Medical device quality, design transfer, and supplier control for companies manufacturing in Asia
Exemption from premarket notification is not exemption from the quality system. The two decisions are made under different parts of the regulation, and confusing them is the most common reason a Class II device company arrives at an audit without a defensible design file.
The factory drew it, tooled it, and knows why every dimension is what it is. Your name is on the label. Regulators will ask you for the design file, and "the supplier has it" is not an answer that survives an inspection.
A complete index of approved procedures feels like readiness. It is not. An auditor will pick one procedure and ask to see the records it produced last quarter, and that is where most quality systems come apart.
Transfers go wrong in a specific, predictable way: the product ships from the new factory before the evidence that qualifies the new factory exists. Then someone is asked to sign a document with a date that has already passed.
A heating pad folded in half is a smaller radiating surface carrying the same power. That is a foreseeable use condition, and the chain from foreseeable use to a production test is exactly what a design file is supposed to contain.
Most companies still hold a checklist organized around the old Part 820 subparts. The underlying obligations largely survived the transition, but the vocabulary and structure did not, and a stale index makes real gaps invisible.
Annual on-site audits are not just a best practice for medical device manufacturers relying on China-based suppliers. Remote monitoring alone does not demonstrate the supply-chain control that ISO 13485 and FDA requirements expect.
Ensuring ISO 13485 compliance at a Chinese supplier requires more than reviewing certificates. It demands on-site verification that the factory follows the systems documented in its own quality manual.
Pharmaceutical and biotechnology companies sourcing components and packaging from China face GMP obligations that are non-negotiable, and on-site audits remain the primary tool for verifying them.
We help U.S. medical device companies control outsourced development and manufacturing in Asia.