01. 在澳門如何取得醫療相關的牌照?

前言

假如你想在澳門開設及經營與醫療服務相關的場所，你必須取得澳門政府發出的“執照”。具體場所包括：醫院、診所或綜合性診所、衛生中心、衛生所、產院、護理中心、臨床分析實驗室及放射實驗室、診斷中心、治療中心及康復中心等。

其實，以上各種場所（除醫院外）的大部分執照發出的要求都大同小異。在此，我們以最常見的治療中心（或稱綜合診所、診所等）為例。

Introduction 

If you wish to establish and operate a healthcare facility in Macau, you must obtain a "licence" issued by the Macau government. These facilities include hospitals, clinics or polyclinics, health centres, health stations, maternity homes, nursing homes, clinical analysis laboratories, radiology laboratories, diagnostic centres, treatment centres, and rehabilitation centres.

Generally, the licence requirements for these facilities (except hospitals) are quite similar. Here, we use the most common example: a treatment centre (also known as a polyclinic or clinic).

如何選擇選擇地點開設場所?

其實場所選擇的要求相當寬鬆，包括以下選項：

• 所有商業用途的地舖及樓上舖；

• 商場之商業部份；

• 住宅單位#；

• 社設用途#及寫字樓用途之物業等。

#由於早年澳門衛生司對傳染病控制的考慮，已經不再接納在住宅開設診所的新申請。但是原本已取得執照的診所仍然可以繼續經營。另外，若希望於社設用途開設診所則需注意對其經營的細則可能會有其他要求。

假若你租用或購買的地方完全沒有間隔和消防上的更改，你可以完成必要的設施更改並接完成消防驗收後，直接向衛生局提出發牌申請。但倘若你租用或購買的地方有任何更改，或將單位合併或分割，則需要事先向土地工務局作出申請並獲批後，才可向衛生局申請，並且近年要求於發牌前需要取得工務局的完工證明信。

How to Choose a Location for Setting Up a Facility?

The requirements for choosing a location are quite flexible and include the following options:

• All commercial ground floor and upper-floor shops;

• Shopping centres commercial area;

• Residential units#;

• Properties intended for social# and office.

#Due to earlier considerations by the SSM (Macau Health department) for the control of infectious diseases, new applications for setting up clinics in residential units are no longer accepted. However, clinics that have already obtained licences can continue to operate. Additionally, if you wish to establish a clinic in a property intended for social use, you should be aware that there may be additional operational requirements.

If the place you rent or purchase does not have any modifications or fire safety issues, you can complete the necessary facility adjustments and pass the fire safety inspection before applying directly to the SSM for a licence. However, if there are any modifications, or if you are merging or dividing units, you need to first apply to the Land, Public Works and Transport Bureau for approval before applying to the SSM. In recent years, it is also required to obtain a completion certificate from the Public Works Bureau before the licence is issued.

有關場所人員之聘任問題。

當你需要開設診所，按照84/90/M第五條之相關規定如下。 

“於有關場所擔任技術指導職務之人士及欲提供衛生護理服務之人士或擔任提供衛生護理服務助理技術員職務之人士，須於衛生司登錄”。

按照人類聽得懂的語言去解釋，即是你最少需要聘用一名在澳門衛生局認可的醫療人員(醫生)在你的診所任職。需要注意的是，需然法規內有訂明在中華人民共和國政府官方認可之教育場所均可接受在澳門取得醫生資格。但是，除了你經營的是"醫院"以外，衛生局只接受具澳門居民身份的人仕去註冊成為醫生。簡單來說，澳門的私人診所或醫療中心並不能騁任外籍醫生。其他人員則沒有太多的要求。

Hiring Staff for Medical Facilities

When setting up a clinic, you must comply with Article 5 of Decree Law No. 84/90/M. This regulation states that individuals who serve as technical directors or provide healthcare services must be registered with the SSM.

In simple terms, you must hire at least one medical professional (doctor) recognised by the SSM to work at your clinic. Although the law allows qualifications obtained from officially recognised educational institutions in the P.R.C. China, butSSM only accepts Macao residents for registration as doctors in private clinics or medical institutions, , unless you are operating a hospital. Therefore, private clinics or medical centres in Macau cannot employ foreign doctors. There are fewer requirements for other staff members.

Q&A

這類執照的主管部門(權限實體)是誰? 該到那裡去申請?

