How to get your products certified for international markets

Certification requirements are the biggest practical barrier for Indian SMEs entering international markets. CE marking for Europe, FDA approval for the US, BIS for specific categories — the requirements vary by product and market, and getting this wrong means your shipment gets stopped at the border.

Start with the destination market and product category. Certification requirements are market-specific and product-specific. A machine exported to Germany needs CE marking; the same machine exported to the UAE may not. An herbal supplement exported to the US needs FDA registration; to the EU it needs different documentation. Don't assume — verify.

CE marking (European Conformity) is required for a wide range of products sold in the EU: machinery, electrical equipment, personal protective equipment, medical devices, and many others. CE marking means the product meets EU safety, health, and environmental standards. Getting CE marked requires: identifying the applicable EU Directives and standards, testing at an accredited laboratory (for most products), compiling a Technical File (documentation of how the product meets the standards), and issuing a Declaration of Conformity. For some product categories, a Notified Body (third-party certification body) must be involved.

FDA registration (US market) for food, medical devices, cosmetics, and drugs requires registration of your facility with the FDA, compliance with US manufacturing standards (GMP), and in some cases, pre-market approval or notification. The requirements vary significantly by product category — get specific guidance for your product.

BIS (Bureau of Indian Standards) certification is mandatory for certain products exported from India. Separately, if your product will be sold under another country's standards body, you may need both.

Use an export consultant or certification body who specialises in your product category and target market. The cost of wrong advice is far higher than the cost of a specialist. FIEO and EPC can provide referrals to accredited certification bodies.

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