Safety of Household, Commercial and Similar Electrical Appliances
Oral Hygiene Appliances
Strategic Recommendations for Oral Hygiene Appliances Manufacturers & importers
- Start BIS Certification Process Now
Early application ensures testing and certification completion before deadlines. - Partner with Compliance Experts
ERA’s team can guide you through BIS licensing, product testing, and labeling compliance. - Contact ERA Support Team
📧 cs@eraglobal.co.in | 📞 +91 9599296331 | 💬 WhatsApp
Expert assistance for certification, audits, and stock declarations. - Track Notifications & Circulars
Subscribe to the ERA Newsletter for updates on BIS circulars, QCO amendments, and enforcement alerts. - Ensure Marking Before Sale
All oral hygiene appliances must carry the ISI mark before being sold in the Indian market.
| Section | Details |
|---|---|
| Product Name | Oral Hygiene Appliances |
| Applicable Indian Standard (IS) No. | IS 302 (Part 1):2024 |
| Title of Indian Standard | Household and Similar Electrical Appliances – Safety – Part 1: General Requirements |
| Quality Control Order | Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2025 |
| Notification & Amendments | Notified via S.O. 2232(E), dated 19 May 2025 Supersedes QCO 2024: S.O. 4098(E), dated 17 Sept 2024 |
| Final Enforcement Date | Large & Medium Enterprises: 19 March 2026 Small Enterprises: 19 June 2026 Micro Enterprises: 19 September 2026 |
| Objective & Scope | To ensure electrical safety, hygienic operation, and product reliability of oral hygiene appliances through BIS certification. |
| Products Covered | Electrically powered oral care appliances such as electric toothbrushes, oral irrigators, and similar dental cleaning devices (≤250V AC / ≤480V DC). |
| Exemptions | - Export-only products - R&D imports up to 200 units/year - Schedule A stock clearance up to 6 months post enforcement |
| Industries Impacted | Personal Care Appliance Manufacturers, Oral Care Brands, Healthcare Retailers, E-commerce Platforms |
| Mandatory Compliance | - Must comply with IS 302 (Part 1):2024 - BIS certification under Scheme-I is mandatory - ISI mark must appear on product and packaging |
| Next Steps for Stakeholders | Apply for BIS license, complete testing, affix ISI mark, and declare Schedule A stock |
| Legal Framework Provision & Enforcement | Enforced by BIS under the BIS Act, 2016 with inspection and prosecution authority |
| Penalties | Non-compliance may result in seizure of stock, license suspension, fines, or imprisonment up to 2 years, or both |
| Conclusion | From 19 March 2026, all oral hygiene appliances must be BIS-certified and ISI-marked under IS 302 (Part 1):2024 for sale in India. |
| References/Annexures | - QCO 2025: S.O. 2232(E) [19 May 2025] - Superseded QCO 2024: S.O. 4098(E) [17 Sept 2024] |
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Notification
Oral Hygiene Appliances are included under the Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2025, notified via S.O. 2232(E) on 19 May 2025 under the BIS Act, 2016. This replaces the earlier QCO issued on 17 September 2024.
Overview
These appliances include electric toothbrushes, oral irrigators, and other devices designed for personal oral care. As they are used in contact with the mouth and gums, the regulation ensures they meet high safety and hygiene standards to protect users from electrical hazards and contamination.
Objective & Scope
To mandate compliance with IS 302 (Part 1):2024 for electrical safety, waterproofing, durability, and hygienic design, ensuring safe and effective oral care.
Products Covered
- Electric toothbrushes
- Oral irrigators (water flossers)
- Electric interdental cleaners
- Operating at ≤250V AC or ≤480V DC
Exemptions Provided
- Products meant solely for export
- R&D imports up to 200 units/year
- Schedule A inventory clearance up to 6 months after enforcement
Industries Impacted
- Oral care appliance manufacturers
- FMCG & personal hygiene brands
- Dental clinics and retail pharmacy chains
- Online marketplaces
Mandatory Compliance Requirements
- BIS certification under Scheme-I
- Conformity to IS 302 (Part 1):2024
- ISI marking on product and retail packaging
Enforcement Timeline
- Large & Medium Enterprises: 19 March 2026
- Small Enterprises: 19 June 2026
- Micro Enterprises: 19 September 2026
Next Steps for Stakeholders
- File BIS license application
- Conduct product testing in BIS-approved labs
- Integrate ISI marking in manufacturing
- Declare Schedule A stock for clearance
Legal Provisions, Enforcement & Penalties
The BIS will enforce the regulation under the BIS Act, 2016.
Penalties for non-compliance include:
- Seizure of unmarked/non-compliant stock
- Suspension or cancellation of the license
- Fines and/or imprisonment up to 2 years, or both
Conclusion
From 19 March 2026, all oral hygiene appliances sold, imported, or manufactured in India must comply with IS 302 (Part 1):2024, be BIS-certified, and bear the ISI mark. Early action will ensure uninterrupted sales and avoid penalties.
Ready to start your certification journey?
Let us help you navigate regulatory challenges and achieve certification with ease. Leave us your details, and we’ll get back to you—or request a free consultation today.