REGULATORY AFFAIRS

Experienced Regulatory Affairs Team Support for Regulatory Accreditation in Europe & Asia
FDA 510(k) Clearance for SHL Products Compliance to Medical Device cGMP’s
Support for NDA & BLA Filing with US FDA Established Medical Device Reporting System

COMPLIANCE

SHL complies with extensive regulations regarding safety, efficacy and overall quality of our products, which have 510(k) clearance according to the Federal Food, Drug and Cosmetic Act.

SHL is also subject to government regulations, most notably from the Food and Drug Administration (FDA) in the United States. Typically, it is our pharmaceutical partners who undertake the application of regulatory approval for their finished injection devices, however, we understand that this process is lengthy, expensive, and subject to unanticipated delays. Therefore, we offer our customers full support during the application process via a team of regulatory experts who are familiar with the stringent accreditation processes in various countries.

REGULATORY APPROVAL

We have successfully assisted customers in obtaining regulatory approval in North America, Europe and Asia. For our US customers, we will support New Drug Applications (NDA) or Biologic License Applications (BLA) with the FDA as our established master files support the approval process. SHL is also recognized by the Japanese Minister of Health, Labor, and Welfare (MHLW) as an Accredited Foreign Manufacturer (AFM) and our manufacturing facilities comply with Ministerial Ordinance No. 169.

SHL complies with all applicable general controls. This includes establishment registration, device listing, post-market surveillance, medical device reporting and compliance with the FDA’s Quality System Regulations (21CFR 820).