Written and maintained by CASRAI Editorial Board
Last updated
Not medical or regulatory advice. This page gives general product and quality-system information for lab, clinic and procurement staff.
Short answer
“GMP certified” is not one document. For medical devices in the United States, the good-manufacturing-practice rule is a regulation that manufacturers must follow, 21 CFR Part 820, now titled the Quality Management System Regulation (QMSR). A supplier’s “GMP certified” claim can point to several different things, and each proves something different. Ask which document the claim rests on, who issued it, and which products and sites it covers.
Definition and scope
Good manufacturing practice (GMP) is the family of quality rules that govern how regulated health products are made. Which rule applies depends on the product. Finished drugs fall under 21 CFR Parts 210 and 211. Medical devices fall under 21 CFR Part 820. Our good manufacturing practice guide covers the general concept, and GMP vs cGMP explains the wording difference.
How the US device rule works today
FDA states that the QMSR became effective on February 2, 2026. It amends the device current good manufacturing practice (CGMP) requirements in 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. If an ISO clause conflicts with the Federal Food, Drug, and Cosmetic Act or FDA regulations, the Act and regulations control. FDA also stopped using the Quality System Inspection Technique (QSIT) for device inspections on that date (FDA QMSR page, checked 2026-11-01).
The regulation text itself, 21 CFR 820.10, requires a manufacturer subject to the part to document a quality management system that complies with the applicable requirements of ISO 13485 and with the other applicable requirements of Part 820 (eCFR, checked 2026-11-01). The text does not describe a stand-alone GMP certificate. For the standard and its certification route, see ISO 13485 certification; for the regulation, see 21 CFR Part 820.
What a “GMP certified” claim can mean: a claim-to-document checklist
The table separates claims you may see on a supplier page or quote from what the regulations establish. The third column is our editorial suggestion for what to request, not a regulatory requirement.
| Supplier says | What the regulations establish | Reasonable document to ask for |
|---|---|---|
| “FDA registered” | Under 21 CFR 807.39, registration of a device establishment or assignment of a registration number does not denote approval of the establishment or its products, and implying official approval from registration is misbranding. | The registration details, plus a separate statement of what quality system the supplier operates. |
| “Compliant with 21 CFR 820 / QMSR” | Under 21 CFR 820.10, a manufacturer subject to the part must document a quality management system that complies with applicable ISO 13485 requirements and the other applicable Part 820 requirements. | The supplier’s statement of which products and sites fall under the part, and the quality manual or its summary. |
| “ISO 13485” | QMSR incorporates ISO 13485:2016 by reference. Section 820.10 does not mention third-party certificates. | If a certificate is offered, its issuing body, scope, site address and validity dates; see our ISO 13485 certification guide. |
| “cGMP” for a drug product | 21 CFR Parts 210 and 211 govern current good manufacturing practice for finished drugs (eCFR, checked 2026-11-01). | The regulator’s inspection or compliance record for that site, as the supplier’s market authority issues it. |
Where it matters for labs, clinics and supply decisions
Because the claim is ambiguous, the useful move is to turn it into a documented, product-specific question. These steps are an editorial vetting aid built on the table above:
- Name the product and site the claim covers. A quality system document covers a defined scope, not a company’s whole catalogue.
- Match the claim to the product type. Device claims point to Part 820 and ISO 13485; drug claims point to Parts 210 and 211.
- Record the document, issuer and date next to the supplier file, and re-request it when it expires or the scope changes.
- Put responsibilities for change notices, complaints and records in writing. Our quality agreement guide covers that, and supplier audit and supplier risk assessment cover verifying what the supplier says.
If the supplier is a contract manufacturer rather than the brand owner, see contract manufacturing for medical devices and ask which party holds the quality system.
Common misunderstandings
“Registered with FDA” means “approved”
It does not. 21 CFR 807.39 says registration does not denote approval, and treating it as approval is misleading.
“The old QSR rule is what applies”
FDA states that Part 820 is now titled the QMSR and has been effective since February 2, 2026, with ISO 13485:2016 incorporated by reference. Supplier material that still describes the pre-2026 structure may be out of date.
“A GMP certificate from one country covers every market”
The US regulations cited on this page apply to the US market only. Ask for the document that matches the market where the product will be used.
FAQ
What does “GMP certified” mean for a medical supply?
There is no single meaning. In the US it usually refers back to a manufacturer meeting the device quality regulation (Part 820 / QMSR) or the drug rules (Parts 210 and 211), possibly alongside an ISO 13485 certificate. Ask which document backs the statement.
What should I look for in a GMP certified medical device manufacturer?
Ask for the scope of its quality system (products and sites), the standard it follows, and any certificate with issuer and dates. FDA registration alone does not show approval (21 CFR 807.39).
Is there a quality agreement template for a medical device supplier?
Our quality agreement guide explains what such an agreement is for. Have your quality and legal staff adapt any template to your products and obligations.
Sources
- FDA, Quality Management System Regulation (QMSR), checked 2026-11-01.
- 21 CFR 820.10, Requirements for a quality management system, checked 2026-11-01.
- 21 CFR 807.39, Misbranding by reference to establishment registration or to registration number, checked 2026-11-01.
- 21 CFR Part 210, Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs, checked 2026-11-01.