澳門特別行政區衛生局─醫務活動牌照科 

地址：澳門青洲新街青怡大廈第一座2樓

有關疫苗

根據澳門法規，本澳的所有疫苗只能由已註冊的“藥物產品出入口及批發商號”進口，而每次進口均需取得衛生局發出的“疫苗的進口預先許可證”。同時，衛生局亦不會允許私家診所儲存疫苗。簡單來說，私人診所可以提供疫苗注射服務，但不能自行進口和儲存疫苗。

有關人工生育

人工生育主要包括人工授精（IUI）和試管嬰兒（IVF）兩類。目前，澳門法規定明，只有“經許可的單醫學輔助生殖技術僅得在仁伯爵綜合醫院及設有急診部、產科及新生兒深切治療部的私人衛生單位。”即是普通診所並不能提供相關服務。倘若你以人工生育為目的申請專門的診所或醫療機構執照，相關的門檻也十分之高。目前只有澳門政府的仁伯爵綜合醫院（山頂醫院）提供此項服務。

有關境外之認可(互認)

根據大灣區推出的一系列政策，具澳門執業資格的醫生可以在中國大陸廣東省橫琴開設診所。另外，根據《中華人民共和國澳門特別行政區政府與葡萄牙共和國政府關於促進文憑與學位自動認可的諒解備忘錄》，本澳醫科大學的學歷可以與葡萄牙互認。另外，在本澳訓練的醫生亦可到各葡語國家會員國就業。

有關醫學美容

澳門法例規定，凡涉及手術、服務宣稱有醫學療效，或過程中使用處方藥物的美容行業，均超出了美容院的經營範疇，需領有醫療牌照。

有關寵物醫院

在澳門，寵物醫院和上述提到的醫療場所法律概念完全不同，管轄的政府部門也不是衛生局而是市政署，法規主要為4/2023《動物診療及商業業務法》及7/2024《動物診療及商業業務法施行細則》。

Which Authority Oversees These Licences and Where to Apply? 

The responsible authority is the SSM, specifically the Medical Activity Licensing Division. Address: 2/F, Block 1,Edifício Cheng I , Rua Nova da Ilha Verde , Macau.

Vaccines 

According to Macau regulations, all vaccines must be imported by registered "pharmaceutical import and wholesale companies", and each import requires a "pre-import permit" issued by the SSM . Private clinics are not allowed to store vaccines. In short, private clinics can provide vaccination services but cannot import or store vaccines themselves.

Assisted Reproduction 

Assisted reproduction mainly includes intrauterine insemination (IUI) and in vitro fertilisation (IVF). Macau regulations stipulate that approved medical assisted reproduction techniques can only be performed at Conde S. Januário General Hospital or private healthcare institutions with emergency departments, obstetrics, and neonatal intensive care units. Ordinary clinics in Macau cannot offer these services. The threshold for applying for a licence for a specialised clinic or medical institution for assisted reproduction is very high. Currently, only Conde S. Januário General Hospital provides this service.

Recognition and Reciprocity

Under a series of policies introduced by the Greater Bay Area, doctors qualified to practice in Macau can open clinics in Hengqin, Guangdong Province, China. According to the "Memorando de Entendimento entre o Governo da Região Administrativa Especial de Macau da República Popular da China e o Governo da República Portuguesa que Conduza ao Reconhecimento Automático de Diplomas e Graus Académicos ", medical qualifications obtained from Macau universities are recognised in Portugal. Doctors trained in Macau can also work in Portuguese-speaking countries.

Medical Aesthetics

 Macau law stipulates that any beauty services involving surgery, medical efficacy claims, or the use of prescription drugs exceed the operational scope of beauty salons and require a medical licence.

Pet Hospitals 

In Macau, pet hospitals are legally distinct from the aforementioned medical facilities, and they are regulated by the Municipal Affairs Bureau, not the SSM. The relevant regulations are Law No. 4/2023 "Animal Diagnosis and Commercial Operations Law" and Administrative Regulation No. 7/2024 "Implementation Regulations for Animal Diagnosis and Commercial Operations Law".

適用法例

84/90/M; 20/98/M；醫學輔助生殖技術指引 澳門特別行政區公報第 19 期 — 2017 年 5 月 10 日第12/SS/2017號批示；19/2016、16/2008及28/2003號行政法規；7/2003號對外貿易法.

有用連結

澳門特別行政區衛生局 https://www.ssm.gov.mo/portal/

土地工務局             https://www.dsscu.gov.mo

R.S.E  F.Chan 03.2025更新

http://www.fnsi-macau.com

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