Medical device electronics for Canada are about to meet a new supplier-record rule, and the component that squeezes a wearable board first is the bulk capacitor. We counted the Walsin Technology (Walsin) MLCC export: 9 of 293 part numbers at 10 microfarad or more have a nominal height under 0.6 millimetre, all are 0402, and 1 is on our Hong Kong shelf.
Venatech Limited, an authorised Walsin distributor in Hong Kong, holds the Walsin MLCC export of 24,026 rows (23,601 distinct part numbers) and a stock list dated 23 September 2026. This post is for a design, quality or sourcing engineer at a Canadian medical device maker who needs a small, tall-capacitance part for a battery-powered or wearable board and a documented record of where it came from. Every part number is real, every count is ours, and each regulatory statement names its source and the day we fetched it, 23 October 2026.
What changes for Canadian medical device licence holders on 14 December 2026?
A supplier record becomes mandatory. Final amendments to the Medical Devices Regulations were published in Canada Gazette, Part II on 17 June 2026 and come into force on 14 December 2026, requiring establishment licence holders to submit a list of their non-manufacturer suppliers and to keep documented procedures, while some foreign distributors no longer need their own licence.
The detail, from the sources we fetched. A Health Canada bulletin page dated 17 June 2026 gives the Gazette Part I pre-publication of 8 November 2025, the final publication of 17 June 2026 and the 14 December 2026 start, 180 days later. A law firm article dated 29 June 2026 adds that the supplier list replaces a voluntary arrangement in place since February 2020, that it must include each supplier’s name, address and the risk class of the devices, and that the attestation requirement is replaced by documented procedures for distribution records, incident reporting and servicing. A separate regulatory news note dated 2 April 2026 lists new Health Canada guidance published in March and April 2026, including one on how to interpret a significant change that triggers a licence amendment.
We draw one conclusion, and it is ours: the licence holder in these rules is a device importer or distributor, not a component maker, so a capacitor supplier is not the subject. But a device maker with documented procedures and a changing component record will ask its capacitor supplier for lot and date-code traceability and a certificate of conformity, which we offer on request. We have no relationship with Health Canada or any Canadian device maker.
Why does a wearable board squeeze the bulk capacitor?
Because capacitance and height pull against each other. Across the whole Walsin MLCC export, 293 distinct part numbers reach 10 microfarad or more, and the thinnest nominal body height in each case size runs from 0.50 millimetre at 0402 and 0.80 millimetre at 0603 up to 2.80 millimetre at 2225.
We parsed all 24,026 rows of the Walsin MLCC export, 00_ALL_MLCC_parts_combined.xlsx. The 293 split by case size as 9 at 0402, 20 at 0603, 56 at 0805, 83 at 1206, 104 at 1210, 2 at 1812, 18 at 2220 and 1 at 2225. Of the 293, 19 are on our shelf as at 23 September 2026. We have not seen this cut counted anywhere; it matters because a board that cannot grow in height has only the 0402 row to choose from, and that row is nine parts.
One caution on height. The export prints the 0402 parts as 0.50 plus or minus 0.20 millimetre, so the nominal figure we filter on is not a maximum; the upper limit of that tolerance is 0.70 millimetre. Read the tolerance on the thickness, not the nominal alone, and check the dimension table in the Walsin General Purpose datasheet for your part.
Which Walsin 0402 parts cross a 10 microfarad, 6.3 volt thin-board brief?
Five candidates, two on the shelf, and only one of those is the right size. Take an 0402, X5R, 10 microfarad, plus or minus 20 percent, 6.3 volt brief at about 0.5 millimetre: 0402X106M6R3 matches on all six fields, and neighbours differ in voltage, dielectric, capacitance or height.
| Walsin part | Size, dielectric, capacitance, voltage, height | On shelf 23 Sep 2026 | Match / mismatch with the brief | Your incumbent |
|---|---|---|---|---|
0402X106M6R3 |
0402, X5R, 10 uF, 6.3 V, 0.50 plus or minus 0.20 mm | No | Match on size, dielectric, capacitance, tolerance, voltage and height | |
0402S106M6R3 |
0402, X6S, 10 uF, 6.3 V, 0.50 plus or minus 0.20 mm | No | Mismatch: X6S dielectric, not X5R | |
0402X226M6R3 |
0402, X5R, 22 uF, 6.3 V, 0.50 plus or minus 0.20 mm | Yes | Mismatch: 22 uF, more than the brief | |
0402X106M100 |
0402, X5R, 10 uF, 10 V, 0.50 plus or minus 0.20 mm | No | Mismatch: 10 V rating, higher than the brief | |
0603X106M6R3 |
0603, X5R, 10 uF, 6.3 V, 0.80 plus or minus 0.20 mm | Yes | Mismatch: larger body and taller |
The 22 microfarad part is the only 0402 at 10 microfarad or more on the shelf, and it is the one that does not match a 10 microfarad brief; if your circuit can use the larger value, ask us. Our post on NP0, X7R and X5R dielectrics explains why the dielectric letter matters, and we give no derating figure here because none is in the export.
