Medical Device Registration

Medical Device Registration

Medical Device Registration

Allurmed provides comprehensive regulatory support for medical device registration and market access to manufacturers, authorised representatives, importers and distributors.

We support the entire process, including preliminary product assessment, medical device classification, technical documentation review, registration dossier preparation, labelling compliance, regulatory submission and post-registration support.

Our medical device regulatory services

  • medical device classification;

  • determination of Class I, IIa, IIb and III risk categories;

  • development of a product-specific registration strategy;

  • technical documentation and registration dossier review;

  • assessment of ISO 13485, CE and conformity documentation;

  • review of risk management documentation;

  • clinical evaluation and performance evidence review;

  • assessment of sterilisation, biological safety and testing documents;

  • label, packaging and instructions-for-use compliance;

  • professional medical and technical translation;

  • preparation of responses to regulatory authority questions;

  • management of post-registration changes and renewals;

  • post-market surveillance and medical device vigilance support.

Product categories we support

Allurmed provides regulatory support for:

  • medical devices and equipment;

  • dental devices and implants;

  • surgical instruments;

  • orthopaedic implants and prosthetic components;

  • diagnostic and laboratory devices;

  • in vitro diagnostic products;

  • sterile single-use medical devices;

  • catheters, cannulas and injection systems;

  • medical device software;

  • hospital and laboratory equipment.

Why Allurmed?

Successful medical device registration depends on correct classification, justified risk categorisation and consistent technical documentation.

Allurmed develops an individual regulatory strategy for each product, identifies dossier deficiencies before submission and coordinates communication between the manufacturer and the competent authority.

Contact Allurmed for medical device registration, technical dossier assessment and professional market-access support.