Regulatory Compliance
Complete Confidence
The global healthcare infection control sector can be complicated by local/national rules and different interpretations of international standards. The in house Regulatory and Quality Team are dedicated to the ongoing compliance and quality of the site and all products that are manufactured by Topdental.
This ensures customers can not only register products with their national medical regulatory authority but can have complete confidence that expert hygiene and infection control advice and correct documentation can be provided to assist with this sometimes complicated process.
Regulatory Responsibilities
Keeping track of the ever-changing legislation in all global regions and implementing the necessary changes required for continued compliance.
Advising on legal and scientific restraints and requirements.
Collecting, collating, and evaluating scientific data.
Advising on labelling requirements.
Collating Technical Files.
Presenting registration documents to international health authorities necessary to obtain or maintain marketing authorisation for the products concerned.
Post-production activities such as complaint trending and post-market surveillance activities to ensure that any adverse events are appropriately reported.
Maintaining and improving the Quality Management System in line with the requirements of ISO13485:2016, to which Topdental is certified.
Brexit
One of the most recent Regulatory focuses has been the many changes that have occurred in and around Britain’s exit from the European Union.
This included the switch to a European Notified Body, and the transition to the new Medical Device Regulations or MDR (EU 2017/745) which Topdental are currently in the process of addressing.
Topdental is audited by SGS https://www.sgs.com/en
Biocidal Product Regulations
Topdental have an ongoing programme of activities to ensure that all relevant devices are compliant with the Biocides Regulations (EU) 528/2012.
The Biocidal Product Regulation (EU BPR, EC 528/2012) https://echa.europa.eu/regulations/biocidal-products-regulation/legislation was introduced in the EU in 2012 and transferred to UK law (as GB BPR) in 2021.
Biocidal products are any product that can be used to destroy or control harmful organisms. This includes all general surface disinfectant sprays and wipes and all hand disinfectant products that are used to control bacteria and viruses. Disinfectant products that are solely for use with medical devices are controlled by the Medical Device Regulations (MDR)
Biocide Transition Period
All biocidal products manufactured by Topdental are currently in the Transitional Registration Period and need to be registered individually in the UK and each EU country where the product is sold. Products are being registered in over 20 countries with half of the registrations already being completed.
The Transitional Registration Period lasts until the Active Substance in the product, either Ethanol or Quaternary Ammonium Compounds, are approved by the EU Commission or the HSE for the UK.
Approved Substances
Topdental only purchase Active Substances from suppliers that are listed on the Article 95/GB Article 95 lists. Once an Active Substance has been approved, Topdental apply for a Union Application allowing products to be sold in any country in the EU.
Topdental are a member of the British Chemicals Association https://bcaorg.com/
