International Procurement Intelligence & FAQs

Manshav Impex (part of the Manshav Global Group, founded in 2019 by Sharmil Mangukiya) is an Indian medical device manufacturer, OEM private-label supplier, and global exporter. We provide direct access to 120+ ISO 13485 and WHO-GMP certified cleanroom manufacturing facilities, supplying surgical consumables, orthopedic implants, ICU hospital furniture, diagnostic devices, and PPE to 48+ countries across Africa, Latin America, Oceania, Middle East, and Europe.

Our product portfolio complies with ISO 13485:2016 (Medical Devices QMS), CE Marking under EU MDR 2017/745, WHO-GMP, and US FDA Establishment Registration. We also maintain full documentation and dossier alignment for regional health authorities including Australia TGA (ARTG inclusion), Brazil ANVISA, Mexico COFEPRIS, Colombia INVIMA, Nigeria NAFDAC, Kenya PPB, Tanzania TMDA, and South Africa SAHPRA.

We provide complete export documentation within 24 hours of vessel departure or airway bill issuance. Standard sets include the Commercial Invoice, Packing List, Certificate of Origin (COO / Chamber of Commerce legalised), Certificate of Analysis (CoA), Batch Sterilization Validation Certificates (EO / Gamma), and Bill of Lading (B/L) / Air Waybill (AWB).

Our sterile latex surgical gloves are manufactured to an ultra-strict Acceptable Quality Limit of AQL 1.0 (significantly higher barrier integrity than standard AQL 1.5 or AQL 2.5 examination gloves). They feature an extended 280 mm minimum beaded cuff, curved anatomic finger molds to prevent surgeon fatigue, micro-textured grip, low protein content (<50 µg/g), and 100% individual water-leak barrier testing per EN 455 Parts 1–4 and ASTM D3577.

We manufacture surgical blades in premium Carbon Steel (Grade T10 / 1095) and Stainless Steel (AISI 420), conforming to BS 2982 and ISO 7740. Sizes 10, 11, 12, and 15 fit standard No. 3 scalpel handles; sizes 18, 20, 21, 22, 23, and 24 fit No. 4 handles. All blades undergo Gamma Radiation sterilization (25 kGy) with a 5-year shelf life in VCI anti-rust individual foil packets.

Our disposable syringes (1ml to 50ml, 2-part and 3-part, Luer Slip and Luer Lock) conform to ISO 7886-1 with high-transparency medical-grade polypropylene barrels, indelible black graduations, and latex-free gaskets. Our IV Cannulas (14G to 26G) feature FEP/PTFE radiopaque catheters, dual-tapered tips, injection ports with silicone non-return valves, and color-coded wings conforming to ISO 10555-1.

Our surgical gowns are fabricated from 35–55 gsm SMS/SMMS non-woven fabric with ultrasonic welded seams, meeting EN 13795 and AAMI PB70 Level 3 / Level 4 critical-zone fluid resistance. Our 3-ply surgical masks feature 25 gsm meltblown filtration (BFE ≥ 98%, PFE ≥ 98%, splash-resistant Type IIR per EN 14683).

Yes. Over 60% of our global export volume is custom-branded OEM / Private Label. We offer complete customization including custom brand naming, barcode generation (EAN-13, GS1-128), multi-lingual inner box and pouch printing (English, French, Spanish, Portuguese, Arabic), and customized master shipping cartons.

MOQs for private-label production start from 50,000 pairs for surgical gloves, 10,000 units for surgical blades, 100,000 units for syringes, and 5,000 units for surgical gowns. Production lead times average 14–25 calendar days following client artwork sign-off.

Yes. We supply physical sample kits (with batch certificates and technical data sheets) for clinical evaluations, hospital trial committees, and distributor registration. Sample courier costs are fully credited against your first commercial container order.

We ship FOB (Mundra Port, Nhava Sheva / JNPT, Mumbai Air Cargo), CIF, CFR, DDP, and EXW. Payment terms include advance T/T wire transfer and Irrevocable Letter of Credit (L/C at sight) from prime international banks. Mixed-container consolidations (FCL / LCL) are fully supported.

Direct sea freight transit from Mundra / Nhava Sheva is approximately: Middle East (7–14 days), East Africa (10–18 days), North Africa (12–22 days), West & Southern Africa (18–32 days), Latin America (25–38 days), and Australia (18–26 days).

We provide complete technical dossiers including Free Sale Certificates (FSC), Certificate of Pharmaceutical Product (COPP), GMP Audit Certificates, ISO 13485 QMS Certificates, sterilization validation test reports, biocompatibility summaries (ISO 10993), and plant audit documentation tailored for ministry tenders (such as NAFDAC Nigeria, PPB Kenya, TMDA Tanzania, SAHPRA South Africa, ANVISA Brazil, and TGA Australia).