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Healthcare in Brazil: foreign capital in hospitals and health plans, ANS authorization and Anvisa drug registration

Last verified: 2026-10-27 · Status: Stable

The Constitution bars foreign capital in healthcare unless a law allows it, and since 2015 the law allows foreign control of hospitals, clinics and family planning services, while health plan operators have been open to foreign shareholders since 2001. Health plan operators need an ANS operating authorization, sell under strict minimum coverage and renewal rules, and lose the authorization if they do not start selling within 180 days. Medicines and health products cannot be sold before Anvisa registration, decided within 120 days for priority and 365 days for ordinary drug applications.

Key facts

Maximum Anvisa decision time, priority medicine registration	120 daysLei nº 6.360 art. 17-A § 2 I, as of 2026-10-27 · in force
Maximum Anvisa decision time, ordinary medicine registration	365 daysLei nº 6.360 art. 17-A § 2 II, as of 2026-10-27 · in force
Maximum validity of a product registration before renewal	10 yearsLei nº 6.360 art. 12 § 1, as of 2026-10-27 · in force
Days for a new health plan operator to start selling before losing authorization	180 daysLei nº 9.656 art. 8 § 2, as of 2026-10-27 · in force
Days of non payment in 12 months before an individual plan may be terminated	60 daysLei nº 9.656 art. 13 sole paragraph II, as of 2026-10-27 · in force

The rule

1. Healthcare is open to private initiative, but direct or indirect participation of foreign companies or capital in healthcare is prohibited except where a law allows it. Private institutions may join the public health system as complements, preferring non profit entities, and public funds may not subsidize for profit institutions.Constitution of Brazil, Art. 199 caput and §§ 1 to 3, 1988-10-05 official text · verified 2026-10-27

2. Foreign companies or capital may participate directly or indirectly, including with control, in: donations from UN linked and cooperation entities and financing and loans; legal entities that set up, run or operate general, philanthropic or specialized hospitals, polyclinics and general or specialized clinics, and family planning activities and research; non profit health services kept by companies for employees and dependants; and other cases set by specific law.Lei nº 8.080 (Health System Law), art. 23 as worded by Lei nº 13.097 of 19 January 2015, Art. 23 I to IV, 2015-01-19 official text · verified 2026-10-27 · changed: Lei nº 13.097 of 19 January 2015 opened hospitals and clinics to foreign control.

3. Individuals and legal entities resident or domiciled abroad may form or hold capital, including capital increases, in Brazilian incorporated private companies that operate health plans.Lei nº 9.656 (health plans), as worded by MP nº 2.177-44 of 24 August 2001, Art. 1 § 3, 1998-06-03 official text · verified 2026-10-27

4. To obtain an ANS operating authorization, a health plan operator must register with the regional medical or dental council, describe own and third party services, facilities and equipment, specify qualified technical staff, prove service capacity and economic and financial viability, and specify the geographic area covered. The authorization is cancelled if the operator does not sell plans within 180 days of its ANS registration.Lei nº 9.656, as worded by MP nº 2.177-44, Art. 8 I to VII and § 2, 1998-06-03 official text · verified 2026-10-27

5. The reference plan covers outpatient and hospital care, births and treatments carried out in Brazil, in ward standard and intensive care when needed, for the diseases in the WHO international classification, with listed exclusions such as experimental treatment, cosmetic procedures, artificial insemination and imported unregistered medicines.Lei nº 9.656, as worded by MP nº 2.177-44, Art. 10 I to X, 1998-06-03 official text · verified 2026-10-27

6. Plans renew automatically with no renewal fee. Individual plans have a minimum term of one year, and the operator may not recount waiting periods or suspend or terminate the contract except for fraud or non payment for more than 60 days in the last twelve months, with proven notice by the 50th day of default, and never while the holder is hospitalized.Lei nº 9.656, as worded by MP nº 2.177-44, Art. 13 caput and sole paragraph I to III, 1998-06-03 official text · verified 2026-10-27

7. No medicine or other product under the law, including imports, may be manufactured, offered for sale or delivered for consumption before registration. Anvisa sets the registration renewal period of up to 10 years by risk, registration outside the special regimes of arts. 17-A, 21 and 24-A is granted within at most 90 days of filing, and renewal must be requested in the first half of the last year of validity, or the registration lapses.Lei nº 6.360 (health surveillance of medicines), as amended by Lei nº 13.097 of 2015 and Lei nº 13.411 of 28 December 2016, Art. 12 caput and §§ 1, 3, 6 and 7, 1976-09-23 official text · verified 2026-10-27

8. Final decisions on medicine registration must be taken within 120 days for priority applications and 365 days for ordinary ones, and on post registration changes within 60 and 180 days, extendable once by up to one third. Information requests suspend the clock and must be consolidated into a single request.Lei nº 6.360, art. 17-A included by Lei nº 13.411 of 28 December 2016, Art. 17-A §§ 1, 2, 5 and 6, 2016-12-28 official text · verified 2026-10-27

Activity	Foreign capital	Rule
Hospitals, polyclinics, clinics	Allowed, including control	Lei nº 8.080 art. 23 II a
Family planning activities and research	Allowed, including control	Lei nº 8.080 art. 23 II b
Health plan operators	Allowed	Lei nº 9.656 art. 1 § 3
Other healthcare activities	Only where a specific law allows	Constitution art. 199 § 3; Lei nº 8.080 art. 23 IV

Where foreign capital may go in Brazilian healthcare.

Worked example

A foreign hospital group buys control of a Brazilian hospital chain and its captive health plan: the hospitals fall under the 2015 opening (Lei nº 8.080 art. 23 II a), the plan operator under Lei nº 9.656 art. 1 § 3, and the operator must keep meeting its ANS authorization conditions (art. 8). A new drug the group imports needs Anvisa registration first; an ordinary application has a 365 day decision clock, a priority one 120 days (Lei nº 6.360 art. 17-A).

Step by step

1. Map each target activity against Lei nº 8.080 art. 23 and Lei nº 9.656 art. 1 § 3.
2. For a health plan operator, file the ANS authorization with services, network, staff and viability, and start selling within 180 days.
3. Register medicines and health products with Anvisa before any sale or import for consumption.
4. Calendar registration renewals for the first half of the last year of validity.
5. Check merger control filing duties for the acquisition.

Common traps

Healthcare activities outside the cases listed in Lei nº 8.080 art. 23 remain under the constitutional ban unless another law opens them.
A health plan operator that registers but does not sell within 180 days loses its authorization.
Missing the renewal window makes the product registration lapse.
Individual plans cannot be cancelled for default without the 60 day threshold and notice by the 50th day.

Sources

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