A United Kingdom medical device maker who must explain every component change after launch needs a second part named before the change is forced. Of 764 stocked Walsin MLCC lines we matched to the export, 234 have no sibling part at all, and 528 of the 530 that do have it only in a different series.
Venatech Limited, an authorised Walsin distributor in Hong Kong, holds the Walsin Technology (Walsin) MLCC parametric export: 24,026 rows, 23,601 distinct part numbers. This post is for a purchasing or design engineer at a United Kingdom medtech manufacturer who has a bill of materials, a regulator that wants post-market evidence, and a ceramic capacitor line that must not become a surprise. Every part number below is real, every count is ours, and the regulatory statements name their source and the day we fetched it (23 October 2026).
What changed for UK medical device makers on 16 June 2025?
Post-market duties tightened. The Medicines and Healthcare products Regulatory Agency (MHRA) announced on 16 June 2025 that new post-market surveillance rules took effect in Great Britain: serious incidents must be reported within 15 days, down from 30, and manufacturers must supply surveillance reports within 3 days of a request. The same notice says manufacturers must actively collect and assess real-world performance data, and summarise device performance over time.
The GOV.UK guidance page, first published 15 January 2025 and last updated 5 September 2025, describes the rules as a new Part 4A inserted into the UK Medical Devices Regulations 2002. They cover devices placed on the Great Britain market. We make no statement about Northern Ireland, and we are not your regulatory adviser; confirm scope with your regulatory team. Neither page mentions capacitors or any electronic component. The link to parts is our own reasoning: a part you cannot trace and cannot swap quickly is a part you will explain under a short deadline.
| Point | What the source says | Source date | Match / mismatch |
|---|---|---|---|
| Entry into force | Post-market surveillance rules in force in Great Britain | MHRA, 16 June 2025 | Match for context only |
| Serious incident reports | 15 days, previously 30 | MHRA, 16 June 2025 | Mismatch with any component claim: no part is named |
| Reports on request | Surveillance reports within 3 days | MHRA, 16 June 2025 | Mismatch: no electronic component is mentioned |
| Legal form | New Part 4A in the 2002 Regulations | GOV.UK guidance, updated 5 September 2025 | Match for context only |
How many stocked Walsin MLCC lines have no second part?
234 of 764. We joined our stock list, dated 23 September 2026, to the MLCC export and matched 764 part numbers. We then grouped the whole export on five fields, size, dielectric, capacitance, tolerance and rated voltage: 234 stocked lines are alone in their group, 530 share it with at least one other part number. Of the 530, only 3 have a sibling in their own series (0201X153K100, 1210B274K451 and 1808B102K302). The other 528 reach a sibling only through another series, most often the automotive MT series (319 lines) or the soft termination SH series (229 lines).
The 234 without a sibling are 137 general purpose, 77 middle and high voltage, 14 microwave, 2 high temperature, 2 safety, 1 big size and 1 ultra microwave line. We have not seen this counted anywhere. A different series means a different datasheet, and so a different change record on your side.
| Stocked lines | Count | Match / mismatch |
|---|---|---|
| Matched to the export | 764 | Reference set, stock as at 23 September 2026 |
| No part sharing all five fields | 234 | Mismatch: a change means a new design decision, not a swap |
| At least one sibling on all five fields | 530 | Match on five fields; series, thickness and datasheet still differ |
| Sibling inside the same series | 3 | Match on five fields and series |
| Sibling only in another series | 528 | Match on five fields; mismatch on series |
Which worked part numbers show a sibling, and what differs?
Take the stocked 0201 line 0201B472K100: 4,700 pF, X7R, plus or minus 10 percent, 10 V. Its only sibling is MT03B472K100, the AEC-Q200 compliant automotive series; the five fields match, the series does not, and the export prints no thickness for the MT part. Take the stocked 0402 line 0402X474K6R3: its sibling SH15X474K6R3 is soft termination, with a printed thickness of 0.50 plus or minus 0.20 mm against 0.50 plus or minus 0.05 mm. The last column is for your incumbent part.
