In the sensitive healthcare industry, how do we consistently uphold the credibility of Steroplast in numerous countries where laws and compliance differ so widely? Understanding the complexities of international regulations is the key to the dependable service customers turn to for peace of mind.
But it’s not just regulatory compliance that makes a good export service. We’re committed to upholding our excellent reputation with our own stringent quality controls at every step of the export journey to keep you informed.
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25% of our turnover comes from medical equipment exports to 57 countries worldwide.
British-made products are the best quality you can find. As a leading healthcare brand and pharmaceutical exporters UK businesses trust, we’re the best of the best.
In alignment with our commitment to safety and ethical business practices, Steroplast Healthcare has partnered with TINYg, a global non-profit organisation devoted to the prevention of terrorism and enhancing security. This collaboration underscores our dedication to contributing positively to community safety and well-being.
We operate in full accordance with the requirements of BS EN ISO 13485:2012 supported by the Medical Device Directive (M.D.D.) 93/42/EEC and The Wholesale Dealers Authorisation Licence. Through our authorisations and licenses for wholesale and distribution activities, we bring clients the level of compliance and quality management they need to export medical supplies successfully.
Our products are registered with the Medicines and Healthcare Products Regulatory Agency, and this third-party assurance from auditing, inspection, and continuous feedback is what gives our clients and us peace of mind that we’re always working ethically, optimally, and with complete compliance.
Find out more about our quality assurances and ethical policies.
We deliver in 1–2 working days for parcels and next working day for pallets, with tracking at every stage.
As our main export region, we’re acutely familiar with all key regulations you must meet for healthcare, pharmaceutical, and medical equipment exports to the EU.
Concerning the safety and performance of medical devices, the MDR sets out the standards that products need to meet to be sold in the EU. Risk classification, clinical evaluation, unique device identification, notified bodies, and post-market surveillance are just some of the considerations that need to be met.
All Steroplast products are made to meet the MDR, and we ensure everything we export will pass the relevant checks.
Any in-vitro diagnostic devices must meet the IVDR to ensure they are of the right standard of safety, performance, reliability, and general operation standards. Like the MDR, in-vitro products must meet various requirements of evidence-based testing, traceability, and classification to be imported to EU countries under the IVDR.
Specifically concerning the export of pharmaceutical products, the EMA oversees the evaluation, supervision, and regulation of medicinal products sold in the EU. Clinical development, quality assurance and good manufacturing practices, pharmacovigilance, and regulatory submissions and procedures must be considered and met.Are you a pharmaceutical export business? Steroplast Healthcare is fully licenced to sell POM, OTC, and GSL pharmaceuticals and export them overseas. Take a look at our pharmaceutical range.
Designed to protect the privacy and personal data of individuals in the EU and regulate data processing by organisations, GDPR must be recognised in all aspects of exporting to the EU. This is something that comes as second nature at Steroplast Healthcare.
Designed to protect the privacy and personal data of individuals in the EU and regulate data processing by organisations, GDPR must be recognised in all aspects of exporting to the EU. This is something that comes as second nature at Steroplast Healthcare.
A range of family-friendly first aid kits that can display your company branding.
We’re always looking for opportunities to expand the reach of our innovative products. If you’re a US distributor interested in getting FDA approval to supply our products in the US, we’re ready to work with you.
Our export team is poised to help you prepare to import Steroplast products and will navigate the complex laws and compliances of the US healthcare market to help you uphold your brand name.
Outside of the EU and US, local laws vary widely. It’s down to our attention to detail and 25 years of industry experience to ensure we’re following all the necessary regulations wherever we export to.
Oftentimes a country will require registration and approval of any medical devices, pharmaceuticals, supplies, or equipment that enter the country. We ensure you’re prepared for exporting medical devices to any country.
Taxes, tariffs, and duties vary per country and must be considered when preparing a medical supplies export. Our export team will take all regional trade agreements into consideration, so there won’t be any surprises.
General laws that govern the import and export of medical supplies need to be anticipated, and our team are prepared to incorporate them into your export.
Numerous distributor benefits when you partner with us, including:
If you would like more information about our selection of products, please complete the form, and a member of our team will be in touch to discuss how we can help.
Tel: 0161 902 3030
Email: enquiries@steroplast.co.uk
Fax: 0161 902 3040