Permit for Premises Providing Healthcare Services – Resumption Application

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How to Apply

Time of application

Before the expiration of the approved suspension period.

Application procedures and documents required

The vetting process consists of two stages: (1) technical review; (2) on-site inspection and issue of permit.

I. Technical review:

Applicants are required to submit the following required documents:

1. List of required documents for the application of permit resumption for premises providing private healthcare services;
2. Letter of application for permit resumption from the premises providing private healthcare services;
3. Copy of the applicant’s identification document;
4. Establishment plan of the premises indicating the objectives intended to be achieved with the establishment of the premises, a description of the activities to be developed in the premises, resources to be allocated to its operation, and the action plan for project execution;
5. Business Registration Certificate issued by the Commerce and Movable Property Registry (can be exempted if already registered with the Commerce and Movable Property Registry); for applicants who are a legal person, a certified copy of the incorporation document of the applicant entity within the last 3 months, relevant Articles of Association or a copy of the Macao SAR Official Gazette where such information was published;
6. Declaration of Acceptance made by the health professional appointed as technical director in the premises (can be exempted if the applicant is the technical director);
7. Written inspection report issued by the Real Estate Registry (can be exempted if the premises has been registered with the Real Estate Registry) or the building utilization permit issued by the Land, Public Works and Transport Bureau (DSSOPT);
8. Letter of application for medical advertising;
9. Sketch of advertisement/sign (Note: This can either be in the form of a computer print-out or hand drawing; in the latter case, all words thereon should be presented in a clear and legible way using block letters.
10. List of health professionals and technicians who will perform the functions of technical direction of the premises, provide healthcare services or perform auxiliary technical functions (Note: The applicant must provide information on at least two personnel, while the information of the remaining staff can be submitted at a later date as prescribed by the Health Bureau.)
11. Consultation timetable (Note: The applicant must provide information on at least two personnel, while the information of the remaining staff can be submitted at a later date as prescribed by the Health Bureau.)
12. Design drawing of the facilities for the premises and descriptive memorandum of the facilities and equipment (Note: Plans, sections and elevations should be prepared in PDF format at a scale of 1:50 or 1:100, with express indication of the scale to which such drawings are prepared.) (Note: Relevant drawings and information will be used for technical review only);
13. Copy of the policy of professional civil liability mandatory insurance (Note: can be submitted within 15 days counting from the date following the day of receipt of the notice of authorization for commencement of business;

II. On-site inspection and issue of permit

For premises where the works have been completed, applicants should submit the following documents to request a site inspection by the Health Bureau:

1. List of required documents for the application of resumption of permit for premises providing private healthcare services;
2. Design drawing of the facilities in the premises, as per scenarios A and B below:

A. For premises with a net floor area of no more than 120m2 whose works do not involve altering the use or floor area of the unit or the building structure, nor do they affect the normal functioning of any fire system in the unit, the following documents should be submitted to the Health Bureau:
A1.  The original plan approved by DSSOPT;
A2.    Plans, sections and elevations drawn to a scale of 1:50 or 1:100, with express indication of the scale to which such drawings are prepared (Note: Relevant submissions should be in PDF format, the information provided will be used for site acceptance inspection);
A3.    Descriptive memorandum of the facilities and equipment in the premises (Note: Relevant submissions should be in PDF format, the information provided will be used for site acceptance inspection).

B. For premises whose works involve altering the use or floor area of the unit or the building structure, or affect the normal functioning of any fire system in the unit, the applicant should submit to the Health Bureau the “descriptive memorandum of the facilities and equipment in the premises” (Note: Relevant submissions should be in PDF format, the information provided will be used for site acceptance inspection), as well as the following documents issued by DSSOPT:
B1.     In the case of completion of works
(1).     Copy of the approval letter for the project application;
(2).     Plans, sections and elevations drawn to a scale of 1:100 with the approval chop of DSSOPT (Note: Relevant submissions should be in PDF format, the information provided will be used for site acceptance inspection);
(3).     Notice of completion of works (N1);
(4).     Copy of receipt.
B2.     In the case of modification works:
(1).     Copy of the approval letter for the modification (alteration) project application;
(2).     Plans, sections and elevations drawn to a scale of 1:100 with the approval chop of DSSOPT (Note: Relevant submissions should be in PDF format, the information provided will be used for site acceptance inspection);
(3)      Copy of tax payment receipt.

3.  Inspection request form from the premises providing private healthcare services.

Location of Application and Service Hours

Location of application: Medical Activity Licensing Unit, 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)

Fees

Free.

Application Processing Time

Generally 45 working days (subject to the actual circumstances of the case).

The vetting period will be suspended in the following situations:

（1）Technical review:
1)      If change of or additional application information is necessary, the vetting period will be suspended from the time when the procedure for change of or additional information is instigated, until relevant information is presented to the Medical Activity Licensing Unit.
2)      If there is a need to consult opinions of relevant functional departments, the vetting period will be suspended from the time when the consultation procedure is instigated, until the opinions are presented to the Medical Activity Licensing Unit.

