A distributor supplying three private hospitals around Ho Chi Minh City had a container of surgical blades held at Cat Lai port in February — not because anything inside was unsafe, but because the import dossier still referenced a license format that Decree 04/2025/NĐ-CP had already put on a hard expiry clock. Nobody on the logistics side had actually read the amendment; they'd just kept re-filing last year's paperwork. That kind of gap is becoming more common exactly as Vietnam's hospitals and ambulatory surgery centers move away from resharpened, reprocessed scalpel blades toward sterile single-use ones — a market shift that makes the regulatory fine print matter more, not less.
Decree 04/2025 didn't rewrite Vietnam's medical device rules from scratch, but it changed deadlines, a licensing portal, and the approval chain right as hospitals pull away from resharpened blades toward single-use. Distributors relying on last year's paperwork are the ones getting held at port.
Decree 04/2025/NĐ-CP, issued and effective 1 January 2025, is the third amendment to Vietnam's core medical device law, Decree 98/2021/NĐ-CP (itself already amended by Decree 07/2023/NĐ-CP). It is a narrower, more technical update than its name suggests: its main substantive provision extends the validity of certain legacy import licenses and in vitro diagnostic registration numbers, issued between 2014 and 2021, through 30 June 2025, rather than rewriting Vietnam's classification or registration framework outright. But narrow doesn't mean low-stakes — the decree lands inside a broader run of changes to how Vietnam processes medical device paperwork, and importers who treat it as a footnote are the ones who get a shipment flagged.
Since 1 January 2025, medical device licensing in Vietnam runs primarily through the Infrastructure and Medical Device Administration (IMDA) portal at imda.moh.gov.vn, which replaced the legacy dmec.moh.gov.vn system that had run in parallel through the end of 2024. Circular 44/2025/TT-BYT, effective 22 November 2025, layered a further change on top: it decentralizes a number of Ministry of Health administrative procedures out to IMDA and to provincial health departments, meaning approvals that used to route only through Hanoi headquarters can now move through different regional channels — a detail that changes expected turnaround times, not just the letterhead on the certificate. Vietnamese legal commentary on the 2025–2026 transition also flags a harder deadline ahead: from August 2026, Class C and D medical device imports must rely strictly on officially registered circulation numbers, closing the extended legacy import-license pathway that Decree 04/2025 had temporarily kept open.
Vietnam classifies medical devices into four risk tiers — A, B, C, D — aligned with the ASEAN Medical Device Directive. Published guidance on the system places items like surgical gauze, conventional examination gloves, and basic hospital beds in Class A, and items like catheters, syringes, and needles in Class B, with X-ray and imaging equipment in Class C and implantable, life-support devices in Class D. A sterile single-use surgical blade sits closer to the needle/catheter category than to gauze — it's an invasive, sharp instrument intended for immediate use on a patient — but the exact classification is a case-by-case determination made by an MOH-accredited classification body, not something a distributor should assume from the product category. Getting that classification opinion in writing determines whether the import route is Class A's simpler declaration of applied standards (filed at the provincial Department of Health) or Class B's marketing-authorization/circulation-number process. Surgical instruments generally also carry HS heading 9018.90.90 under the standardized device-HS code list in Circular 19/2024/TT-BYT (effective 16 November 2024); customs at ports like Cat Lai cross-checks that HS code against the MOH classification result, and a mismatch is one of the more common triggers for a red-channel physical inspection.
Get the classification opinion in writing and match it to your HS code before a container leaves port. Browse our sterile surgical blades range, check the certifications documentation your distributor's classification body will ask for, or request a quote sized to a single ASC order or a multi-hospital distributor booking.
The regulatory changes are landing on top of a real shift in buying behavior. Within Vietnam's general surgery devices market, market research firm Ken Research reports that the single-use share of standardized procedure volume rose from 54% in 2020 to 63% in 2025 — a five-year swing away from resharpened, reprocessed instruments toward disposables. The same research notes that more than 90% of Vietnam's broader medical equipment and supply demand is import-dependent, meaning almost none of that swing can be absorbed by domestic manufacturing capacity. Vietnam's surgical instruments market specifically was estimated at roughly $211 million in 2025, projected to grow past $490 million by 2034, while the narrower general surgery devices segment was estimated near $75 million in 2025. Ken Research also puts the country's hospital count at 1,645 in 2024, including 384 private hospitals — and private and ambulatory facilities are typically the segment least equipped to run in-house reprocessing and resharpening operations, which is part of why they lean toward single-use in the first place.
