Certification marks and regulatory approvals that let your products reach Indian and international markets — from BIS to CE Marking.
Mandatory certification for select products manufactured abroad and sold in India.
Ask a consultant → ISICertification mark for industrial products under BIS, indicating conformity to Indian quality standards.
Ask a consultant → CEDeclares conformity with EU health, safety and environmental protection standards for sale in the EEA.
View details → CDSCOMedical device registration and compliance for manufacturing or importing devices in India.
View details → WPCApproval required for wireless communication products/equipment sold or used in India.
Ask a consultant → BIFMASustainability and performance certification for furniture products, widely recognised in North America.
Ask a consultant → AYUSHCertification mark for Ayurvedic, Yoga, Unani, Siddha and Homoeopathy products.
Ask a consultant → AGMARKQuality certification mark for agricultural products in India, ensuring conformity to grading standards.
Ask a consultant → HALALCertifies that products and processes adhere to Islamic law, essential for food, cosmetics and pharma exports.
Ask a consultant →CE Marking is a conformity marking indicating that a product complies with the applicable European Union (EU) requirements that apply to that product. Where CE marking is required, the manufacturer or authorised representative is responsible for ensuring conformity with all applicable EU legislation before placing the product on the EU market.
CE marking may be required for products covered by specific EU directives or regulations relating to health, safety, environmental protection and product performance. Not every product requires CE marking. The applicable legislation depends on the product category, intended use, design and technical characteristics.
“CE” refers to Conformité Européenne.
Depending on the product, applicable CE legislation may include:
The applicable EU legislation and conformity assessment procedure must be determined according to the specific product.
RoHS (Restriction of Hazardous Substances) is an EU regulatory requirement restricting specified hazardous substances in electrical and electronic equipment within its scope.
The principal legislation is RoHS Directive 2011/65/EU, supplemented by Commission Delegated Directive (EU) 2015/863.
The current RoHS restrictions cover:
RoHS compliance includes determining product applicability, assessing materials and components, maintaining supplier evidence, conducting testing where required, and maintaining appropriate technical documentation.
CE Marking and RoHS are separate but related compliance requirements. Where applicable, RoHS compliance can form part of the conformity requirements for electrical and electronic products subject to CE marking legislation.
The Medical Devices Regulation (EU) 2017/745 (MDR) establishes the European regulatory framework for medical devices and replaced the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).
The MDR became generally applicable on 26 May 2021 and strengthens requirements for medical device safety and performance, risk management, clinical evaluation, technical documentation, conformity assessment, post-market surveillance and traceability.
Depending on the device classification and conformity assessment route, involvement of an EU Notified Body may be required.
CDSCO (Central Drugs Standard Control Organisation) is India's national regulatory authority for drugs and medical devices under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
Medical devices placed on the Indian market are regulated under the Medical Devices Rules, 2017 (MDR 2017), along with applicable provisions of the Drugs and Cosmetics Act, 1940 and related regulatory requirements.
Medical devices are classified according to their associated risk, and the applicable regulatory pathway depends on the device classification, intended use, manufacturer/importer status and applicable Indian requirements.
OMCS provides CDSCO medical device regulatory consultancy and compliance support to manufacturers, importers and organisations seeking to place applicable medical devices on the Indian market.
Our support may include device classification, regulatory pathway assessment, documentation support, licensing and registration guidance, QMS support, labelling review, technical documentation and regulatory compliance preparation based on the applicable product and regulatory requirements.
Note: CDSCO requirements vary according to the type and classification of medical device and the applicant's role in the supply chain. Regulatory requirements should therefore be assessed on a product-specific basis.
We’ll help you map which product marks and regulatory approvals actually apply to your product.