Fizza Surgical International manufactures private-label surgical instruments for distributors, hospital groups, and medical device companies in 50+ countries. Our OEM service covers the full range of surgical, dental, orthopedic, veterinary, laryngoscope, and beauty instruments — over 25,000 SKUs, all manufactured to ISO 13485:2016 quality standards with CE Mark under EU MDR 2017/745.
Minimum order quantity from 300 units per SKU. Standard lead time 6–8 weeks from confirmed order. Custom packaging, branded labeling, and country-specific compliance documentation are included.
Who Buys OEM Surgical Instruments From Us
- Surgical instrument distributors in the EU, US, Middle East, and Asia-Pacific who need consistent supply with their own brand on the product
- Hospital procurement groups sourcing private-label instruments to standardize across multi-facility networks
- Medical device startups launching instrument lines without building manufacturing infrastructure
- Veterinary supply companies branching into surgical instruments
- Beauty and aesthetic device companies requiring forceps, scissors, and dermal instruments under their own labels
Whether you need 300 hemostatic forceps for a single hospital tender or 50,000 specula across multiple sizes for a national distribution network, the manufacturing process and quality control is the same.
What Sets Our OEM Service Apart
Manufacturing Capability
We manufacture in Sialkot, Pakistan — the global hub for surgical hand instrument production. Around 70% of the world’s surgical hand instruments come out of this region. Our facility runs forging, machining, heat treatment, polishing, and final assembly under one roof. Materials are sourced from European and Japanese steel mills (AISI 420 and AISI 410 martensitic stainless) with mill test reports retained for every batch.
Heat treatment is controlled to deliver 50–56 HRC hardness on cutting and gripping instruments. Surface finish is mirror-polished to Ra ≤ 0.4 µm. Each instrument is laser-marked with the SKU code, lot/batch identifier, and your brand mark. We retain traceability records for every batch for 10 years to support regulatory audits.
Regulatory and Quality Documentation
Every shipment includes the documentation pack required for medical device import in target markets:
- Certificate of Conformity (EU MDR 2017/745)
- ISO 13485:2016 quality management certification (DEKRA)
- FDA Establishment Registration certificate (Reg. No. 3019842214)
- Material test reports (AISI grade verification)
- Sterilization validation data (where the instrument is supplied sterile)
- Country-specific compliance — Japan MHLW, Brazil ANVISA, GCC, etc., where applicable
For your distributor compliance team, we provide a complete technical file on request — drawings, materials specifications, manufacturing process flow, biocompatibility data, and risk management documentation per ISO 14971.
Custom Branding and Packaging
Standard branding options:
- Laser engraving of your logo, brand name, country of origin, and SKU on each instrument
- Custom labeling on the primary pouch, secondary box, and case
- Custom packaging design — sterile pouches, blister packs, instrument trays, presentation cases
- Multi-language IFU (Instructions for Use) printed and inserted with each unit
- Country-specific labeling — barcode standards (GS1, UDI), CE markings, MDR compliance text
Pricing and Lead Time
Pricing is set per SKU based on complexity, material grade, and order quantity. As a guide:
- Standard hand instruments (forceps, scissors, retractors) — competitive with regional manufacturers, 30–50% below European-manufactured equivalents
- Specialized or precision instruments — quoted on technical drawing review
- Volume tiers: pricing breaks at 1,000 / 5,000 / 10,000 units per SKU
Standard lead time: 6–8 weeks from confirmed order with payment received. Sample turnaround for new SKUs: 3–4 weeks. Air freight or sea freight from Karachi or Sialkot Air Cargo.
Product Categories We Manufacture
| Category | SKU range | Typical OEM volume |
|---|---|---|
| General surgical instruments | 5,000+ SKUs | 300–10,000 units per SKU |
| Dental instruments | 3,500+ SKUs | 500–5,000 units per SKU |
| Laryngoscopes | 200+ SKUs | 300–3,000 units per SKU |
| Bone surgery / orthopedic | 2,000+ SKUs | 300–2,000 units per SKU |
| Veterinary instruments | 3,000+ SKUs | 500–10,000 units per SKU |
| Obstetrics & gynecology | 1,500+ SKUs | 500–10,000 units per SKU |
| Hospital holloware | 800+ SKUs | 300–5,000 units per SKU |
Our OEM Process
From first inquiry to first shipment, the process takes 8–12 weeks for an existing SKU and 12–20 weeks for a new custom design. The steps:
- Inquiry and SKU selection. You send your target SKU list (or technical drawings for custom designs) and target market. We respond with quotation and feasibility note within 5 working days.
- Sample approval. We produce 5–10 production samples for your QA evaluation. Sample lead time 3–4 weeks. Cost typically waived against confirmed order.
