Question 1

Which quality certifications does Mediplus hold for medical disposables?

Accepted Answer

Our Vatva, Ahmedabad plant operates a quality management system certified to ISO 13485 and ISO 9001, with CE marked product families under the EU MDR pathway and products manufactured in ISO Class 7/8 clean rooms. Batch-wise documentation, sterilisation validation records and Certificates of Analysis accompany every export consignment.

Question 2

Do you support OEM and private-label medical disposable manufacturing?

Accepted Answer

Yes. We produce private-label infusion sets, catheters, dialysis lines and anaesthesia consumables with buyer-specified artwork, multilingual IFUs, carton dimensions, barcodes and UDI data. Artwork proofing usually takes 5–7 working days before pilot production.

Question 3

What is the minimum order quantity and lead time for export orders?

Accepted Answer

Standard catalogue items typically start at one pallet per SKU, while private-label programmes begin at a single 20-ft container mix. Regular items ship in 3–4 weeks; new OEM tooling or registration-linked items take 6–8 weeks from artwork approval.

Question 4

How are the products sterilised and how is sterility validated?

Accepted Answer

Single-use devices are sterilised by ethylene oxide (EO) or gamma irradiation as per product design. Each sterilisation cycle is released against biological and chemical indicators, EO residue limits and bioburden testing, with validation dossiers available to registration holders and notified bodies.

Question 5

Can Mediplus provide documents for product registration in our country?

Accepted Answer

Our regulatory team supplies Free Sale Certificates, ISO 13485 and CE certificates, technical files, biocompatibility summaries, stability data and legalised documents required by Ministries of Health across the Middle East, Africa, Latin America, CIS and Southeast Asia.

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