Class I and IIa Light Evaluation Under Article 9 of the 2021 Regularisation Order

1. Key takeaways

Article 9 of the Ministerial Order of 10 May 2021 on regularisation gives Class I and IIa devices a light evaluation route: the technical evaluation covers only the technical regulations evaluation and the clinical data evaluation where applicable, rather than the full four phases of Article 25 of Décret exécutif n° 20-324. Article 9 lists four situations to which the light evaluation applies.

The four situations are parallel. Only the first is defined by device class; the other three are additional conditions that can qualify a device regardless of the class logic. Reading all four as automatic entitlements, or reading only the first and ignoring the rest, both misstate how the provision actually works.

The light evaluation is the single biggest time saver inside the regularisation channel, but it is not self-executing. The applicant benefits most by documenting eligibility for the four situations affirmatively, so that the reduced scope of the evaluation is accepted without a further round of questions.

2. Legal basis

1. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant les modalités de régularisation du dossier d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 on the regularisation of the homologation dossier, JORADP No. 55, published 14 July 2021, pages 24–26, 14 articles): Article 8 (the composition of the technical evaluation), Article 9 (the four applicable situations) and Article 10 (Class IIb and III devices remain subject to Article 25).
2. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 22 November 2020 on the procedures for the homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 25 (the full four-phase evaluation).
3. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 22 November 2020 on the procedures for the homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 17 (the four-level classification).
4. Décret exécutif n° 21-82 du 11 Rajab 1442 correspondant au 23 février 2021 relatif aux établissements pharmaceutiques et les conditions de leur agrément (Executive Decree No. 21-82 of 23 February 2021 on pharmaceutical establishments and the conditions of their approval, JORADP No. 14, published 28 February 2021, pages 9–12, 29 articles): Article 10 (import establishments import according to an import plan).

3. Expert insights

Insight 1: the four situations of Article 9 are introduced by the word notably, not by a closed list.

The wording of Article 9 is that the technical evaluation of its second paragraph applies to certain devices, notably the devices listed. The term notably signals an illustrative enumeration and preserves discretion for the ANPP. GRZAN’s handling is therefore to submit the four situations as argumentation, with evidence attached, rather than to treat them as self-executing conditions that the authority is bound to apply mechanically.

Insight 2: the second situation requires valid approval on both the manufacturing and testing sides.

The second situation covers devices manufactured in an approved pharmaceutical production establishment and tested in an approved quality control laboratory. Both approvals must be valid, and the activity type recorded on the production establishment’s agrément must include manufacturing. A lapsed approval or an activity type that omits manufacturing takes the device out of this situation even if everything else is in order.

Insight 3: the third situation writes the import plan into the conditions.

The third situation covers devices imported under an import plan issued to an approved pharmaceutical import establishment. This connects with Article 10 of Executive Decree No. 21-82, which governs the duties of import establishments: importation is not accomplished by the homologation certificate alone, but requires the import plan as a management tool. The certificate and the plan must point at the same device and the same establishment.

Insight 4: the fourth situation is a zero-vigilance record, and it is the item companies can verify themselves.

The fourth situation requires that the device has not been the subject of any device vigilance signal, either in the country of origin or in Algeria. This can be checked without the authority: pull the vigilance databases of the origin-country regulator and the vigilance records of the local partner, and issue a written attestation. GRZAN recommends attaching this attestation to the dossier as a routine exhibit, because it is cheap to prepare and directly supports the light evaluation request.

4. Practical recommendations

1. Compare the device against each of the four situations of Article 9 and issue a written justification for the light evaluation as a dossier exhibit.
2. Verify the validity periods and the activity types of both the production establishment approval and the quality control laboratory approval.
3. Obtain the import plan document from the local import establishment and confirm the device falls within its coverage.
4. Pull vigilance records for the country of origin and Algeria, and issue the written zero-vigilance attestation.
5. Even when relying on the light evaluation, keep the materials required for the four phases of Article 25 ready, in case the ANPP requests completion.
6. For Class IIb and III devices, prepare directly for the full four phases instead of spending effort arguing for the light evaluation.

5. Verification checklist

• □ A written justification for the light evaluation has been issued and filed as a dossier exhibit.
• □ The validity periods and activity types of the production and laboratory approvals have been verified.
• □ The import plan document has been obtained and the device confirmed within its coverage.
• □ The written zero-vigilance attestation for the country of origin and Algeria has been completed.
• □ The materials for the full four phases are ready in case completion is requested.
• □ Class IIb and III devices have been prepared directly to the full four phases.

GRZAN determines whether a device qualifies for the light evaluation under Article 9 and builds the supporting argumentation, classification analysis and evidence package for the Algerian regularisation channel. If your Class I or IIa device could skip two evaluation phases, GRZAN can help you document it convincingly. For support, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.