ANVISA and Hong Kong Department of Health Sign Cooperation MoU

Brazil's ANVISA and the Department of Health (DH) of the Government of the Hong Kong Special Administrative Region have signed a Memorandum of Understanding (MoU) on bilateral cooperation and the exchange of information. The signature page dates the MoU 23 September 2026. It was signed in English and Portuguese, and the English text prevails if the two diverge; ANVISA also publishes the Portuguese text. Hong Kong's government announced the signing on 23 September 2026: the MoU was signed in Hong Kong, witnessed by the Secretary for Health. ANVISA announced the MoU on 28 September 2026 as the close of one of the main stages of its mission to China.

The MoU is a cooperation framework, not a regulatory change. It states that it "does not constitute a treaty or an international agreement". It also states that it "is not intended to create any legally binding obligations, including to share confidential information between the Participants". It does not restrict either authority's legal powers. It does not change how medical devices are registered in Brazil or listed in Hong Kong, and it says nothing about either authority recognizing the other's approvals.

Hong Kong's announcement places the MoU in a wider plan. It says a mechanism "will be established" for information exchange and cooperation on the regulation of medicines and medical devices, among other medical products. It also says Hong Kong will establish a Centre for Medical Products Regulation (CMPR) in 2026, and describes the collaboration with ANVISA as "the first step" in the CMPR's strategy of deepening collaboration with overseas regulators. The announcement does not say how this affects medical device listing in Hong Kong.

What the MoU covers

• Areas: cooperation and information exchange within each authority's field of competence, including pharmaceutical ingredients, drugs, biological products, traditional medicinal products, medical devices, private healthcare facilities and tobacco control. The MoU acknowledges that the two authorities may have jurisdiction over specific products, for which they may have different definitions.
• Information exchanged: the MoU applies to information exchange "to the extent jointly decided" by the two authorities. Exchange is intended to cover the regulation of products and services, including policies, guidelines, standards, laboratory testing, pre-market assessment, post-market vigilance, compliance, good manufacturing practices and assessment of clinical trials. Each authority may use information exchanged under the MoU as a basis for its own regulatory decisions.
• Exclusions: two kinds of information are excluded and will not be exchanged in any case. These are personal data, such as medical files, and information subject to a confidentiality obligation whose disclosure would breach the authority's contractual obligations or undertakings to a third party.
• Activities: cooperation will be encouraged on the basis of mutual benefit and to the extent appropriate and/or permitted by each authority's laws and regulations. It includes, but is not limited to, experts taking part in meetings, scientific conferences, workshops and seminars, as decided by the authorities; collaboration on training courses, seminars and workshops; and joint projects. Any initiative will be formalized in a mutually decided work plan and is subject to available funds and personnel.
• Confidentiality: information exchanged is treated as confidential unless the authorities decide otherwise in writing. It is not disclosed to third parties without the providing authority's prior written consent. Exceptions include disclosure required by a law or court decision, with advance notice where possible, and disclosure to staff and advisers engaged in performing the MoU who are bound to confidentiality. The confidentiality provisions also do not apply to information the receiving authority can show was already lawfully known to it, already public or later made public through no fault of its own, received from a third party without breach, or developed independently.
• Term: the MoU took effect on signature and is valid for five years. It renews automatically for a further five years unless either side gives notice of non-renewal, and either side may end it with 30 days' written notice.

The mission to China

ANVISA and Hong Kong's government report that the Hong Kong programme included visits to the Chinese Medicine Hospital of Hong Kong, the city's newest hospital dedicated to traditional Chinese medicine, and to the Government Chinese Medicines Testing Institute. In Beijing, the delegation visited the National Cancer Center of China. In Hainan, it visited the Bo'ao Lecheng special medical zone. ANVISA notes that the zone allows, under specific conditions, the use of certain therapies not yet approved locally but already authorized by foreign reference authorities.

What this means for device manufacturers

Pure Global analysis:

• No change to market access: the MoU creates no reliance or recognition pathway for applicants, and manufacturers cannot rely on it in a submission. Registration with ANVISA and listing in Hong Kong continue under their existing requirements.
• Exchange only if jointly decided: if the authorities jointly decide to exchange device information, each may use it as a basis for its own regulatory decisions. Neither authority has said what specific information will be exchanged. Information subject to a confidentiality obligation whose disclosure would breach the authority's contractual obligations or undertakings to a third party is excluded.
• No action needed now: the MoU says initiatives will be formalized in a mutually decided work plan. It does not say whether that plan will be published, and it does not mention reliance on, or recognition of, either authority's approvals.

For context, see Pure Global's coverage of ANVISA's March 2026 health mission to China and our Brazil and Hong Kong market pages. In Hong Kong, the voluntary Medical Device Administrative Control System (MDACS) listing is operated by the Medical Device Division within the Department of Health.