UKCA Marking for Medical Devices in Algeria | MHRA & UKRP Support – Operon Strategist

 Operon Strategist provides expert consulting for UKCA marking of medical devices in Algeria, ensuring compliance with UK Medical Devices Regulations 2002 (UK MDR 2002). We assist Algerian manufacturers with MHRA registration, technical documentation, conformity assessments, and appointment of a UK Responsible Person (UKRP) for smooth access to the Great Britain market. Our services cover device classification, QMS implementation aligned with ISO 13485, and preparation of regulatory submissions through the MHRA’s DORS system. With the CE mark acceptance ending in June 2024, UKCA marking has become mandatory, making early compliance crucial for exporters. Operon Strategist helps Algerian medical device manufacturers fast-track approvals, avoid regulatory delays, and achieve successful market entry in the UK.



Read More

Comments

Popular posts from this blog

Quality Challenges in the Medical Device Industry: A Strategic Guide for Oman in 2025