（2）On-site inspection and issue of permit:
1)    After field visit by the Sanitary Authority, the premises is considered not ready for inspection, the facilities or equipment of the premises are not in conformity with the sanitary requirements, the premises is not established in accordance with the “Regulations for the establishment of polyclinics and medical centres”, or other situations where re-inspection is needed;
2)    The setting up of the premise does not meet the laws and regulations in Macao in relation to renovation works, fire prevention and safety;
3)    The vetting period is suspended from the time when the initial site inspection is proposed, until a favourable opinion from the Sanitary Authority is returned to the Medical Activity Licensing Unit.

Remarks/Notes for Application

（1）Technical review:

1. If the documents prescribed in items 3 and 5 have been submitted before and all the information remains unchanged, the applicant may furnish a declaration that relevant documents have been kept in the files of the Health Bureau.
2. Failure to submit all necessary documents will affect the commencement of the vetting process;
3. Applicants who fulfill the licensing requirements will receive notice of authorization to establish the premises from the Health Bureau, and the establishment period is six months;
4. The above period may be extended upon request to the director of the Health Bureau, based on the facts that justify the delay of the establishment of the premises and with indication of the intended extension period;
5. To help make the vetting process as smooth and speedy as possible, applicants should provide full and complete application information and set up the premises in accordance with the laws and regulations in Macao in relation to renovation works, fire prevention and safety, sanitary requirements and others, as well as the “Regulations for the establishment of polyclinics and medical centres”.

（2）On-site inspection and issue of permit:

1.  Before the expiration of the establishment period approved by the Health Bureau, the interested parties should apply for an inspection of the facilities;
2. If items I and II in the “List of required documents for permit application for premises providing private healthcare services” have been submitted for technical review and there is nothing to change or add, it is not necessary to resubmit the same when applying for on-site inspection;
3. If the resumption application of the premises is lodged after the completion of the works, it is not necessary to submit the documents described in item II of the “List of required documents for permit application for premises providing private healthcare services”. In this case, the applicant should submit the documents referred to in items I, III and IV of the List and pay the relevant fees in order to apply for on-site inspection promptly;
4. If the premises does not involve alteration works, but is inconsistent with the original plan approved by DSSOPT, the updated documents indicated in item III and those indicated in item IV of the “List of required documents for permit application for premises providing private healthcare services” should also be submitted;
5. The Health Bureau will carry out the inspection within 15 days after receipt of the site inspection application, and prepare a report.
6. For the purposes of arranging on-site inspection and issue of permit, the applicant must ensure that the application information are modified or supplemented in accordance with the opinions of the Health Bureau.
7. In the event of defective or inadequate facilities, the applicant will be notified to make amends or improvements within a specified period of time; if no action is made upon the expiration of the specified period, the authorization for establishment will become invalid and the licensing application archived.
8. All amends and improvements are subject to re-inspection, which is to be carried out at the end of the specified period referred to in the previous paragraph.
9. The application will be archived when, due to the fault of the applicant, the establishment of the premises is not carried out on time.
10. If on-site inspection indicates compliance with relevant rules and regulations of the Health Bureau, the subsequent follow-up procedures are as follows:
    1)     The applicant will be notified of the approval of the resumption application, and the dispatch approving the relevant application will be published in the “Macao SAR Official Gazette” after the Deputy Director of the General Healthcare Sub-board has ordered the dispatch；
    2)   Within 15 working days after the day of receiving the notice of authorization for the commencement of healthcare activities, the applicant should go to the Health Bureau to:
    i.    Settle the balance which is 50% of the licensing fee;
    ii.   Submit a copy of the policy of professional civil liability mandatory insurance (if not already submitted), in order to provide proof of compliance with the stipulations of article 36 of Law no. 5/2016 – “Legal Regime of Medical Malpractice” and articles 3 and 4 of Administrative Regulation no. 5/2017 as amended by Administrative Regulation no. 49/2021.

Relevant Specifications or Requirements

Links to relevant information:

1. Guidelines on the Naming of Premises Providing Healthcare Services
2. Application Guideline for Installation of Medical Diagnostic X-ray Apparatus and List of Equipment with Radioactive Sources or Radiation Apparatus for Medical Use
3. Requirements and Application Procedures for Magnetic Resonance Diagnosis System for Medical Use
4. Norms for Sterilizing Instruments and Materials Used in Invasive Medical Procedures in Small Private Helthcare Settting
5. Advertising regulations for local medical professionals or entities that provide healthcare services in the private system of Macao
6. Regulations for the establishment of polyclinics and medical centres
7. Normative guideline for private health units with operation theatre
8. Important notes for private health units submitting self-made floor plan

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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