This procedure involves changing the data of a previously registered medicinal product or medical device. The changes made must not reduce the safety and quality of the product.
Changes are classified into:
- Type I changes that do not require a new registration, changes concerning amendments to the content of the registration dossier, in accordance with Appendix 10 to the Rules;
- Type II changes requiring a new registration: changes not specified in Appendix 10 to the Rules are related to Type II changes and require a new registration.
Types of changes made:
- Change of information about the manufacturer/production site of the medical device
- Change of information about the authorized representative, including information about the reorganization of the legal entity, about the change of its name, change of the last name, first name, patronymic (if any) of the address of the place of residence of the individual entrepreneur
- Change of the name of the medical device
- Change of the composition of accessories and (or) components and (or) consumables, update (installation of a new version) of the software
- Change of indications for use; area of application; contraindications; side effects
- Change of manufacturers of components, accessories, consumables
- Increase/decrease in the shelf life of the medical device
- Change of storage conditions
- Change in the quality control procedure for the finished product of the medical device
- Change of the packaging of the medical device: primary packaging of the medical device; secondary and/or group packaging, transport, intermediate
- Change of impressions, primer or other markings, stamps and inscriptions, including the addition or change of paint used to label the medical device.
