Guidelines for Handling the Examination and Approval of the Establishment of Provincial Medical Institutions

来源: 发布日期:2025-01-22 16:22 【字体: 小   中   大

Matter

Examination and Approval of the Establishment of Provincial Medical Institutions

I. Service Recipients

Natural person; enterprise legal person; public institution legal person

II. Basis

Article 9 of the Regulation on the Administration of Medical Institutions (Order No. 149 of the State Council on February 26, 1994): To establish a medical institution, an entity or individual shall be subject to the examination and approval of the health administrative department of the local people’s government at or above the county level and obtain the written approval for the establishment of medical institutions, before undergoing other formalities with relevant departments. Article 53: The measures for the administration of the medical institutions established by foreigners within the territory of the People’s Republic of China and residents of Hong Kong, Macao and Taiwan regions in the Chinese mainland shall be separately developed by the health administrative department of the State Council. Item 1 of Appendix 1 to the Decision of the State Council on Matters Concerning 50 Administrative Approval Items to Be Canceled and Delegated to Lower Levels (G.F. [2013] No. 27): The examination and approval of the establishment of wholly-owned hospitals in the Chinese mainland by investors from Hong Kong Special Administrative Region, Macao Special Administrative Region or Taiwan Region shall be delegated to the health and family planning department at the provincial level.

III. Acceptance Conditions

i. Grade III hospitals, Grade III maternal and child health care hospitals, emergency centers, first-aid stations, clinical testing centers, Chinese-foreign joint venture or cooperative medical institutions, and wholly-owned medical institutionsby Hong Kong, Macaoor Taiwanservice providers.

ii. Under one of the following circumstances, no application shall be filed for the establishment of any medical institution: 1. An entity is unable to independently assume civil responsibilities; 2. an individual is serving a sentence or does not have full capacity for civil conduct; 3. medical personnel of a medical institution are on the job, resign from office due to illness, or retain the job with a suspension of salary; 4. medical personnel has had medical malpractice above grade two for less than five years; 5. the practicing license of the medical personnel has been revoked due to violation of the relevant laws, regulations and rules; 6. the legal representative or the primary person in charge of a medical institution is revoked of his Practicing License for a Medical Institution; and 7. other circumstances as specified by the health administrative departments under the governments of the provinces, autonomous regions and municipalities directly under the Central Government. Any individual falling under the circumstances as prescribed in items 2, 3, 4, 5 or 6 of the preceding paragraph shall not act as the legal representative or the primary person in charge of any medical institution.

iii. The Chinese-foreign joint venture or cooperative joint institution to be established shall meet the following requirements: 1. It shall be an independent legal person; 2. the total investment shall not be lower than RMB20million; 3. the proportion of equity or interest of the Chinese party to the Chinese-foreign joint venture or cooperative joint medical institution shall not be lower than 30%; and 4. the term of the medical institution shall not be longer than 20 years.

Article 6of the Implementation Measures of Hainan Province for the Administration of Internet-based Diagnosis and Treatment: If physical medical institutions conduct Internet-based diagnosis and treatment only through their registered physicians, they shall apply to the incorporation registration authority to add “Internet-based diagnosis and treatment” to their services. They may also apply to designate the Internet hospital as their secondary name. If physical medical institutions conduct Internet-based diagnosis and treatment through the physicians registering with both them and other institutions or if they partner with a third-party institution to establish an Internet hospital, they shall apply to the incorporation registration authority to add “Internet-based diagnosis and treatment” to their services. They shall also apply to designate the Internet hospital as their secondary name. It is feasible to apply to establish an independent Internet hospital by relying on a physical medical institution that has obtained the Practicing License for a Medical Institution. Independent Internet hospitals, which are established by relying on remote medical centers and primarily offer Internet-based diagnosis and treatment services, are encouraged to be established in designated key industrial parks within the province. These parks shall introduce appropriate supporting service measures.

IV. Application Materials

Circumstance I.

i. Does the physical medical institution newly applied to be established intend to add Internet-based diagnosis and treatment to its services, apply to designate the Internet hospital as its secondary name at the same time, or apply to establish an Internet hospital?

If “No”, the following materials shall be submitted:

1. An application for the establishment of a medical institution.

ii. Does the physical medical institution newly applied to be established intend to add Internet-based diagnosis and treatment into its services, apply to designate the Internet hospital as its secondary name at the same time, or apply to establish an Internet hospital?

If “Yes”,does it intend to partner with a third-party institution to establish the Internet hospital and build an Internet-based diagnosis and treatment service information system?

If “No”,the following materials shall be submitted:

1. An application for the examination and approval of the establishment of a provincial medical institution;

2. A cooperation agreement executed by the applicant and the physical medical institution for establishing the Internet hospital;and

3. A feasibility study report for the establishment.

iii. Does the physical medical institution newly applied to be established intend to add Internet-based diagnosis and treatment into its services, apply to designate the Internet hospital as its secondary name at the same time, or apply to establish an Internet hospital?

If “Yes”,does it intend to partner with a third-party institution to establish the Internet hospital and build an Internet-based diagnosis and treatment service information system?

If “Yes”,the following materials shall be submitted:

1. An application for the examination and approval of the establishment of a provincial medical institution;

2. A cooperation agreement with a third-party institution to build an Internet-based diagnosis and treatment service information system or a cooperation agreement executed by the applicant and the physical medical institution for establishing the Internet hospital, specifying the liabilities, rights and obligations of all parties regarding medical services, information security and privacy protection; and

3. A feasibility study report for the establishment.

Circumstance II.

For the establishment of Chinese-foreign joint venture or cooperative medical institutions, the following materials shall be submitted:

1. An application for the establishment of a medical institution;

2. Registration certificates, identity certificates of the legal representatives and certificates of creditworthiness issued by a bank of both parties to the joint venture or cooperative medical institution;

3. A project proposal executed by legal representatives of both parties to the joint venture or cooperative medical institution and a feasibility study report for the establishment of the Chinese-foreign joint venture or cooperative medical institution;and

4. Confirmation documents of assessment report presented by the state-owned asset administration department concerning the state-owned assets to be contributed.

V. Time Limits for Conclusion

Statutory time limit for the completion of handling: 30 business days

Promised time limit for the completion of handling: 10 business days

VI. Handling Results

Approval for the Establishment of Medical Institutions

VII. Charge Basis and Fee Rates

No charges

VIII. Handling Procedures

i. For the establishment of Chinese-foreign joint venture or cooperative medical institutions, it shall be submitted to the health administrative department at the provincial level for examination and approval upon preliminary examination by the health administrative department at the level of the districted city where the medical institution is located.

ii. 1. Acceptance (if the application materials are complete and consistent with the statutory form, the case shall be accepted in the administration examination and approval system after passing the examination);

2. Review (materials shall undergo professional review and proceed to the re-examination process after passing the preliminary examination);

3. Special processes (the time required for the expert review shall not be included in the promised time limit for handling the matters); and

4. Decision (the decision to approve or not to approve the handling of a case according to the re-examination opinions).

IX. Contact Information

Tel.: Approval Office of Hainan Provincial Health Commission at Hainan Provincial Government Service Center, 65203035

Address: Life and Education Services, 2/F, Hainan Provincial Government Service Center, No.3 South Wuzhishan Road, Meilan District, Haikou City, Hainan Province

Time: 08:00-12:00 and 14:30-17:30 from Monday to Friday (off at weekends and statutory holidays) (no seasonal clock change in Hainan)

Website: https://wssp.hainan.gov.cn/


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任何建议和意见请联系:hnswshjhsywyh@126.com

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