Change Management: Notification of Minor Changes and Re-Approval of Major Changes (Article 15)

1. Key takeaways

Article 15 provides that a major change to a product requires re-approval. The decree itself gives no list of what counts as a major change, and the notification procedure for minor changes is left to the Executive Regulation, that is, Article 6(1)(h). Our judgment is that, in the absence of a list, the test for a major change should be whether the change touches any one of the eligibility conditions in Article 6(a)-(h): if it does, it is major and requires re-approval; if it does not, but affects the consistency of the registration information, it is handled by notification. The reason is that Article 15 and Article 6 share the same source; any change that alters an eligibility condition necessarily falls back within the review scope of Article 6, which EDE cannot replace with a notification procedure. On the trade-off, it is better to prepare the dossier for a major change than to let the entire registration lapse through a misjudgment.

• Article 15: major changes to a product require re-approval; the decree contains no list of major changes.
• The notification procedure for minor changes is reserved to the Executive Regulation under Article 6(1)(h).
• The test for a major change is whether the change touches any eligibility condition in Article 6(a)-(h), not the size of the modification.
• Failure to declare changes exposes the registration to revocation under Article 17 and to import permit revocation under Article 33.

2. Legal basis

The provisions governing change management, the eligibility conditions that serve as the yardstick, and the consequences of undeclared changes are set out in the table below.

3. Expert insights

Insight 1: The yardstick should return to Article 6(a)-(h), not the magnitude of the modification. Our professional judgment is that a change of manufacturing site (the GMP certificate in item f), a change of inner and outer packaging and instructions for use (item g), and a change of the applicant or MAH entity (item a) are all major changes. The reason is that these are precisely the eligibility conditions listed in Article 6; once altered, the foundation of the registration is swapped out. On the trade-off, do not conclude by the size of the modification but by whether an eligibility condition is touched; a seemingly small relocation of the manufacturing site directly constitutes a major change because the GMP certificate becomes invalid.

Insight 2: Where the minor change list is absent, replace industry practice with written confirmation. The judgment is that the Executive Regulation has not yet been issued, and the matters reserved under Article 6(h) cannot be inferred from experience in other markets. The reason is that item (h) expressly leaves other conditions to the Executive Regulation; before the Regulation is issued, any self-devised notification procedure has no regulatory basis. On the trade-off, for anything intended to be handled as a minor change, submit a written enquiry to EDE first and keep it on file, using the reply as the basis for execution, rather than following the company’s change classification from the EU or the US.

Insight 3: The consequences of not declaring a change fall on Article 17 and Article 33. The judgment is that the real risk is not limited to a supplementary declaration but points to revocation of the registration and revocation of the import permit. The reason is that Article 17 lists the revocation scenarios and Article 33 empowers revocation of import and export permits, and neither depends on whether the company was aware. On the trade-off, change management should be managed together with renewal under Article 7 (5 years), submitting the change ledger as part of the renewal dossier.

4. Practical recommendations

• Build a change classification table checked item by item against Article 6(a)-(h): any change touching one of the conditions is classified as major and requires re-approval.
• Treat changes of manufacturing site, of labeling and instructions for use, and of the applicant or MAH entity as major changes by default and prepare the dossier accordingly; do not presume them minor.
• For anything intended to be handled as a minor change, submit a written enquiry to EDE first and keep it on file, using the reply as the basis for execution instead of classification experience from other markets.
• Manage the change ledger together with the Article 7 5-year renewal, submitting the change history and evidence together at renewal.
• Verify changes against the import stage at the same time: after a labeling or instructions-for-use change, confirm that the documents under the import permit match the physical goods before release.
• Agree with the responsible entity on the obligation and deadline for reporting change information upward, so that it does not continue importing and distributing under the old version.

5. Verification checklist

• □ A change classification table has been built, with the yardstick being whether any condition of Article 6(a)-(h) is touched
• □ Changes of manufacturing site, labeling and instructions for use, and applicant or MAH entity are prepared on the major change path
• □ Written EDE replies have been obtained and archived for anything intended to be handled as a minor change
• □ The change ledger is scheduled together with the Article 7 5-year renewal node
• □ After labeling and instructions-for-use changes, consistency between import documents and physical goods has been verified
• □ The obligation and deadline for reporting change information are written into the agreement with the responsible entity
• □ The revocation risks under Article 17 and Article 33 have been assessed and response records retained

Further reading: Article No. 44, Post-Market Surveillance Reporting and PSUR: The 70-Day and 90-Day Rules and the Two-Year Cycle; Article No. 48, Penalties and Appeals: Articles 160, 162 and 168 and the AED 1,000-1,000,000 Range; Article No. 7, The 8 Statutory Conditions for Obtaining Marketing Authorization: An Item-by-Item Breakdown of Article 6(a)-(h).

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team manages adverse event reporting and recall coordination with MOHAP, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com