Medical device passive components for the United States are sourced under a finished-device maker’s supplier controls, not a component rule. The FDA’s QMSR took effect on 2 February 2026. We searched the 451 pages of Walsin datasheets we hold for 12 medical terms and found 0 hits, so any medical use is your qualification, not a Walsin statement.
Venatech Limited, an authorised Walsin distributor in Hong Kong, wrote this for a design engineer or buyer in the United States who builds medical device electronics and wants to know which documents a Hong Kong source can supply for Walsin Technology (Walsin) passives. It uses the 28 Walsin datasheets we hold, the parametric exports and our stock list as at 23 September 2026. Every part number is real. Each FDA statement is cited to a page fetched on 20 October 2026. We give no regulatory advice: your quality and regulatory team decides what your file needs.
What does the FDA QMSR say about suppliers and components?
It puts supplier oversight on the finished-device maker, and it asks for a record of how much control was applied. The FDA says the Quality Management System Regulation became effective on 2 February 2026 and incorporates ISO 13485:2016, and the final rule text asks for an ongoing, risk-informed assessment of suppliers, including for components. The table sets three points against what we hold.
| FDA point | What the source says | Source | Match / mismatch with our documents |
|---|---|---|---|
| Effective date and standard | Effective 2 February 2026; incorporates ISO 13485:2016 | FDA QMSR page, current as of 2 February 2026 | Mismatch: we hold no ISO 13485 certificate, and the standard is named on 0 of our 451 datasheet pages |
| Supplier assessment | Ongoing, risk-informed; manufacturers document the type and extent of controls; where audits are impractical, history, monitoring and inspection can be used | Final rule, 89 FR 7496, 2 February 2024 (Comment 33 response) | Match in part: we can supply datasheets, lot and date-code traceability and, on request, a certificate of conformity per shipment |
| Supplier audit records | The FDA can review supplier audit reports under the new rule | FDA QMSR frequently asked questions | Mismatch: we hold no audit report on Walsin to give you |
The same final rule says a certificate alone may not give adequate supplier assurance, in the FDA’s words: “certification may not provide adequate assurances of supplier quality without further evaluation”. It also says makers of components or parts of finished devices are not subject to the rule, though the FDA encourages them to consider it and contracts may still require compliance. Both points came from our reading of the Federal Register text.
Does the FDA require a component distributor to hold ISO 13485?
No certificate is required, by the FDA’s own page. The FDA states it does not require ISO 13485 certification, will not issue such certificates, and that a certificate does not exempt a manufacturer from an FDA inspection. Venatech holds no ISO 13485 and no ISO 9001 certificate.
Our view, labelled as ours: the absence of a certificate shifts the work to evidence. A medical file for a passive part is a set of documents that let your team assess the supplier and the part. Ask for the documents, not for a badge. Our earlier post on passives for a medical device covers the circuit side. This one covers the paperwork.
What do 451 Walsin datasheet pages say about medical use?
Nothing. We searched all 28 datasheets we hold, 451 pages, for 12 terms (13485, medical, implant, biocompat, healthcare, sterili, FDA, clinical, patient, life support, pacemaker, MRI) and found 0 hits on every one. We then searched every text column in the 120 non-empty export files, 390,477 rows, for the same stems. We found 0 there too.
We have not seen this counted anywhere. It does not mean a Walsin part is unfit for a medical device, and we say nothing of the kind. It means no document we hold names a medical use, a medical quality system or a biocompatibility position, so the claim cannot come from us. The words counterfeit, conformity and PCN also appear on 0 of the 451 pages. Phrase every absence as not in the documents we hold, and ask Walsin in writing.
Which documents does a medical file get for a Walsin part, and which does it not?
