Product & Export Compliance
Every export market has its own technical requirements. CE Marking for Europe, FCC authorisation for the US, FDA pathways for medical and food products — we help Indian manufacturers navigate each framework correctly.
Compliance Frameworks We Support
Product compliance requirements are highly specific to product type, target market, and end use. Identifying the right framework is the first, and often most complex, step.
CE Marking
Mandatory conformity mark for products sold in the European Economic Area — applicable EU Directives (Low Voltage, Machinery, PPE, MD, IVDR) and Declaration of Conformity.
Learn moreRoHS Compliance
Restriction of Hazardous Substances in electrical and electronic equipment — substance threshold analysis, material declarations, and technical file preparation.
Learn moreREACH Compliance
EU chemical substance regulation — SVHC screening, Annex XVII restriction checks, and supply chain documentation for Indian product exporters.
Learn moreBIFMA — Furniture Standards
ANSI/BIFMA X5 safety standards and BIFMA LEVEL 1/2/3 sustainability certification for commercial furniture exported to North American markets.
Learn moreISO 13485 — Medical Devices
Quality management system for medical device manufacturers, required for EU MDR, Health Canada, TGA Australia, and CDSCO India compliance.
Learn moreIATF 16949 — Automotive
Automotive sector QMS with core tools (APQP, PPAP, FMEA, MSA, SPC) and OEM customer-specific requirements.
Learn moreUS Market Compliance
The United States has distinct regulatory frameworks from the EU. FCC and FDA are the primary agencies for electronics and health-regulated products respectively. Neither is an ISO standard — both involve regulatory submission and authorisation processes that differ fundamentally from European conformity assessment.
FCC Compliance — US Market Access
Electronic devices intended for the US market may require FCC (Federal Communications Commission) authorisation under CFR Part 15 (unintentional radiators, intentional radiators) or Part 18 (industrial, scientific, and medical equipment). The FCC authorisation process — which may involve Supplier's Declaration of Conformity (SDoC), Certification by a Telecommunications Certification Body (TCB), or notification — is determined by the product category and frequency characteristics. FCC authorisation is granted by the FCC or an approved TCB, not by Fusion Certification. Fusion supports pre-compliance testing coordination, technical documentation compilation, and selection of appropriate US accredited test laboratories, ensuring your product file is complete before submission.
US FDA Regulatory Support — Medical Devices & Food
Products regulated by the US Food and Drug Administration (FDA) — including medical devices, food, dietary supplements, cosmetics, and OTC drugs — have specific regulatory pathways depending on product category and risk classification. For medical devices: Class I (510(k) exempt or 510(k) notification), Class II (510(k) premarket notification), Class III (PMA — Premarket Approval). For food and cosmetics: FDA Facility Registration and Prior Notice. FDA clearance and approval decisions are made by the FDA; timelines and requirements depend on product classification. Fusion Certification assists with: 510(k) technical file preparation and quality system readiness (21 CFR Part 820 / ISO 13485), FDA Facility Registration advisory, substantial equivalence analysis for medical devices, and food facility registration documentation.
What We Do
- Identify which Directives, Regulations, or standards apply to your specific product in your target market.
- Compile the technical documentation required by regulators and notified bodies.
- Coordinate with accredited test laboratories for required product testing.
- Prepare Declarations of Conformity and DoC labelling requirements.
- Advise on FCC authorisation routes (SDoC vs TCB Certification) for electronic devices.
- Support FDA 510(k) technical file preparation and quality system readiness.
- Advise on authorised representative requirements for EU/UK regulated products.
Fusion Certification is an independent consultancy. CE Marking, FCC authorisation, and FDA clearance/approval are issued by the applicable regulatory authority or designated conformity assessment body — not by Fusion. Fusion provides technical file preparation, testing coordination, and system-readiness support only.