Quality Certifications & Regulatory Compliance | ISO 13485 & CE

International Compliance Standards

Certified Quality Management for Global Medical Procurement

At Fizza Surgical International, quality assurance is an audited manufacturing discipline embedded into every stage of production. Established in 1980 in Sialkot, Pakistan, our facility operates under rigorous international medical device standards to provide healthcare procurement officers, surgical distributors, and hospital networks with absolute confidence in product safety, traceability, and mechanical performance.

CE Marking — EU MDR 2017/745

European Conformity Certification

Our complete range of reusable surgical, dental, orthopedic, and veterinary instruments carries CE marking in full compliance with Regulation (EU) 2017/745 on medical devices. Registered in EUDAMED, our Class I and Class IIa reusable surgical instruments satisfy stringent European requirements for biocompatibility, ergonomic safety, and sterilisation durability.

Full compliance with EU Medical Device Regulation (EU MDR 2017/745)
Audited technical documentation, UDI management, and clinical evaluations
CE Declaration of Conformity issued with all export consignments
Seamless customs clearance across all European Union member states

ISO 13485:2016 Certification

Medical Device Quality Management System

Independently audited and certified by DEKRA, our ISO 13485:2016 quality management system covers every operational tier — from raw steel inspection and drop-forging to hand grinding, passivation, and final packaging. This certification validates our systematic approach to risk management, batch traceability, and post-market surveillance.

Comprehensive QMS specific to medical device manufacturing
Annual surveillance audits conducted by accredited registrar DEKRA
Strict batch traceability from raw steel mill certificates to finished device
CAPA (Corrective and Preventive Actions) integrated quality protocols

ISO 9001:2015 Certification

Quality Management System Framework

Our ISO 9001:2015 certification underpins our organizational commitment to customer satisfaction, continuous process improvement, and operational accuracy. By standardizing manufacturing workflows, customer communication, and supply chain logistics, we guarantee consistent order fulfillment and high accuracy rates.

International standard for organizational quality management
Standardized order handling, export packing, and delivery verification
Continuous training programs for skilled surgical artisans and QC technicians
Audited supplier evaluation procedures for premium raw materials

US FDA & Global Registrations

United States, Japan MHLW & Brazil ANVISA

Fizza Surgical International holds US FDA Establishment Registration (Registration Number: 3019842214) and operates in full compliance with 21 CFR Part 880 requirements. Furthermore, our products are registered with Japan's Ministry of Health, Labour and Welfare (MHLW) and Brazil's ANVISA, enabling hassle-free international distribution.

FDA Establishment Registration Number: 3019842214
Registered with Japan MHLW for direct hospital import compliance
ANVISA registration approval for South American healthcare markets
Complete documentation support for national health authority tenders

Metallurgical Excellence

German-Grade Stainless Steel & Material Standards

Instrument longevity and corrosion resistance depend heavily on raw material purity and heat-treatment precision. Fizza Surgical exclusively uses certified German and Japanese steel grades conforming strictly to EN ISO 7153-1 specifications.

Material Grade	Metallurgical Type	Standard Applications	Hardness (HRC) / Features	Compliance Standard
AISI 420 (1.4021 / 1.4028)	Martensitic Stainless Steel	Scissors, Scalpels, Bone Cutting Forceps, Rongeurs	50 – 56 HRC (High edge retention & hardness)	EN ISO 7153-1 / ASTM F899
AISI 410 (1.4006)	Martensitic Stainless Steel	Dissecting Forceps, Hemostatic Clamps, Retractors	40 – 48 HRC (Superior tensile strength)	EN ISO 7153-1 / ASTM F899
AISI 304 / 316L	Austenitic Stainless Steel	Hospital Holloware, Sterilisation Trays, Drums, Bowls	Non-magnetic, exceptional chemical & rust resistance	DIN 17440 / ASTM A240
Tungsten Carbide (TC)	Sintered Carbide Inserts	Specialty Needle Holders, Wire Cutters, SuperCut Scissors	70+ HRC (Gold-plated rings for TC identification)	ISO 13779 / DIN Spec

Autoclave & Process Testing

Rigorous Testing & Sterilisation Validation

Every production batch undergoes multi-stage testing prior to packaging to ensure maximum safety in central sterile supply departments (CSSD) worldwide.

EN ISO 13402 Autoclave Testing

Instruments are tested for thermal shock and corrosion resistance under steam autoclaving cycles at 134°C (273°F) for 18 minutes, ensuring zero pitting, staining, or structural degradation.

Passivation & Boil Test

Chemical passivation removes free iron particles from instrument surfaces. Boil testing according to ASTM C1193 verifies the formation of a self-healing chromium oxide passive layer.

Batch Material Traceability

Raw steel heat numbers are linked directly to finished lot numbers. Full steel mill test certificates (MTC) detailing chemical composition are archive -kept and provided upon request.

Regulatory FAQ

Frequently Asked Questions Regarding Our Certifications

Answers to common verification, compliance, and export documentation questions asked by healthcare procurement officers and OEM buyers.

We provide official, unredacted copies of our ISO 13485:2016, ISO 9001:2015, and CE Certificates of Conformity upon request. Certificates feature accredited registrar verification codes, allowing direct validation through DEKRA and notified body portals.

Yes. Every export shipment includes full material test certificates (MTC) verifying AISI 420 martensitic or AISI 316L austenitic stainless steel chemical composition, hardness values (HRC), and corrosion resistance standards compliant with EN ISO 7153-1.

All reusable surgical, dental, and medical instruments manufactured by Fizza Surgical comply fully with EU MDR 2017/745 as Class I and Class IIa reusable devices, backed by complete technical documentation and EUDAMED listing.

Yes. Fizza Surgical holds US FDA Establishment Registration (3019842214), Japan Ministry of Health, Labour and Welfare (MHLW) registration, and Brazil ANVISA approval, allowing smooth customs clearance and compliant distribution.

Request Certification Documents & Technical Dossiers

Need original ISO 13485 certificates, CE Declarations of Conformity, or material test reports for hospital tenders and health authority registrations? Contact our export compliance team today.

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