Notifying Design and Characteristic Changes Under Article 6.3.3

1. Key takeaways

Article 6.3.3 (c) of RTS 11.03.02:21 requires supporting documents to be submitted for two categories of event: changes made by the manufacturer to documents contained in the registration file, and any change to the design or characteristics of the device that directly or indirectly affects its performance, where the change occurs while the registration is in force. Article 6.3.3 (d) goes further and requires that all changes occurring after authorisation be recorded in the file at the time renewal is sought. Article 6.3.3 (a) adds a precondition: the registration must be valid and the annual fee must be paid.

• The word indirectly widens the scope of notifiable change well beyond alterations to the product itself.
• Notification under (c) and the consolidated record under (d) are two sides of one duty: changes are filed as they happen and reviewed in full at renewal.
• Change fees are charged per item and per affected code, which is a different logic from the tier pricing applied to registration.
• An unpaid annual fee blocks changes entirely, so a trivial arrears balance can stall an urgent amendment.
• The technical director has a parallel reporting duty for process and facility changes affecting quality.

2. Legal basis

The obligations sit in the post-registration provisions of the device regulation, supported by the requirement that file documents remain valid and by the fee schedule for changes. The table below sets out the four provisions that shape a change programme, together with the relevant charges. Read together, they show that a change is assessed twice: once when it happens, and again when the registration comes up for renewal, with a different question asked on each occasion.

3. Expert insights

The first point is that the word indirectly stretches the notifiable perimeter further than most companies assume. Article 6.3.3 (c) uses directa o indirectamente, directly or indirectly. Notification is therefore not confined to a change in product design. Replacing a raw material supplier, altering the sterilisation method, updating a software version, or relocating a manufacturing site are all changes in which the model number stays the same, yet each falls inside the perimeter if it may indirectly affect performance.

The second point is that item (d) turns change management into a ledger that is audited at renewal. The provision requires all changes made after registration to be recorded in the file when renewal is sought. This makes the immediate notification under (c) and the consolidated record under (d) two sides of a single duty: changes may be handled in batches during the term, but at renewal the authority sees the complete list. A change that was never notified has nowhere to hide at that point, which is why this is the most frequently underestimated compliance risk in the post-market phase.

The third point is that changes are priced per item while registration is priced per code, and the two logics do not converge. Article 3.2.1 of the Tarifario charges a base fee of USD 48.00 for a change to a code or model name or description, plus USD 0.60 for each affected code or model. Article 3.2.3 charges a flat USD 48.00 for other post-registration changes. A single renaming exercise covering fifty models therefore costs USD 48.00 plus USD 30.00, or USD 78.00, rather than being recalculated against the registration tier. That is a materially different arithmetic from the renewal fee.

The fourth point is that the precondition in item (a) makes arrears a global block on change. A change can only be processed while the registration is valid and the annual fee is paid. A company wishing to correct a model description or replace a professional responsible must first clear the annual fee. Scheduling changes away from the fee payment date is the practical way to avoid a stall that has nothing to do with the substance of the amendment.

4. Practical recommendations

• Build a change triage list that explicitly captures changes with an indirect effect on performance, rather than only product redesigns.
• Notify each change as it occurs and archive the notification, so that a complete change ledger can be produced at renewal.
• Estimate change fees as the base fee plus the number of affected models multiplied by USD 0.60, and keep that calculation separate from the renewal tier fee.
• Schedule changes away from the annual fee payment date, so that Article 6.3.3 (a) does not block the filing.
• Have the technical director report process and facility changes affecting quality in parallel, under Article 6.2.4.1 (e).
• Write the response time for change notifications into the service agreement with the registration holder.

5. Verification checklist

• □ The change triage list includes indirect-effect items
• □ Each change is notified promptly and archived
• □ Change fees are calculated as base fee plus affected model count
• □ Change scheduling avoids the annual fee payment date
• □ The technical director’s parallel change report is submitted
• □ Change response times are written into the service agreement

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Salvadoran market. Our team manages Ministry of Health (MINSAL) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com