News & Insights

OEM (Original Equipment Manufacturing) means the factory produces to your design and specifications under your brand — you own the product definition. ODM (Original Design Manufacturing) means you brand the factory's existing, proven design, usually with options to customize colors, packaging and manuals. ODM is faster and cheaper to launch; OEM gives you full product control.

CE marking is mandatory for selling medical devices in the EU/EEA — under EU MDR 2017/745 for general medical devices, or EU IVDR 2017/746 for in vitro diagnostic (IVD) devices. The US market requires FDA establishment registration and device listing instead, and most Class II devices additionally need 510(k) clearance. Many other markets (Middle East, Southeast Asia, Latin America) accept CE or FDA documentation as the basis for their own registration.

Establishment registration means the manufacturing facility is registered with the FDA and is renewed annually — it is not a product approval. 510(k) clearance is a product-level review where the device demonstrates substantial equivalence to a legally marketed device. A "FDA-registered facility" claim alone does not mean any specific product is FDA-cleared — always ask for the 510(k) number of the exact product.

Three steps: first, take the certificate number and verify it directly on the issuing certification body's website — never rely on a PDF alone. Second, check that the certificate scope actually covers your product category, not just an unrelated activity. Third, confirm the certification body is accredited by an IAF member (such as UKAS, DAkkS or ANAB) and that the certificate is within its validity period.

A Free Sale Certificate (FSC, also called Certificate of Free Sale) is an official document issued by the health authority of the exporting country, confirming that the product is legally sold on its home market. It is commonly required when registering medical products in the Middle East, Latin America and parts of Asia — your supplier can usually support the application for OEM orders.

Under EU MDR 2017/745 (and EU IVDR 2017/746 for IVDs), CE certificates issued by notified bodies are valid for a maximum of five years. Note that MDR Class I devices are self-declared and have no notified-body certificate at all. Maintaining validity requires passing annual surveillance audits and keeping the technical documentation continuously updated. When sourcing, always check both the certificate's expiry date and the manufacturer's most recent surveillance audit status.