapy spill clean-up kit | Designed to safely clean and dispose of Chemotherapy drugspills. | A (Self Notified) |
| 27 | Medical/Cadaver Body Bags | Intended for transporting a human corpse without any spread of biohazard/infectious agent. | A (Self Notified) |
| 28 | 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 usually short-sleeved and may be closed by ties at the back/side of the garment. | A (Self Notified) |
| 29 | Professional Examination Gown | A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. | A (Self Notified) |
| 30 | Surgical Helmet | Intended to protect healthcare workers from contaminants &debris on head. | A (Self Notified) |
| 31 | Surgical Cap | Intended to protect face of patient & the operating room personnel from the transfer of micro-organisms, body fluids& particulate material. | A (Self Notified) |
| 32 | Operating Room Shoes Cover | Intended to be worn by operating room personnel during surgical procedures to protect foot of both the surgicalpatient & the operating room personnel from transfer ofmicro-organisms, body fluids, and particulate material. | A (Self Notified) |
Conclusion: Medical Device Compliance in India for Personal Protective Equipment
This article is based on notifications 29/MiscJ03/2020-DC (186) and MED-16014(12)/1/2024-eOffice, which outline the regulatory requirements for Personal Protective Equipment classification in India. The CDSCO medical device classification in India provides a structured framework that considers the intended use, associated risks, and device-specific parameters.
The classification system is dynamic and subject to periodic updates to align with global standards. For expert guidance on medical device registration in India, contact Morulaa. Our in-house consultancy team offers end-to-end solutions to navigate these regulatory updates efficiently, email us at admin@morulaa.com or visit our website for the latest updates.