It gets a datasheet for 1,001 of our 1,125 stock lines, and none for 124. Mapping each stock line to a series, we counted 764 MLCC lines in series with a datasheet and 237 WR resistor lines under the WR sheet: 1,001 of 1,125 (89.0%) have one, and 124 do not. The 237 depend on a sheet dated September 2016.
| Walsin part | Line | Datasheet we hold | Held, 23 September 2026 | Match / mismatch for a medical supplier file |
|---|---|---|---|---|
0402B104K500 |
MLCC, general purpose, 0402, 100 nF, 50 V | General Purpose sheet | Yes | Match on a datasheet; no medical statement |
WR06X10R0FTL |
Chip resistor, general purpose, 0603, 10 ohm | WR sheet, September 2016 | Yes | Mismatch on currency: ten years old |
MF12E1R00FTL |
Chip resistor, anti-surge, 1206, 1 ohm | None | Yes | Mismatch: no datasheet |
WLPH252012M2R2PP |
Inductor, 2520, 2.2 microhenry | None; export shows 2.27 A rated current, saturation current blank | Yes | Mismatch: no datasheet and no saturation figure |
WA04X300JTL |
Resistor array | None | Yes | Mismatch: no datasheet |
Specifications for the lines without a datasheet are on Walsin’s own site; we link no value from our export for you to rely on. The Walsin MLCC datasheet index and our post on reading a Walsin part number show where each sheet applies. We state differences, not substitutions. Confirm against both datasheets and qualify in your own circuit.
What can Venatech support for a United States medical device build?
A cross-reference, a dated stock position, a datasheet on request and basic traceability. We cannot support a medical qualification statement, an ISO 13485 certificate, a biocompatibility position or a country of origin, because none is in the documents we hold. None of the 96 column names across Walsin’s 203 export files is an origin field.
We hold no United States office, entity or stock. Our locations are Hong Kong, Shenzhen, Singapore and Jiangmen, with Chengdu in preparation. Check what is held on our ready stock page, then paste your BOM into the free cross-reference tool, which decodes 18 manufacturers’ part numbers across 800,000+ crossable parts, or the BOM tool. The MLCC range lists the families. Ask us for the datasheet that covers your part number and it will come by email.
The short version
The FDA QMSR, effective 2 February 2026, puts supplier control on the device maker and does not require ISO 13485 certification. Of the 451 Walsin datasheet pages we hold, 0 name medical use, and 124 of our 1,125 stock lines have no datasheet. A medical file for these parts is built from evidence you gather.
Send us the passive lines of your device BOM and we will return the Walsin parts, the datasheet status of each and the differences, with qualification staying with you. Which document does your supplier approval ask for that we have not listed?
Sources
Fetched 20 October 2026. The FDA statements come from these pages; the counts come from our own Walsin datasheets, exports and stock list.
- FDA, Quality Management System Regulation (QMSR) (content current as of 2 February 2026): https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr
- FDA, Quality Management System Regulation frequently asked questions: https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions
- Federal Register, Medical Devices; Quality System Regulation Amendments, Vol. 89, No. 23, 2 February 2024 (89 FR 7496): https://www.fda.gov/media/177022/download
Frequently asked questions
What does the FDA QMSR say about suppliers and components?
It took effect on 2 February 2026 and incorporates ISO 13485:2016. The final rule asks the device maker for an ongoing, risk-informed assessment of suppliers, including for components, and a record of the controls applied. The duty sits with the finished-device maker.
Does the FDA require a component distributor to hold ISO 13485?
No. The FDA states it does not require ISO 13485 certification and does not issue such certificates. Venatech holds no ISO 13485 and no ISO 9001 certificate. Ask for evidence about the supplier and the part instead.
What do Walsin datasheets say about medical use?
Nothing in the 451 pages we hold. We searched 12 medical terms and found 0 hits, and 0 in the text columns of 390,477 export rows. That is not a statement about fitness. It means the medical claim cannot come from us.
Does every stocked part have a datasheet?
No. By our series mapping, 1,001 of 1,125 stock lines (89.0%) have one and 124 do not. The 237 WR resistor lines depend on a datasheet dated September 2016. Inductor, thin film, disc, RF and antenna lines have none.
Can you supply a certificate of conformity?
On request, one per shipment, together with lot and date-code traceability and original sealed Walsin packaging. It is not a medical qualification statement. Ask what Walsin has issued in writing before you promise anything to your own customer.
Can you state the country of origin of a Walsin part?
No. None of the 96 column names in 203 Walsin export files is an origin field, and no datasheet names a plant or country. Confirm with your compliance team and ask Walsin in writing.