| Walsin part | Series as exported | Size, dielectric, value, tolerance, voltage | Match / mismatch | Your incumbent |
|---|---|---|---|---|
0201B472K100 |
General Purpose | 0201, X7R, 4,700 pF, 10%, 10 V | Reference line, stocked | |
MT03B472K100 |
Automotive MT (AEC-Q200 compliant) | Same five fields | Match on five; mismatch on series; thickness not exported | |
0402X474K6R3 |
General Purpose | 0402, X5R, 470 nF, 10%, 6.3 V | Reference line, stocked | |
SH15X474K6R3 |
Soft Termination SH | Same five fields | Match on five; mismatch on series and thickness tolerance (0.50 ±0.20 mm) | |
2220B104K102 |
Big sizes | 2220, X7R, 100 nF, 10%, 1000 V | Reference line, stocked | |
SH55B104K102 |
Soft Termination SH | Same five fields | Match on five and on printed thickness (2.00 ±0.20 mm); mismatch on series | |
2220B474K101 |
Big sizes | 2220, X7R, 470 nF, 10%, 100 V | Stocked; no sibling in the export | |
0402B103K100 |
General Purpose | 0402, X7R, 10 nF, 10%, 10 V | Stocked; no sibling in the export |
A sibling is a catalogue match on five fields. It is not a qualification, and nothing in the export tells you about dielectric behaviour under bias, aging or failure rate. Our post on why soft termination exists sets out what the SH series changes, our soft termination series guide compares SH, SG and ST, and the MLCC range page lists the families.
What do Walsin’s documents say about medical use?
Nothing. We converted all 28 Walsin datasheets we hold, 451 pages, to text and searched them: medical, healthcare, implant, life support and ISO 13485 each appear in 0 of 28 files. Walsin’s own sheets frame its MLCC series around consumer, industrial and automotive uses. We hold no statement that any series is intended, tested or approved for a medical device.
Venatech holds none of ISO 13485, ISO 9001 or IATF 16949. We can offer lot and date-code traceability and a certificate of conformity per shipment on request; whether that satisfies your supplier file is for your quality team to say.
What will we not tell you about the United Kingdom?
Anything about UK medical device law beyond the two pages cited below. We hold no office, entity or stock in the United Kingdom; our locations are Hong Kong, Shenzhen, Singapore and Jiangmen, with Chengdu in preparation. We state no duty rate, import procedure, transit time or carrier, and we give no legal or customs advice; confirm with your compliance team. We make no claim that any part is approved for a medical device.
How Venatech helps
Start with your incumbent. Paste the capacitor into the free cross-reference tool, which decodes 18 manufacturers’ part numbers across 800,000+ crossable parts and lists Walsin candidates with match and mismatch fields, or upload your list to the BOM checker, up to 500 part numbers. The Hong Kong ready-stock list is a dated snapshot, 23 September 2026, never live-synced. Walsin is the only line we are authorised for; Stackpole and Viking are lines we supply. We work from Hong Kong, in small lots, and you can request a quote through the site. The worked table above came straight from our export: send us one line and we return the same view for your part. Qualification stays with you.
The short version
For a United Kingdom medtech bill of materials, the question is not whether a part exists but whether a second one does. 234 of 764 stocked MLCC lines have none on five fields, and 528 of the 530 that do cross into another series. Of 28 Walsin datasheets, 0 mention medical use, and we hold no ISO 13485.
Send us the ten MLCC lines your quality file would find hardest to replace. We will tell you which have a sibling and which do not. Would you rather learn that today or on day 15 of an incident clock?
Sources
Fetched 23 October 2026. The regulatory statements come from these pages; the counts come from our own Walsin export, datasheets and stock list.
- MHRA, “First major overhaul of medical device regulation comes into force across Great Britain”, dated 16 June 2025: https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain
- GOV.UK, “Post-market surveillance requirements for medical devices: summary of main changes”, published 15 January 2025, updated 5 September 2025: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes
Frequently asked questions
What changed for UK medical device makers on 16 June 2025?
The MHRA announced that post-market surveillance rules took effect in Great Britain, with serious incident reports due in 15 days instead of 30 and surveillance reports due within 3 days of a request. The pages name no electronic component. Confirm scope with your regulatory team.
How many stocked Walsin MLCC lines have no second part?
234 of 764 matched lines, as at 23 September 2026, share no size, dielectric, capacitance, tolerance and rated voltage with any other part in the export. A further 530 have at least one sibling, and 528 of those reach it only through another series.
Is a sibling part a safe replacement?
No. A sibling matches on five catalogue fields. It differs in series, may differ in thickness and datasheet, and has not been qualified in your circuit. Treat it as a candidate for your own qualification, not a swap.
Do Walsin datasheets mention medical use?
No. We searched all 28 datasheets we hold, 451 pages, for medical, healthcare, implant, life support and ISO 13485: 0 of 28 contain any. Whether a series suits your device class is a question for Walsin in writing and your regulatory team.
Does Venatech hold ISO 13485?
No. We hold none of ISO 13485, ISO 9001 or IATF 16949. We offer lot and date-code traceability and a certificate of conformity per shipment on request, and you decide whether that meets your supplier file.
Do you give UK regulatory or customs advice?
No. We hold no office or stock in the United Kingdom and state no duty, import procedure or transit time. Confirm those points with your compliance team. We supply parts, documents we hold, and cross-reference help.