Client Alerts

ANS establishes deadlines and risk classification for its public release instruments

February 18th, 2025

On February 14, 2025, the Brazilian Supplementary Healthcare Agency (“ANS”) published Normative Resolution (“RN”) No. 626/25, which provides for the risk classification and public instruments for the release of economic activities within the scope of ANS regulation, according to Law No. 13,874/19, establishing the Declaration of Economic Freedom Rights, and its regulatory decree, Decree No. 10,178/19.

Public release acts are all acts issued by a public authority as a condition for carrying out an economic activity, as defined by Decree No. 10,178/19, which includes licenses, authorizations, concessions, registrations, permits, approvals, among others.

Previously, there was no single regulation for all ANS instruments and deadlines, which were established in different norms. The new RN consolidates all acts that require authorization from the ANS so that the regulated sector can begin its activities.

In this regard, RN. No. 626/25 establishes the 23 public acts under the ANS’s competence, as well as their respective risk levels and approval deadlines. If ANS does not issue a statement within the respective deadline, tacit approval will be considered.

Tacit approval due to the expiry of the deadline does not exempt the company from complying with the applicable regulations or from subsequent corrections, if identified during an inspection.

See below the deadlines and classifications established by the ANS

Instrument	Legal Basis	Deadline	Risk Level
Authorization for assuming corporate control, incorporation, merger, spin-off and dismemberment	Item XXII of Article 4 of Law No. 9,961, of 2000, with RN No. 525, of April 29, 2022, and ANS Normative Instruction No. 21, of April 29, 2022	90 days*	III
Authorization for voluntary disaffiliation from the operator through the Adequate Scale Program (“PEA”)	Article 9 of RN No. 530, of May 02, 2022	120 days*	III
Operator registration	Law No. 9,656, of 1998, with RN No. 543, of September 02, 2022	120 days*	III
Operating authorization for operators or benefit administrators registered with the ANS	Law No. 9,656, of 1998, with RN No. 543, of September 02, 2022	60 days**	III
Registering authorization for private healthcare plans	Item XX of Article 4 of Law No. 9,961, of 2000, regulated by RN No. 543, of September 02, 2022	60 days*	III
Authorization for adjustments and reviews of cash payments for private healthcare plans	Item XXII of Article 4 of Law No. 9,961, of 2000, regulated by NR. 565, of December 16, 2022	60 days*	III
Cancellation of operator registration/operating authorization at the operator’s request	Article 23 of RN No. 543, of September 02, 2022	60 days*	III
Registration of administrators	RN No. 520, of April 29, 2022	120 days*	III
Operator modality change	RN No. 531, of May 02, 2022; with RN No. 543, of September 02, 2022	90 days*	III
Transfer/redemption of financial guarantee assets	Articles 15, 16 and 17 of RN No. 521 of April 29, 2022	30 days*	III
Binding real estate as collateral (phase 1)	Articles 21 of RN No. 521, of April 29, 2022	30 days*	III
Binding real estate as collateral (phase 2)	Article 22 of RN No. 521, of April 29, 2022	30 days*	III
Removal of real estate as collateral	Articles 26 and 27 of RN No. 521, of April 29, 2022	30 days*	III
Annual prior authorization to transfer financial guarantee assets	Normative Resolution No. 519, of April 29, 2022	30 days*	III
Authorization to use internal methodologies to establish non-mandatory technical provisions.	Article 3, item VII, and Articles 19 to 22, all of RN No. 574, of 2023.	120 days*	III
Acceptance of the Term of Assumption of Economic and Financial Obligations (TAOEF)	Article 11 and 15 of RN No. 532, of May 02, 2022, with Article 20 of RN No. 523, of April 29, 2022	60 days*	III
Authorization to reduce regulatory capital factors	Article 12 of RN No. 518, of April 29, 2022, with Article 6 of RN No. 526, of April 29, 2022	120 days*	III
Cancellation of product registration	Item XVI of Article 4 of Law No. 9,961/2000, regulated by RN No. 543, of September 02, 2022, and by DIPRO Normative Instruction No. 28, of December 16, 2022	60 days*	III
Suspension of product registration	Item XVI of Article 4 of Law No. 9,961, of 2000, regulated by RN No. 543, of September 02, 2022, and by DIPRO Normative Instruction No. 28, of December 16, 2022	60 days*	III
Reactivation of product registration	Item XVI of Article 4 of Law No. 9,961, of 2000, regulated by RN No. 543, of September 02, 2022, and by DIPRO Normative Instruction No. 28, of December 16, 2022	60 days*	III
Change of a product’s trade name	Item XVI of Article 4 of Law No. 9,961 of 2000, regulated by RN No. 543 of September 02, 2022, and DIPRO Normative Instruction No. 28 of December 16, 2022	60 days*	III
Change of a product’s hospital network	Item XVI of Article 4 of Law No. 9,961, of 2000, regulated by RN No. 543, of September 02, 2022, and by DIPRO Normative Instruction No. 28, of December 16, 2022	60 days*	III
Portfolio transfer	Item XXXV, of Article 4 of Law No. 9,961/2000, regulated by RN No. 112, of 2005.	120 days*	III

* Counted from the date of delivery of the respective documentation required for the process.

** Counted from the date of product registration, applicable to all types of operators, except benefit administrators, for whom the maximum period is 30 days, counted from the date registration is granted.

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.