Various medical devices and products

Summary

The tender concerns various medical devices and products divided into 61 lots. The exact quantities per lot are in the technical specifications. The contract is open procedure for supplies, with an estimated value of RON 50,868,300. Bidders must be legally registered for the relevant activity, and the same applies to subcontractors for their part of the contract. The bidder must submit a single procurement document and, if requested, the winning bidder must provide supporting registration documents. The bidder must meet lot-specific financial capacity requirements based on the average annual turnover for the last 3 financial years. The required turnover equals at least the estimated value of the largest subsequent contract for the chosen lot, ranging from RON 2,700 to RON 6,000,000 depending on the lot. The bidder must also prove similar supply experience from the last 3 years, again at a lot-specific minimum value ranging from RON 2,700 to RON 6,000,000. The procurement document must include contract number and date, contract type, value, beneficiary, and receipt details. A valid quality management certificate ISO 9001 or ISO 13485, or equivalent, is required. Some lots also require sector-specific authorisations, such as medical device import/distribution authorisation and, where relevant, radiological safety authorisation. Bidders, subcontractors and supporting third parties must not fall under the listed exclusion grounds. The notice also includes EU restrictions on medical devices and goods originating in China: Chinese-origin goods may not exceed 50% of the total contract value.