Licence and Permit of Private Healthcare Units – New Application

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How to Apply

Time of application

N/A

Application procedures and documents required

The applicant should submit the following to the Medical Activity Licensing Unit:

1. Application letter to the Director of Health Bureau, content of which should include the followings:
   1. Company name or name of natural person, as well as other identification information of the applicant;
   2. Domicile of legal entity or residence of natural person;
   3. Location and name of the premise;
   4. Information of the clinical management;
   5. Types of services to be provided.
2. The application letter should be attached with the following documents:
   1. Certified copy of identification document of the applicant, in case of legal entity, certified copies of incorporation/ constitution document of the applicant organization and the Articles of Association, or a copy of the “Macao SAR Official Gazette” where the concerned Articles of Association was published, as well as certified copies of the identification documents of the management team;
   2. The latest Certificate of Business Registration (companies registered with the Commerce and Movable Property Registry or charity organizations are exempted from submitting this document);
   3. A Certificate of Criminal Record of the applicant or the management team of the applicant entity (can be applied at the Identification Services Bureau (DSI), via self-service kiosks or the DSI website; the Certificate issued by DSI will be delivered to the Health Bureau);
   4. A detailed description of staff members and staff list, which is divided into the following four categories:
      1. List of professionals (including physicians, TCM doctors, dentists, nurses, pharmacists and diagnostic & therapeutic technicians) who are holders of Macao Resident Identity Card; their types of profession, posts and licence numbers should be indicated in the list;
      2. List of persons-in-charge of different wards and departments, with their duties and posts indicated in the list;
      3. List of workers who are holders of Macao Resident Identity Card, with their types of profession indicated in the list;
      4. List of non-local workers, with their types of profession indicated in the list.
   5. A structural plan of the building which complies with the current local regulations, together with the building utilization permit issued by the Land, Public Works and Transport Bureau;
   6. Functional plan, specification memorandum and design layout of the facilities, with signature of qualified technician, in which the healthcare unit operates (including the functional plan, specification memorandum and floor plan of the hospital and each floor of the blocks);
   7. Draft of internal regulations;
   8. Declaration of acceptance made by the designated person to provide technical guidance for the establishment (including the hospital director, hospital administration departments, nursing departments and pharmaceutical affairs department).

Note:

1. Within 15 working days after the day of receiving the approval letter for commencement of business, the applicant should submit to the Medical Activity Licensing Unit a copy of the policy of Professional Civil Liability Mandatory Insurance of Health Service Provider in order to provide proof of compliance with the stipulations prescribed in Article 36 of Law no. 5/2016 – “Legal Regime of Medical Malpractice” and Articles 3 and 4 of Administrative Regulation no. 5/2017 prior to the commencement of business.
2. Under subparagraph 2) of article 12 of Law no. 13/2019 “Cybersecurity Law” and paragraph 1 of article 10 of the “Regulation on Cybersecurity Management Standards”, operators must submit an yearly cybersecurity report in January to its supervisory entity, in which the general information of the operator, the cybersecurity protection level of information networks and systems, the implementation situation regarding this regulation throughout the year, cybersecurity incidents recorded, assessment results of security and potential risks of information networks and systems, as well as the implementation of  cybersecurity planning and improvement measures must be indicated.

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Location of Application and Service Hours

Location of application: Medical Activity Licensing Unit of the Health Bureau

Address: 2/F, Block 1 of Edifício Cheng I at Rua Nova da Ilha Verde, Macau (Ilha Verde Health Centre)

Service hours:
Mondays to Thursdays: 9:00am-1:00pm, 2:30pm-5:45pm
Fridays: 9:00am-1:00pm, 2:30pm-5:30pm
(Closed on Saturdays, Sundays and public holidays)

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Fees

1. The fee for the operation licence of a private healthcare unit is MOP4,400 (stamp duty included).
2. The fee for the permit of the establishment is MOP5,500 (stamp duty included).

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Remarks/Notes for Application

Specifications of the following documents should be submitted:

Paragraph 2.6, Functional plan/ specification memorandum/ design layout

• Plan and specification of each functional zone

1. Hospital administration departments
2. Medical departments
3. Paramedical departments

• Plan and specification of the supply system of each essential element and the waste disposal system

1. Water supply (specific water supply and quality assurance system) and sewage treatment system
2. Electricity supply system (emergency power supply system and emergency lighting system)
3. Air conditioning and ventilation system
4. Food supply system
5. Medical gas and vacuum system
6. Medical waste disposal system

• Plan and specification of safety system

1. Fire safety system
2. Security system
3. Dangerous goods management system

Paragraph 2.7, Internal regulations

• Quality assurance

1. Guarantee and improvement system (should include the organization chart of the hospital, general program of the hospital, as well as the important points to assure and improve the quality of different medical and paramedical departments)
2. Functional responsibilities of staff, moral regulation and training mechanism
3. Mechanism for handling complaints and medical incidents
4. Drug administration mechanism
5. Health records management system
6. Equipment maintenance system
7. Others

• Hygiene and safety

1. Regime of disinfection, sterilization, isolation and infection control
2. Laboratory biochemical safety system
3. Radiology safety protection system
4. Food hygiene safety system
5. Pest prevention system

• Emergency response

1. Contingency plan for disasters in Accident and Emergency Department
2. Contingency plan for biochemical contamination
3. Emergency evacuation program

Relevant Specifications or Requirements

Links to relevant information:

1. Application Guideline for Installation of Medical Diagnostic X-ray Apparatus and List of Equipment with Radioactive Sources or Radiation Apparatus for Medical Use
2. Requirements and Application Procedures for Magnetic Resonance Diagnosis System for Medical Use

Application Status Enquiry and Result Collection

Status enquiry: Please check the application status via the “Macao Government Service” mobile application (App) or the Macao SARG Portal (The applicant has to apply for an Online Account for Public Service in advance).

Collection of application result: In person.

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