Recent Updates in India’s Medical Device Regulation in India and IVD Regulatory Landscape — CDSCO Latest Circulars & Compliance Advisory

India’s regulatory framework for medical devices and in-vitro diagnostics (IVDs) has seen several important developments in late 2024 and early 2025. Key updates include an expansion of the list of notified medical devices (bringing items like surgical gloves, bandages, and syringes under regulation), revisions to risk-based device classification (with draft lists open for stakeholder feedback), and the introduction of a draft adverse event reporting form specifically for IVD devices. Each of these updates is summarized below in a regulatory brief for medical professionals and compliance stakeholders. Businesses are encouraged to consult a qualified medical law firm India or seek pharmaceutical company legal advisory India to stay ahead of these evolving requirements.

Inclusion of Gloves, Bandages, and Syringes as Notified Medical Devices (Dec 2024) — Update Under Medical Device Regulation in India

On 10 December 2024, the Ministry of Health & Family Welfare issued Gazette Notification S.O. 5330(E) to amend a prior notification (S.O. 2237(E) dated 1 June 2018) and broaden the scope of regulated medical devices. Notably, this amendment explicitly brings various types of gloves and other common medical supplies under the definition of medical devices for regulatory purposes. The following additions were made in the notification’s schedule:

• Surgical Gloves and Medical Examination Gloves – added under serial no. 2 (after the word “Condoms”)
• Surgical Gloves and Medical Examination Gloves – added under serial no. 3 (after the word “Disinfectant”).
• Surgical Gloves, Medical Examination Gloves, Cotton Bandages, Anticoagulant Solutions (used in blood bags), and Disposable Syringes – added under serial no. 5 (after “Falope Rings”).

By this amendment, these items (various gloves, bandages, anticoagulant solutions, and syringes) are formally notified as medical devices, thereby subjecting them to the Medical Devices Rules, 2017. This change expands regulatory oversight to cover a broader range of commonly used medical supplies, aligning with public health needs and safety standards. (The principal notification S.O. 2237(E) of 2018, last amended on 25 April 2023, was thus updated accordingly.) A medical law firm India or legal service India provider can assist manufacturers in obtaining the necessary licences for these newly notified devices.

CDSCO Latest Circulars: Draft Risk-Based Classification Updates – Stakeholder Feedback Invited (Jan 2025)

On 6 January 2025, the Central Drugs Standard Control Organisation (CDSCO) issued a notice (File No. MED-16014(12)/1/2024-eOffice, dated 06-01-2025) announcing draft updates to the risk-based classification of medical devices and inviting stakeholder comments. The existing classification lists for four categories of devices were revisited and expanded based on their risk class (as per the First Schedule of the Medical Devices Rules 2017) and international classification practices. The four affected categories and the number of devices identified in each are:

• Interventional Radiology Devices – 186 devices
• Radiotherapy Devices – 114 devices
• Oncology Devices – 75 devices
• Class A (Non-sterile, Non-measuring) Medical Devices – 803 devices

These draft lists (with newly added entries in each category) were circulated as an annex for finalization. Public feedback was explicitly sought: CDSCO urged all concerned stakeholders — including medical device manufacturers, industry associations, and healthcare professionals — to review the proposed classifications and submit comments or objections. The notice provided an online Google Form link for submitting feedback, with a deadline of 30 days from the draft’s publication (i.e. by early February 2025). Stakeholder input will be considered before finalizing the revised classification lists, underscoring the collaborative approach to regulatory updates. This initiative aims to ensure India’s device classification remains up-to-date and in harmony with globally recognized risk categories, facilitating appropriate regulatory controls for each class of device. For guidance on responding to such CDSCO latest circulars, companies may consult the best tech law firms in Delhi or engage a tech law partner experienced in medical device regulation in India.

Draft IVD Adverse Event Reporting Form Released for Comment (Feb 2025) — Pharmaceutical Company Legal Advisory India

In a move to strengthen post-market surveillance, the Materiovigilance Programme of India (MvPI) – under the Indian Pharmacopoeia Commission – released a draft Adverse Event Reporting Form for In-Vitro Diagnostic Medical Devices (IVD-MDs) on 17 February 2025. The draft form was developed by MvPI in collaboration with the Central Drugs Standard Control Organization (CDSCO) and IVD manufacturers’ associations, incorporating prior stakeholder suggestions. Its primary purpose is to establish a standardized system for capturing and analyzing adverse events related to IVD kits and devices, thereby enhancing patient safety and improving product quality.

