Global Medical Device Export & OEM Solutions
Exporting ISO 13485 & CE-certified single-use disposable medical devices to over 52 countries worldwide with complete regulatory support and private label manufacturing.
Three Decades of Global Healthcare Supply Chain Excellence
At Angiplast Private Limited, international trade is the cornerstone of our manufacturing strategy. Over 80% of our total production is exported across six continents, serving government health ministries, regional medical device distributors, hospital consortia, and international pharmaceutical brand owners.
Since our establishment in 1994 in Ahmedabad, India, we have engineered an export infrastructure focused on stringent international quality compliance, batch-to-batch traceability, streamlined documentation, and container loading efficiency. Whether supplying high-volume tender orders or specialized OEM private-label portfolios, Angiplast delivers consistent product safety and compliance to global buyers.
- ISO 13485:2016 Certified Quality Management System
- CE Marked Product Portfolios for European and International Markets
- US FDA 510(k) Cleared Lines for Select Medical Disposables
- Clean Room Class 10,000 Assembly & Captive ETO Sterilisation Plant
- Active Regulatory Support for Importer Product Registration
Supplying Healthcare Networks Across Global Markets
Our dedicated international trade desk understands region-specific regulatory standards, language requirements, and logistics paperwork to guarantee smooth customs release and local market compliance.
Latin America & Caribbean
Providing custom Spanish & Portuguese packaging, ANVISA-oriented technical documentation, and bulk supply for tender operations across Brazil, Mexico, Colombia, and Peru.
Europe & CIS Region
CE Technical files, multilingual instructions for use (IFU), and Russian/English artwork support tailored for healthcare importers and private label brand owners.
Middle East & GCC
Established relationships with hospital purchasing groups, MOH tender suppliers, and GCC registration documentation packs for UAE, Saudi Arabia, and Oman.
Africa Region
Supporting national health programs, NGO tenders, and regional importers with high-volume infusion, urology, and surgical disposables in durable export packaging.
South & South-East Asia
High-capacity manufacturing and short lead times for high-demand consumables including IV cannulas, infusion sets, and dialysis blood tubing lines.
North America & Global OEM
Contract CDMO manufacturing for international medical companies requiring audited clean room production and US FDA 510(k) registered device manufacturing.
Complete Technical Dossiers & Tender Registration Assistance
We work directly with international regulatory teams and local importers to accelerate market approval and tender submissions.
Quality System
Certified Quality Management System covering full production, risk management, and environmental monitoring.
European Conformity
Products conform to applicable European Medical Device Directives and Regulations with complete technical files.
FSC & Legalization
Issuance of notarized, apostilled, and chamber-authenticated Free Sale Certificates to simplify authority registration.
STED Documentation
Provision of raw material safety data, biocompatibility reports, shelf-life stability tests, and validation data.
Export Packaging, OEM Labeling & Freight Management
International shipping demands high packaging integrity and efficient space utilization. Every device leaving our plant is packed in medical-grade sterile pouches and heavy-duty corrugated export cartons designed to withstand long transit cycles.
OEM & Private Label Customization
We provide comprehensive private label contract manufacturing. Our in-house design team produces customized pouch film artwork, outer carton graphics, barcoding (UDI compliant), and multi-language user manuals to match your local market branding.
Container Load Optimization
Our logistics team optimizes pallet loading and carton dimensions for 20ft and 40ft High Cube containers, minimizing freight cost per unit for sea freight (FOB, CIF, CFR) and expedited air cargo shipments.
Frequently Asked Questions for International Importers
Key information for healthcare distributors, buyers, and medical brand managers looking to source from Angiplast.
Angiplast operates under an ISO 13485 certified quality management system. Our product lines carry CE certification, and selected device families hold US FDA 510(k) clearance. We also issue Free Sale Certificates, Certificates of Origin, and complete product technical files for local ministry registrations.
MOQs depend on whether standard Angiplast brand packaging or custom OEM/private label packaging is selected. For standard items, MOQs start from standard master carton quantities. For private label orders, MOQs are aligned with standard production lot sizes per SKU.
We provide full technical documentation support including STED dossiers, sterilisation validation data, biocompatibility test results, physical/mechanical test reports, manufacturing process flowcharts, and certified Free Sale Certificates.
We regularly handle FOB, CIF, CFR, and EXW shipping terms. Payment options include Irrevocable Commercial Letter of Credit (L/C at sight) and Wire Transfer (T/T), structured to support long-term distribution partnerships.
Partner with an Experienced Global Medical Exporter
Request technical specifications, product catalogues, or request an export quotation for your market requirements.