| Item | Detail |
|---|---|
| Governing framework | Decree 98/2021/NĐ-CP, amended by Decree 07/2023/NĐ-CP and Decree 04/2025/NĐ-CP (effective 1 Jan 2025) |
| Licensing portal | IMDA — imda.moh.gov.vn (live since 1 Jan 2025; replaced legacy dmec.moh.gov.vn) |
| Latest procedural update | Circular 44/2025/TT-BYT (effective 22 Nov 2025) — decentralizes MOH administrative procedures |
| Legacy license/IVD registration deadline | Extended to 30 June 2025 under Decree 04/2025 |
| Hard deadline ahead | From August 2026, Class C/D imports need a registered circulation number — no further extensions reported |
| Device classification system | Four-tier A/B/C/D, aligned with the ASEAN Medical Device Directive (AMDD) |
| Typical HS heading, surgical instruments | 9018.90.90 (Circular 19/2024/TT-BYT device-HS code list, effective 16 Nov 2024) |
| Vietnam surgical instruments market size | ~$211 million (2025), projected toward ~$490 million by 2034 |
Pricing on sterile surgical blades varies with steel grade, packaging format, and order volume. Indicative export-listing ranges from Indian manufacturers show a wide spread between bulk carbon-steel boxes and individually foil-wrapped sterile pieces built for single-procedure kits — the kind of format ambulatory surgery centers increasingly ask for.
| Blade format | Indicative FOB India export range* | Typical buyer fit |
|---|---|---|
| Carbon steel blades, bulk box (~100 pcs) | $1.50 – $3.00 per box | High-volume general hospital wards |
| Stainless steel blades, bulk box (~100 pcs) | $2.50 – $4.50 per box | Private hospitals, standard OR use |
| Individually foil-wrapped sterile blades | $0.15 – $0.30 per piece | Ambulatory surgery centers, single-procedure kits |
| Specialty/precision blades (ophthalmic, micro) | $0.30 – $1.00+ per piece | Aesthetic, ophthalmic, plastic surgery clinics |
*Figures are indicative, drawn from public B2B export listings rather than fixed quotes — confirm landed cost against your exact spec and volume before committing a container.
As hospitals decide whether to renew in-house reprocessing and resharpening contracts or move a department to disposables outright, distributors are often the ones asked to lay out the trade-off in plain terms.
| Factor | Reusable/resharpened blades | Single-use sterile blades |
|---|---|---|
| Per-procedure cost | Lower unit cost, but a recurring reprocessing/resharpening fee applies | Higher unit cost, no reprocessing fee |
| Infection control | Depends on reprocessing quality control at the facility | Sterile at point of use; no reprocessing-failure exposure |
| Regulatory obligation | Same MOH classification and registration requirements apply | Same MOH classification and registration requirements apply — going disposable doesn't reduce the dossier |
| Facility fit | Works where in-house CSSD/reprocessing capacity exists | Better fit for ASCs and private clinics without in-house reprocessing |
| Vietnam market direction | Shrinking share per Ken Research (54% → 63% single-use, 2020–2025) | Growing share of standardized procedure volume |
A decree that only extends a deadline doesn't feel like news until the deadline arrives and half the shipments in transit are still carrying the paperwork it replaced. The importers caught out by Decree 04/2025 weren't ignoring Vietnamese law — they were relying on a portal and a license format that had already been quietly retired.
None of this replaces registration work specific to your buyer's exact product code and classification opinion. But Vietnam's medical device framework keeps moving even when the headline change looks small, and a distributor who treats a decree amendment as a formality is the one left explaining a port hold to a hospital client waiting on an OR schedule.
It's the third amendment to Decree 98/2021/NĐ-CP (following Decree 07/2023/NĐ-CP), issued and effective 1 January 2025. Its core provision extends the validity of certain legacy import licenses and in vitro diagnostic registration numbers, issued between 2014 and 2021, through 30 June 2025, rather than rewriting Vietnam's classification or registration framework outright.
It depends on the specific product's classification opinion. Vietnam's four-tier A/B/C/D system, aligned with the ASEAN Medical Device Directive, places items like gauze and conventional gloves in Class A and items like catheters, syringes and needles in Class B. A sterile single-use surgical blade should be classified case-by-case by an MOH-accredited classification body, not assumed from its category.
Since 1 January 2025, Vietnam's Infrastructure and Medical Device Administration (IMDA) runs the primary licensing portal at imda.moh.gov.vn, which replaced the legacy dmec.moh.gov.vn system that operated in parallel through the end of 2024.
Market research from Ken Research shows the single-use share of standardized procedure volume in Vietnam's general surgery devices market rose from 54% in 2020 to 63% in 2025. Private hospitals and ambulatory facilities, which more often lack in-house reprocessing capacity, are a growing share of the 1,645 hospitals reported nationally in 2024.
Surgical instruments generally fall under HS heading 9018.90.90 per the standardized device-HS code list issued in Circular 19/2024/TT-BYT (effective 16 November 2024). The exact code should still be confirmed against your product's classification result, since HS code and MOH classification mismatches are a common cause of customs holds.
Vietnamese legal commentary on the 2025–2026 transition indicates that from August 2026, Class C and D medical device imports must rely strictly on officially registered circulation numbers, closing out the extended legacy import-license pathway that Decree 04/2025 kept open temporarily.
Yes. Classification and registration requirements apply based on the device's risk class and intended use, not on whether it's reusable or single-use. Switching a hospital department from resharpened to disposable blades doesn't reduce the regulatory dossier a distributor needs to hold.
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