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Medical component supplier rules by country
A machining supplier is regulated through its customer, and the customer's country decides which quality rule, which audits and which documents apply. This index compares the buyer countries that matter most for machined medical parts, as of October 2026.
The buyer countries compared
| Country | Regulator | Quality system rule for the device maker | Supplier audit practice | Drawing habits |
|---|---|---|---|---|
| United States | FDA | 21 CFR 820 QMSR, built on ISO 13485:2016, since 2 February 2026 | Device maker audits; FDA can read supplier audit reports | ASME Y14.5, third angle, inch or metric |
| Germany | BfArM, Länder authorities; notified bodies designated by ZLG | EU MDR, EN ISO 13485 | Device maker audits; notified body unannounced audits can reach critical suppliers | ISO GPS, first angle, metric |
| Switzerland | Swissmedic | Medical Devices Ordinance (MedDO), aligned with the EU MDR | Similar to the EU; EU recognition status to check | ISO GPS, first angle, metric |
| Ireland | HPRA | EU MDR, EN ISO 13485 | Often run under the quality system of a US or global parent | Mixed: ASME at US-owned plants, ISO elsewhere |
| United Kingdom | MHRA | UK Medical Devices Regulations 2002 as amended; CE recognition rules to check | Similar to the EU in practice | ISO or ASME, by company |
| Japan | MHLW and PMDA | PMD Act; MHLW Ordinance No. 169 QMS, aligned with ISO 13485 | Device maker audits; detailed document review | JIS, first angle, metric |
| South Korea | MFDS | Medical Devices Act; KGMP, aligned with ISO 13485 | Device maker audits; strong dental implant sector | KS and ISO, metric |
Summary only, as of October 2026. Rules and recognition arrangements change. Check each regulator's own pages before relying on a row.
What is the same everywhere
The regulator oversees the device maker. The device maker controls the shop. In every country on this list, that control rests on the same ideas, because every quality rule here is built on or aligned with ISO 13485:
- Supplier evaluation proportionate to the risk of the part.
- A written agreement that the supplier notifies changes before making them.
- Traceability from material heat to shipped part, full traceability for implants.
- Validation of processes whose output cannot be fully verified.
- Records kept for the device lifetime the device maker defines.
The standards index covers these requirements one standard at a time.
What changes by country
Country pages cover what a supplier meets in practice: where the buyers sit, which documents they send, the language of the quality agreement, the drawing conventions, the material designations, the import checks and the audit habits. They describe the destination market only. Duties, tariffs and recognition dates change often, so every page names its sources and the date it was last reviewed.
The guides cover cross-market topics such as the quality agreement and the first customer audit.
Information, not regulatory or customs advice. Confirm with the regulator, your regulatory team and your customs broker.
Sources
- FDA, Quality Management System Regulation (QMSR)
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), medical devices
- Swissmedic, medical devices
- Health Products Regulatory Authority (HPRA), Ireland
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Ministry of Food and Drug Safety (MFDS), Korea
Standards and regulations change. Check the current text at the source before you rely on it in a submission.
Last reviewed 18 October 2026
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