Pintech Instruments exports ISO 13485 certified surgical, dental, beauty and veterinary instruments factory-direct to distributors, hospitals and brands across 50+ countries. Full regulatory documentation โ FDA, CE, TGA, UKCA, SAHPRA, NAFDAC โ tailored to every market we serve.
We don't just ship instruments โ we provide the exact regulatory documentation your market requires. Select your region to see what documentation is included.
FDA Registered ยท ISO 13485 ยท No import duty (HS 9018) ยท DHL 5โ7 days
The USA is the world's largest surgical instrument import market. Pintech instruments are exported to US surgical distributors, hospital GPOs, ambulatory surgical centers (ASCs), dental supply companies and OEM brands under FDA Establishment Registration. Standard surgical instruments are Class I devices (510k exempt) โ no pre-market approval required.
Canada's medical device market is regulated by Health Canada under the Medical Devices Regulations (SOR/98-282). Surgical instruments are Class IโII medical devices. Pintech provides ISO 13485 and CE documentation supporting Health Canada MDL applications for Canadian distributors and healthcare buyers.
CE Marked (EU MDR) ยท UKCA Compatible ยท ISO 13485 ยท DHL 3โ6 days
The UK is a major market for Pintech instruments โ supplying NHS Trusts, private hospital groups (Spire, BMI, Nuffield), day surgery centres and dental distributors. Our instruments are CE marked and UKCA compatible under current UKCA transitional arrangements, with full documentation for NHS Supply Chain procurement frameworks.
Germany is Europe's largest surgical instrument market and also a major hub for instrument rebranding and OEM distribution. Pintech supplies German distributors with CE marked instruments under EU MDR 2017/745, with full Declaration of Conformity and technical file documentation. Our instruments meet DIN and EN ISO standards equivalent to German-manufactured instruments.
๐ช๐บ Other European Markets โ CE Documentation Provided:
TGA (Australia) ยท Vietnam MOH ยท ASEAN AMDD ยท PMDA (Japan) ยท MFDS (South Korea)
Australia's TGA accepts CE marking as evidence of conformity for Class IIa medical devices โ covering the majority of surgical instruments. Pintech provides a complete TGA-compatible documentation package enabling Australian sponsors to pursue ARTG registration efficiently. We supply hospitals, day procedure centres, dental groups and distributors across NSW, VIC, QLD, WA, SA and NT.
Vietnam's medical device regulations (Decree 98/2021) and the broader ASEAN Medical Device Directive framework are well-understood by Pintech's compliance team. We provide CSDT (Common Submission Dossier Template) documentation supporting registration across Vietnam, Thailand, Malaysia, Indonesia, Philippines and Singapore.
๐ Other Asia Pacific Markets:
SFDA (Saudi) ยท DHA / MOH (UAE) ยท Gulf MDS ยท ISO 13485 ยท CE ยท DHL 3โ5 days
Saudi Arabia is one of the fastest-growing medical device markets in the world. Pintech supplies Saudi Ministry of Health procurement, major hospital groups and surgical distributors. Our instruments meet SFDA (Saudi Food and Drug Authority) requirements with ISO 13485 and CE documentation, and are compatible with the Gulf Cooperation Council (GCC) Medical Devices Regulation.
The UAE is a major re-export hub for the wider Middle East region. Pintech serves UAE distributors (Dubai, Abu Dhabi, Sharjah) who distribute to hospitals and clinics across the GCC, Levant and North Africa. We provide documentation compatible with DHA, MOH UAE, HAAD and Gulf MDS requirements.
SAHPRA ยท NAFDAC ยท PPB ยท Ghana FDA ยท TMDA ยท NDA ยท 10+ countries
Africa is a significant and growing market for Pintech instruments โ supplying healthcare distributors, government hospital procurement agencies, NGO healthcare programs and private healthcare networks. We understand the regulatory requirements for all major African healthcare markets and provide market-specific documentation.
Our regulatory compliance capability covers every major surgical instrument import market in the world โ from the FDA in the USA to SAHPRA in South Africa.
Quality management system for medical device manufacturers โ accepted as evidence of compliance in virtually every regulated market globally.
USA ยท UK ยท EU ยท Australia ยท Canada ยท all marketsEuropean Conformity under EU Medical Device Regulation 2017/745. Accepted by TGA (Australia), Swissmedic (Switzerland) and other harmonised markets.
EU ยท UK ยท Australia ยท Switzerland ยท NorwayUS FDA Establishment Registration for export of Class I surgical instruments to the United States. No 510(k) required for standard handheld surgical instruments.
United States ยท Class I 510(k) exemptUK Conformity Assessed โ compatible documentation under UKCA transitional arrangements. Full support for NHS Supply Chain procurement and MHRA compliance.
United Kingdom ยท NHS Trusts ยท Private hospitalsCE + ISO 13485 accepted by Australia's Therapeutic Goods Administration for Class IIa surgical instruments under mutual recognition arrangements. ARTG support docs provided.
Australia ยท New Zealand (Medsafe)Market-specific documentation for SAHPRA, NAFDAC, PPB, Ghana FDA, TMDA (Africa) and Vietnam MOH, ASEAN AMDD, CSDT dossier support for Southeast Asia.
10+ African countries ยท 10 ASEAN countriesPintech Instruments has been exporting surgical, dental and beauty instruments from Sialkot, Pakistan to international markets since 2008. Over 47 years of manufacturing experience โ combined with ISO 13485 certification, CE marking, FDA establishment registration and market-specific regulatory documentation โ makes Pintech one of the most comprehensively certified instrument manufacturers available for international wholesale buyers.
Sialkot, Pakistan is responsible for producing an estimated 20โ25% of all surgical instruments manufactured globally. The city's instrument industry traces its origins to the 1880s โ over 140 years of accumulated metalworking expertise, specialist forging capability and precision grinding skills concentrated in a single industrial cluster. This history results in instruments of equivalent quality to European-manufactured products at 40โ70% lower factory cost โ making Sialkot the preferred source for instrument distributors across every continent.
Pintech Instruments combines Sialkot's manufacturing advantages with rigorous ISO 13485 certified quality management โ ensuring that every instrument leaving our factory meets the dimensional, functional and material specifications required for clinical use in hospitals and surgical centres worldwide.
What sets Pintech apart from most Sialkot manufacturers is our ability to provide complete, market-specific regulatory documentation. Many Pakistani instrument manufacturers can supply instruments but struggle to provide documentation required for formal medical device registration in regulated markets. Pintech provides:
Tell us your country and instrument requirements. We respond with market-specific pricing, regulatory documentation details and shipping information within 24 hours.