Changes to a registered device require an amendment application naming one of fourteen enumerated changeable items
New findings on the quality, safety or efficacy of a registered medical device are notified by filing an amendment application, and the rulebook enumerates fourteen changeable items: the manufacturer's name or address; the applicant's name or address; the applicant; the device name; the manufacturer of input components; a new place of manufacture for part or all of the production process named in the certificate; the finished-product testing procedure (standards and methods); the appearance and manner of outer or inner labelling; the shape, packaging or dimensions of the device; the class; the shelf life; the storage conditions; the manner of dispensing or selling; and the place of dispensing or selling. Where the documentation filed under Article 7 or Article 8 at first registration is unchanged, the applicant may refer to it instead of resubmitting.
- The change fee is 40 per cent of the registration fee for a variation, and 10 EUR for a minor variation notified as part of the technological process (Article 11 as replaced by the 86/25 amendment).
- The amendment application is a cover letter, the completed amendment form for the class, documentation on the change sufficient for its assessment, and proof of fee payment (Article 14).
Effective from 2010-11-30
Macedonian. Articles 12 to 16 of the 151/10 rulebook govern changes; Article 13 enumerates the changeable items and Article 16 allows reference back to the original documentation where unchanged. The rulebook is a 2010 sub-legal act still published by MALMED as the applicable device registration rulebook.