Fizza Surgical exports TGA-compatible surgical instruments to Australian hospitals, state health departments, medical distributors, and private surgical centres. Australia imports the majority of its surgical instruments — and Sialkot, Pakistan is among the world’s primary sources. Our ISO 13485:2016 and CE marking documentation is accepted by the Therapeutic Goods Administration (TGA) as a conformity assessment pathway.

TGA Regulatory Pathway for Surgical Instruments

• Surgical instruments must be included in the Australian Register of Therapeutic Goods (ARTG) before supply in Australia
• The Australian sponsor (local importer or distributor) is responsible for ARTG registration
• TGA accepts CE marking under EU MDR 2017/745 as a conformity assessment option for Class I–IIb devices
• Fizza Surgical provides all manufacturer-level documentation required for TGA submission: ISO 13485 certificate, EC Declaration of Conformity, technical specifications
• Most general surgical instruments are classified as Class I under the TGA scheme

State Procurement

Fizza Surgical has experience supplying Australian state health procurement frameworks. We provide documentation in Australian Health Procurement formats and can supply instruments under existing distributor relationships. Key procurement bodies: NSW Health, Queensland Health, Department of Health WA, SA Health.

Duty and Shipping

Pakistan benefits from the Australian GSP (Generalised System of Preferences), meaning 0% import duty on surgical instruments (HS 9018) from Pakistan. DHL Express: Sialkot to Sydney or Melbourne in 4–5 business days. Canberra, Brisbane, Perth, Adelaide: 5–6 business days.