Target Users

The reporting form is intended for use by all entities and professionals involved with IVD devices, including:

• Domestic manufacturers, importers, and distributors of IVD medical devices
• Pathology laboratories and blood donation centres
• Government programme in-charges (public health programs using IVD kits)
• Healthcare professionals with direct or indirect knowledge of IVD device use and incidents

Notably, the draft emphasizes that the reporter’s identity will be kept confidential and that submitting a report has no legal liability or punitive implications for the reporter. This is to encourage open reporting of incidents without fear of blame, focusing on safety improvements.

Major Data Fields of the Draft Form

The IVD adverse event report form is structured to collect comprehensive information about the incident. Key data sections include:

• Reporter Information: Name, affiliation/organization (e.g. manufacturer, hospital, lab), contact details, and signature or authorization. (The form assures reporter confidentiality.)
  • Device Details: Identification of the IVD device involved – product name and type (e.g. glucose kit, pregnancy test kit), manufacturer, model/catalogue number, batch/lot number, expiry date, and any relevant license or registration details.
• Event Description: A detailed narrative of the adverse event or problem observed. This includes the nature of the issue (e.g. false positive/negative result, device malfunction, user error, etc.), how and when it was detected, and any consequences. The date of the event and detection, and the setting in which it occurred (laboratory, point-of-care, etc.) are documented.
• Patient Information: If a patient or test subject was affected, the form captures relevant details (such as patient age/sex or identifier, and any impact on patient health or treatment due to the IVD error). For events with no direct patient impact (e.g. quality control failures), this section may be not applicable.
• Assessment and Outcome: Fields for the reporter’s preliminary assessment of the event – e.g. severity of the event (serious or non-serious), outcome (any harm caused, need for medical intervention, incorrect treatment decisions, etc.), and any immediate actions taken. This section may also include categorization of the event (such as product defect, user-related issue, environmental cause) and whether the device was used according to instructions.

The feedback window for this draft IVD-MD reporting form was open until 5 March 2025. Stakeholders (manufacturers, regulators, healthcare providers, etc.) were invited to review the form and submit comments or suggested improvements by email or via the designated portal. The draft explicitly noted that its content is not final and will be revised based on the feedback received before being finalized by MvPI. This collaborative approach – involving regulatory authorities and industry associations – aims to produce a user-friendly yet thorough reporting tool. Once finalized, the IVD adverse event form will integrate into the Materiovigilance Program, complementing the general Medical Device Adverse Event (MDAE) reporting form (which was updated in late 2024). Together, these efforts reflect the Indian regulator’s push for a robust post-market surveillance system, where timely reporting of device-related adverse events leads to rapid identification of risks and preventive actions. Companies seeking to navigate these obligations may benefit from engaging the top tech law firms in Delhi or a dedicated medical law firm India for pharmaceutical company legal advisory India.

Conclusion

These recent regulatory updates signal India’s continued commitment to strengthening medical device oversight. By expanding the list of regulated devices to include everyday medical supplies, refining risk-based classifications in line with global standards, and improving adverse event reporting mechanisms for IVDs, regulators are working to enhance patient safety and device quality. Medical device companies, importers, healthcare institutions, and laboratory professionals should take note of these changes and participate in the consultative processes. Compliance with the new requirements – from licensing of newly notified devices (like gloves and syringes) to adherence to classification and vigilance reporting – will be crucial. Regulatory bodies and stakeholders are expected to collaborate closely through feedback and adherence, ensuring a smoother implementation of these updates in India’s medical device and diagnostics sector.

For end-to-end support on medical device regulation in India, tracking CDSCO latest circulars, or obtaining pharmaceutical company legal advisory India, businesses are advised to partner with a trusted legal service India provider, an experienced medical law firm India, or one of the best tech law firms in Delhi offering dedicated regulatory counsel.

Sources: Recent government notifications and public notices, as cited above, including Gazette Notification S.O. 5330(E), CDSCO/DCGI notices and industry summaries, and announcements from the Materiovigilance Programme of India. These provide the factual basis for the updates summarized in this report. All medical device stakeholders are advised to consult the official documents for full details and to ensure compliance with the latest regulations.

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