- Branding finalization. Logo files, packaging artwork, IFU text, and labeling specifications confirmed. We produce printed mock-ups for sign-off.
- Order confirmation and payment. 30% advance, 70% before shipment is the standard term. Letter of credit accepted for orders over USD 50,000.
- Production. 6–8 weeks. We provide weekly progress photos for orders over 5,000 units.
- QC and packaging. 100% visual inspection, statistical sampling for dimensions and surface finish, packaging per agreed specification.
- Documentation pack. Compiled and shipped with the order: invoices, packing list, certificates, test reports, country-of-origin certification.
- Shipment. Air or sea freight per your preference. We handle export documentation; you handle import clearance in your market.
Quality Assurance
Every order goes through three QC checkpoints:
In-process QC — dimensional and material checks at forging, heat-treatment, and machining stages. Out-of-spec parts are pulled before they reach polishing.
Pre-shipment QC — 100% visual inspection of every finished instrument. Sampling per ISO 2859-1 (AQL 1.0) for dimensions, hardness, surface finish, and functional checks (e.g., scissor cutting test, ratchet locking test).
Documentation QC — every box and pouch label cross-checked against SKU specification. Lot numbers verified against production records.
For demanding markets (EU, US, Japan), we also accept third-party pre-shipment inspection by SGS, Bureau Veritas, or your appointed agent. Inspection cost is borne by the buyer; we facilitate factory access and documentation review.
Frequently Asked Questions
What is the minimum order quantity for OEM surgical instruments?
Minimum order quantity is 300 units per SKU for standard products. For custom-designed instruments, the minimum may be higher depending on tooling requirements — typically 500–1,000 units. Mixed-SKU orders are accepted; the 300-unit minimum applies per individual SKU.
What is the lead time for OEM orders?
Standard lead time is 6–8 weeks from confirmed order with payment received. Sample lead time for a new SKU is 3–4 weeks. New custom designs requiring tooling may take 12–16 weeks for the first production run; subsequent re-orders revert to the standard 6–8 week lead time.
Do you provide samples before bulk production?
Yes. We produce 5–10 production samples for your QA team to evaluate before confirming the full order. Sample lead time is 3–4 weeks. Sample cost is typically waived if a production order follows within 90 days; otherwise we charge a nominal fee.
What certifications and documentation do you provide?
Each shipment includes: Certificate of Conformity (EU MDR 2017/745), ISO 13485:2016 certificate (DEKRA), FDA Establishment Registration certificate, material test reports for stainless steel, sterilization validation data where applicable, and country-specific compliance documentation (Japan MHLW, Brazil ANVISA, GCC). Full technical files for regulatory submission are available on request.
Can you provide custom packaging and branding?
Yes. We laser-engrave your logo and branding on each instrument. Packaging is fully customizable — sterile pouches, blister packs, instrument trays, presentation cases. Multi-language IFU sheets are printed and inserted. Country-specific labeling (CE marks, GS1 barcodes, UDI codes) is included as standard.
Where do you ship from?
We ship from Sialkot, Pakistan via air freight (Sialkot International Airport) or sea freight (Karachi Port). Both options are available for every order. Air freight is typical for orders under 1,000 units or urgent shipments; sea freight is more economical for larger volumes. Door-to-door delivery via DHL or FedEx is available for sample orders.
What payment terms do you accept?
Standard terms: 30% advance with order confirmation, 70% balance before shipment. Wire transfer (T/T) is preferred for orders under USD 50,000. Letter of credit (L/C at sight) accepted for larger orders. Established repeat customers may qualify for L/C 30 days or open account terms after a track record is built.
Do you supply sterile-packed instruments?
Yes. We supply both non-sterile (standard) and sterile (gamma-irradiated or ethylene-oxide sterilized) instrument packaging on request. Sterile packaging is contract-manufactured through ISO 13485-certified sterilization partners with full validation documentation.
Can you handle the regulatory submission for our market?
We provide the manufacturer-side technical documentation needed for regulatory submission — technical files, test reports, declarations of conformity, manufacturer’s identification. Country-specific submission (510(k) for FDA, MDR for EU notified body, etc.) is the responsibility of the importer/distributor as the legal manufacturer of record under your brand. We support your regulatory consultant with documentation requests at no cost.
Get a Quote
To start an OEM project, send us your SKU list (or technical drawings for custom designs), target volume per SKU, and target market. We respond with a detailed quotation, lead time, and feasibility note within 5 working days.
Contact: [email protected] | +92-333-843-3925 | contact form
For an immediate technical conversation, message us with your SKU list and we will arrange a call with our production team within 48 hours.
