International Manufacturer Compliance
One System, many sites. A US headquartered multi-national implant manufacturer had been marketing in Taiwan for more than ten years and had obtained multiple product approvals based on US FDA approvals.
Rapid expansion over that period spanned had enlarged operations to more than 20 separate global manufacturing sites controlled by a single quality system. Taiwan FDA normally requires separate quality certification (Taiwan QSD) for each individual facility, presenting a logistical and regulatory nightmare for such highly decentralised operations.
Brandwood Biomedical were able to work closely with the manufacturer and Taiwan FDA (including meeting with senior officials in Taipei) to resolve a path forward to demonstrate effective single system QA control and achieve a single QSD certification covering all manufacturing facilities.
This saved both manufacturer and regulator countless hours and administrative overhead from the need to track and maintain a large number of separate certifications and provided complete flexibility to adjust manufacturing operations without need for re-certifications.
Need help with international manufacturer certifications – struggling to resolve conflicting requirements of different jurisdictions? We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.