Product Export Compliance
Technical trade barriers — CE Marking, RoHS, REACH, BIFMA, ISO 13485 — can block your products from foreign markets. We help Indian manufacturers understand, document, and demonstrate compliance.
What is Product Export Compliance?
Exporting products to the European Union, United Kingdom, United States, or other regulated markets requires demonstrating that your product meets the applicable safety, environmental, and performance requirements of that jurisdiction. These requirements are defined in Directives, Regulations, and national standards — not in a single global standard. Identifying the right requirements for your product type and market is the first and often most confusing step.
Common Compliance Frameworks We Support
- CE Marking — EU Low Voltage Directive, Machinery Directive, Medical Device Regulation (MDR), PPE Regulation.
- RoHS Directive — Restriction of hazardous substances in electrical and electronic equipment.
- REACH Regulation — Chemical substance registration and restriction for EU supply chains.
- BIFMA Standards — Furniture safety and sustainability for North American markets.
- ISO 13485 — Medical device quality management for regulatory approval in EU, Canada, Japan.
- BIS Certification — Indian Standards certification for domestic and export products.
- IATF 16949 / PPAP — Automotive product and process approval requirements.
How Fusion Helps
Requirement Identification: We determine exactly which Directives, Regulations, and standards apply to your product in your target market.
Technical File Compilation: We help assemble the required technical documentation — design specifications, test reports, risk assessments, and conformity evidence.
Testing Coordination: We advise on which laboratory tests are needed and liaise with accredited test laboratories on your behalf.
Declaration of Conformity: We guide you through drafting the final compliance declarations and CE / regulatory marking requirements.
Importer & Authorized Representative: We advise on the requirements for in-country importer or authorized representative appointments.
Fusion Certification is an independent consultancy. Regulatory compliance decisions and technical approvals are the responsibility of the appropriate national authority or conformity assessment body.
