Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, FDA Registered, Supplier to Medical Manufacturers
Markets Supplied: Worldwide
in 1996 and located in the Republic of the Seychelles’ International Trade Zone
Sector (SITZ), Chelle Medical Limited provides niche contract manufacturing
solutions for medical device manufacturers.
We are a subsidiary of Venner Capital SA. Our registered office is
located at Le Rocher, Mahe, Seychelles, the Seychelles’ largest island.
Our rigorous focus on quality compliance combined with low staff turnover and competitive cost structure make Chelle an ideal partner for light manufacturing.
Chelle Medical provides its customers with niche medical device contract manufacturing services including:
- Light electromechanical/mechanical assembly
- Silicon product assembly
- Functional testing
- Supply chain management/parts procurement
- Logistics management
- EN ISO 13485:2016 registered
- Compliant with US FDA 21 CFR Part 820
- Compliant with Japan MHLW Ordinance No 169
- Certified by SGS (Singapore)
- Laryngeal mask airway
- Video laryngoscopes
- Tracheal seal monitors
- Orthopedic screws
- PainCare infusion pumps
- Class 8 cleanrooms
- ESD protected areas (where required)
- Laser marking capabilities for traceability
Chelle’s robust quality systems, production infrastructure and experienced team position it well to support three primary contract manufacturing solutions:
Chelle Medical Flexible Support
Chelle regularly supports customers who need additional light manufacturing capacity or wish to offload light assembly projects that don’t fit their in-house manufacturing model. Our production team is experienced with silicon, single use device and light electromechanical assembly. Our comprehensive support capabilities include supply chain management of our customers’ approved suppliers and purchasing of required materials. Printed circuit board assemblies (PCBAs) and precision engineered parts are normally sourced from customer-designated third-party suppliers for electromechanical assembly operations.
Chelle Medical Remanufacturing/Refurbishment Support
Chelle Medical’s Seychelles location enables us to offer the right mix of superior quality and competitive cost for projects designed to extend the useable life of older technology products via resale to developing markets. The Seychelles participation in African trade agreements such as COMESA and SADC combined with its International Trade Zone Sector (SITZ) simplify market entry and may eliminate or mitigate tariffs. Chelle Medical can support projects requiring cleaning, testing, repairing, refurbishing, remanufacturing and/or repackaging older technology medical products. Our superior quality focus and certifications help ensure that the products we refurbish or remanufacture meet end market regulatory requirements.
Chelle Medical Emerging Market Support
Chelle’s geographic proximity to Africa and the Middle East along with the SITZ and preferential trade agreements such as COMESA and SADC, make it a good option for light assembly of medical devices destined for countries in this region. Our clean room infrastructure and availability of experienced assemblers ensures flexibility in range of products that can be assembled. Our team can also support the logistics side of the equation with packaging, customs documentation support and shipping to end market.
The Seychelles – Do Business in a Tropical Paradise
Doing business with Chelle Medical combines the advantages of preferential trade mechanisms with an island paradise. English and French are widely spoken and business is conducted in English. Chelle is located in the Seychelles International Trade Zone Sector (SITZ). The Seychelles’ bilateral trade agreements include South Africa, Switzerland, the European Union, Thailand, Japan, Canada and the U.S. The Seychelles participation in African trade agreements such as COMESA and SADC combined with the SITZ simplify logistics and market entry and may eliminate or mitigate tariffs. The Seychelles’ focus on tourism ensures excellent transportation systems and superior accommodations, making it enjoyable environment once business is concluded.
Benefits associated with manufacturing in the SITZ include:
- 0% customs duty
- 0% VAT for capital equipment, raw materials, office furniture and equipment
- 0% VAT on intermediate and final products
- Exempt from ITZ Work Permit for foreign workers
- 100% foreign ownership permissible
- Ability to import foreign workers for skills absent in Seychelles
- Exemption from stamp duty except for instrument for freehold properties
- Exemption from immovable property tax.
For more information contact Chelle Medical Ltd