Post-Registration Activities
After approval, the registration has to keep up with the product: changes, revalidations, certificates and the history of every filing, with each product’s expiry calendar.
- Company stage
- Sustain
The registration lifecycle.
Changes to the product, the manufacturer or the company may require a filing. We map what must be reported, and when.
Changes
Filing of changes to registrations or notifications: formula, manufacturer, presentation, labelling or company data.
- Change assessment
- Filing
- Dossier update
Revalidations
Planning and filing of revalidations on time, with an updated dossier.
- Expiry calendar
- Registration revalidation
Certificates
Registration certificates and export certificates: Certificates of Free Sale for cosmetics and sanitizing products; notification or registration certificates for medical devices.
- Registration certificate
- Certificate of Free Sale
Technical requests
Analysis of and answers to agency requests in post-registration filings.
- Request analysis
- Technical answer
Technovigilance
Support for technovigilance management of medical devices once they reach the market.
- Reporting routine
- Liaison with ANVISA
Other services for this stage.
- Regulatory ManagementSustainDeadlines, renewals and ancillary obligations for licences and registrations, followed continuously.
- Quality ManagementSustainQualification and audit of suppliers and partners, with the records of each assessment.
- In-Company TrainingSustainTailored programmes on quality, operational routines and training policy.
Common questions before you start.
When do I need to file a post-registration change?
Whenever anything approved changes: formula or components, manufacturer, manufacturing site, labelling, packaging, shelf life or the holder’s company name. Each type of change has its own filing subject and documents, and some require approval before implementation.
How far in advance should I apply for revalidation?
It depends on the product. For medical devices, for example, the registration is valid for ten years and renewal is requested between twelve and six months before expiry; device notifications do not expire. We keep each product’s calendar so the filing goes in within the right window.
What is technovigilance and who is responsible?
It is the monitoring of adverse events and technical complaints involving medical devices once they are on the market. The responsibility lies with the registration or notification holder, which must keep procedures in place and notify ANVISA.
Last updated: October 2026.
Registrations expiring or product changes ahead?
We review the authorized portfolio and build the calendar of changes and revalidations.