What does a Hong Kong shelf hold for a thin Canadian medical board?
One 0402 line out of nine. Of the 9 Walsin parts at 10 microfarad or more under 0.6 millimetre nominal, all 0402, 1 is on our stock list as at 23 September 2026: 0402X226M6R3; the shelf also holds four 0603 lines at 10 microfarad and one at 22 microfarad, all 0.80 millimetre nominal.
Stock moves; the ready stock list is a dated snapshot, never live-synced. Our post on Walsin passive components in Hong Kong stock covers the shelf, and the MLCC range lists the families. We hold lot and date-code traceability, a certificate of conformity per shipment on request and original sealed Walsin packaging.
What will we not tell you about medical device compliance in Canada?
Anything about classification, licensing or suitability. We make no claim that any Walsin part is suitable for a medical device, we hold no ISO 13485 or ISO 9001 certificate, and none of the 28 datasheets we hold mentions ISO 13485, an implant or biocompatibility.
We hold no office, entity or stock in Canada. Our locations are Hong Kong, Shenzhen, Singapore and Jiangmen, with Chengdu in preparation. We give no legal, customs or conformity advice; confirm with your compliance team. Qualification stays with you.
How Venatech helps
Paste your incumbent into the free cross-reference tool, which decodes 18 manufacturers’ part numbers across 800,000+ crossable parts, and read the Walsin candidates with each field marked match or mismatch. Load a whole BOM, up to 500 part numbers or an Excel or CSV file, to run every line. The ready-stock list is a Hong Kong snapshot dated 23 September 2026, never live. Worked example from our own export: the 10 microfarad or more filter above returned 303 rows and 293 distinct part numbers, nine of them under 0.6 millimetre nominal, and our shelf covers one of the nine. Walsin is the only line we are authorised for; Stackpole and Viking are lines we supply. We serve from Hong Kong in small lots, we help with cross-referencing by hand when the tool returns no clean candidate, and a quote is requested through the site. The 28 datasheets, 451 pages, we hold are sent on request.
The short version
For a Canadian medical device maker, the new supplier-record rule starts in December 2026 and the thin-board capacitor choice is narrow: 9 of 293 parts at 10 microfarad or more are under 0.6 millimetre nominal, all 0402, with 1 on the shelf. The electrical cross is quick, and the paper trail is the half you build.
Send us one bulk capacitor from your BOM and we will return the Walsin candidates with the differences stated and the shelf position named. When your documented procedures ask for a supplier record, which capacitor line on your board has the thinnest one?
Sources
Fetched 23 October 2026.
- Health Canada, “Phase 2 of our work to modernize medical device establishment licensing”, page dated 17 June 2026: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/phase-two-our-work-modernize-licensing.html
- Torys, “Canada’s amended Medical Devices Regulations”, 29 June 2026: https://www.torys.com/en/our-latest-thinking/publications/2026/06/canadas-amended-medical-devices-regulations
- NSF, “New Health Canada guidance documents for medical devices published March and April 2026”, 2 April 2026: https://www.nsf.org/au/en/life-science-regulatory-news/new-health-canada-guidance-documents-medical-devices-published-march-april-2026
Frequently asked questions
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When do the amended Canadian medical device establishment licence rules take effect?
According to a Health Canada page dated 17 June 2026, the amendments were published in Canada Gazette, Part II on 17 June 2026 and come into force on 14 December 2026, 180 days later. Confirm the dates and your licence class with your regulatory team.
What does the Canadian supplier list require?
A law firm article dated 29 June 2026 says licence holders must list each non-manufacturer supplier with name, address and device risk class, with the application and updated annually. That is the source’s description, not ours. Confirm with your regulatory team.
How many Walsin MLCC reach 10 microfarad, and how many are thin?
293 distinct part numbers in the export reach 10 microfarad or more, and 9 of them have a nominal height under 0.6 millimetre. All 9 are 0402. We counted them ourselves from the 24,026-row export.
Which Walsin part crosses an 0402, X5R, 10 uF, 6.3 V brief?
0402X106M6R3 matches on size, dielectric, capacitance, tolerance and voltage, and is not on our shelf as at 23 September 2026. 0402X226M6R3 is 22 uF and is on the shelf. Confirm against both datasheets and qualify in your own circuit.
Do you hold ISO 13485 or claim medical suitability?
No. We hold no ISO 13485 or ISO 9001 certificate, and none of the 28 datasheets we hold mentions ISO 13485, an implant or biocompatibility. We make no claim that any part is suitable for a medical device. Qualification and classification stay with you.
Do you hold stock in Canada or give regulatory advice?
No. We hold no office, entity or stock in Canada; our locations are Hong Kong, Shenzhen, Singapore and Jiangmen. We give no legal, customs or conformity advice. Confirm with your compliance team. We offer lot and date-code traceability and a certificate of conformity per shipment on request.