Compliance
SUNVERA is not a manufacturer and does not issue product certificates. For healthcare shipments, we request the documents the destination country requires from the manufacturer and the supply chain, and before shipment we check that they are complete and consistent with each other. This page summarises the regulations and the document set commonly required for healthcare products.
Governs the placing of medical devices on the market in the European Union. Depending on the device class, it requires a Notified Body assessment, a declaration of conformity and CE marking. Many buyers outside the EU also ask for MDR documents as a reference.
Covers in vitro diagnostic devices such as reagents, kits, calibrators and analysers. For laboratory products, the declaration of conformity and, where required, the Notified Body certificate are requested under this regulation. Transition periods vary by device class.
The quality management system standard covering the manufacturer's design, production and traceability processes (ISO 13485:2016). We ask the manufacturer for its valid certificate and the scope of that certificate.
Shows how the manufacturer identifies and reduces risks over the device's life cycle. Some buyers and tender specifications ask for a summary of the risk management file.
The storage and transport of medicinal products for human use follow EU guideline 2013/C 343/01 and WHO guidance. Temperature control, records and traceability are expected at every link of the chain.
Shows that the manufacturer of a medicinal product or active pharmaceutical ingredient works under production conditions inspected by the competent authority. The manufacturer's GMP certificate is one of the core documents for pharmaceutical shipments.
A system that identifies the device and its production unit on the label. It has become mandatory in the EU under MDR and IVDR and in the US under FDA rules; buyers increasingly ask about the UDI carrier on the label.
Issued under the WHO Certification Scheme by the authority of the country where the product is manufactured or exported. Many countries require a CPP for marketing authorisation applications; the application itself is made by the buyer or the local authorisation holder.
Document set
The document in which the manufacturer declares, under its own responsibility, that the product complies with the applicable regulation. We check that model and catalogue numbers match the order list.
The CE certificate issued by a Notified Body for medical devices whose class requires it. Validity date and scope are checked.
The manufacturer's quality management system certificate. We review the issuing body, the product groups in scope and the validity period.
An official document showing that the product is freely sold in its country of manufacture. Many countries require it for registration applications; it often needs an apostille or consular legalisation.
Shows test results per lot. An integral part of shipments of pharmaceuticals, active pharmaceutical ingredients, reagents and sterile products.
For sterile products, a summary of the method used (ISO 11135 for ethylene oxide, ISO 11137 for radiation, ISO 17665 for steam) and the lot sterilisation record.
Label samples and instructions for use are checked against the language requirements of the destination country. Manufacturer, lot and expiry details on the label must match the documents.
For medicines, the manufacturer's GMP certificate and, where needed, a CPP; for products with chemical content, the safety data sheet (SDS, formerly MSDS).
Responsibilities
Responsible for the design, manufacture, conformity assessment, labelling and post-market surveillance of the product. The manufacturer prepares the declaration of conformity and the technical documentation.
Specifies the product, finds a suitable manufacturer, requests the documents from the manufacturer and checks consistency between the order, the buyer's requirements and the documents. Coordinates the contract, payment and shipment. Does not issue product certificates and does not hold marketing authorisations in the destination country.
Marketing authorisation or registration of the product in the destination country, import permits and, where required, post-market reporting are the responsibility of the buyer or the local authorised representative. We plan the documents needed for this process together.
This page is for general information and does not replace regulatory advice. We recommend confirming the rules that apply to your product with the competent authority of the destination country and with your regulatory adviser.
Share the product, model or specification, quantity, destination country and required documents. We will work out the sourcing options and shipment plan with you.
