CONFORMITY ASSESSMENT OF MEDICAL DEVICE

Conformity assessment by audit of legal manufacturer

This procedure involves the arrival of the auditors – the representatives of Ukrainian conformity assessment authority – to the manufacturer. The object of the audit is the quality management system of the legal manufacturer. The number of auditors and audit days is calculated individually for each company and depends on the number of staff members, number of production sites and a range of other factors.

Technical documentation on medical products is submitted to the authority, as well as documentation on the manufacturer’s quality management system. Each authority has its own requirements for the submitted documentation, its volume, availability of translations and legalization of documentation. These nuances should be considered before preparation and submission of technical documentation.

After submitting of documentation and applying for the procedure, the authority executes works of stage 1.

Before the arrival of auditor or group of auditors, the date of the audit is agreed with the manufacturer, alongside with the group and execution plan.

In case of comments on the audit results, certain time is provided for their elimination, submission of additional documentation.

As a result of completed procedure, a certificate of conformity assessment will be issued, which will be valid for 5 years, on the basis of which the manufacturer or its authorized representative (in case of availability of the relevant rights) issues a declaration of conformity assessment.

Archimedes company possesses necessary experience and knowledge to support the conformity assessment procedure by audit and is ready to offer you:

  • a full range of counselling on issues related to legalization of medical products on Ukrainian market;
  • assistance in collection, localization and preparation of Technical Documentation for submission to the conformity assessment authority;
  • appointment of an authorized representative;
  • assistance in choosing conformity assessment authority and communication with the authority throughout the procedure;
  • organization of audit, coordination of dates, audit plan;
  • elimination of comments, preparation of a draft of the declaration of conformity assessment, certificate approval and receiving of the original;

In addition, a plan for carrying out supervisory audits will be agreed with the manufacturer. The frequency of supervisions is once a year.

Supervisory audits are carried out by the conformity assessment authority, as a rule by a single auditor, duration – one day.

During the supervisory audit, the manufacturer and its Authorized Representative have an opportunity to make changes to the current certificate, namely:

  • to change the name of the products;
  • to expand/reduce the list of the products;
  • to change name or address of the legal manufacturer;
  • to expand/change the list of production sites;

Etc.

Such changes may affect duration of the supervisory audit.

Also, there are changes that do not require carrying out an audit.

 

You can get more detailed consultation by writing us a short request or by calling the number below.