I. Service Recipients

Natural person; enterprise legal person; public institution legal person

II. Basis

i. Article 15 of the Regulation on the Administration of Medical Institutions (Order No. 149 of the State Council issued on February 26, 1994, revised according to the Provisions of the State Council on the Amendment of Some Administration Regulations on February 6, 2016): A medical institution providing relevant services shall conduct registration and obtain the Practicing License for a Medical Institution;

ii. Chapter III of the Implementation Rules for the Regulation on the Administration of Medical Institutions (Order No. 35 of the Ministry of Health issued on August 29, 1994, effective on September 1, 1994, revised according to the notice of the Ministry of Health on Article 3 of the Implementation Rules for the Regulation on the Administration of Medical Institutions on November 1, 2016 and effective on April 1, 2017 according to the decision of the National Health and Family Planning Commission on the amendment of the Implementation Rules for the Regulation on the Administration of Medical Institutions on February 21, 2017);

iii. The Decision of the People’s Government of Hainan Province on Retaining, Adjusting and Canceling Administrative Licensing Items (Order No. 179 of the Hainan Provincial Government); implementing entity: Hainan Provincial Department of Health; licensing item: Practicing registration of medical institutions; and

iv. Notice on Further Reforming and Improving the Examination and Approval for Medical Institutions and Physicians (G.W.Y.F. [2018] No. 19, issued on June 19, 2018)

Excerpt of Article 5: “Two-in-one” license will be implemented for the examination and approval for the establishment and the practicing registration of Grade II and below medical institutions. Except for 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 institutions by service providers from Hong Kong, Macao and Taiwan regions, the health and wellness administrative departments will no longer approve and issue the Approval for the Establishment of Medical Institutions. Instead, only the Practicing License for a Medical Institution will be issued during the practicing registration process for other medical institutions.

III. Acceptance Conditions

To apply for practicing registration, a medical institution shall meet the following conditions: For medical institutions implementing the “two-in-one” license, an in-depth study on the feasibility of the establishment of the medical institution and its impact on the surrounding area shall be conducted prior to applying for practicing registration and matters such as the medical institution’s location layout, functional positioning, service modes, diagnosis and treatment items, personnel allocation, number of sickbeds and equipment and facilities shall be reasonably designed. i. It complies with the basic standards for medical institutions; ii. it has an appropriate name, organizing institution and premise; iii. it has funds, facilities and professional health technicians that are compatible with the business carried out; iv. it has corresponding rules and regulations; and v. it is able to independently assume civil liabilities. Where an applicant applying for practicing registration of a medical institution falls under one of the following circumstances, the authority shall disapprove its registration: i. It does not comply with the Basic Standards for Medical Institutions; ii. the business premise for the medical institution is unable to satisfy the needs of diagnosis and treatment services; iii. its public facilities such as communication, power supply, water supply and sewerage are unable to meet the normal operation of the medical institution; iv. the rules and regulations of the medical institution do not satisfy the requirements; v. its employees failed the on-site random inspection and examination on disinfection, isolation, aseptic operation and other basic knowledge and skills; and vi. 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 institutions by service providers from Hong Kong, Macao and Taiwan regions shall submit the Approval for the Establishment of Medical Institutions.

IV. Application Materials

Circumstance I. For the practicing registration of provincial medical institutions implementing “two-in-one” license, the following materials shall be submitted:

i. Application Form of a Medical Institution for Practicing Registration;

ii. The property certificate or the certificate on the use of the business premise of the medical institution (such as a housing rental certificate or rental contract);

iii. The plan for the architectural design of the medical institution;

iv. The rules and regulations of the medical institution;

v. The list of the medical institution’s legal representative or primary person in charge and the persons in charge of all departments, and the photocopies of relevant qualification certificates and practicing certificates;

vi. The status of the connection to the provincial regulatory platform for Internet-based medical services (this material shall be submitted if approval has been obtained to add Internet-based diagnosis and treatment into its services, designate the Internet hospital as its secondary name, or establish an Internet hospital. Otherwise, this material does not need to be submitted); and

vii. For delegated applications, a power of attorney and identity certificate of the operator shall be submitted.

Circumstance II. For the practicing registration of provincial medical institutions not implementing “two-in-one” license (including Grade III hospitals, Grade III maternal and child health care hospitals, emergency centers, first-aid stations, clinical testing centers, Chinese-foreign joint venture medical institutions, and wholly-owned medical institutions by service providers from Hong Kong, Macao and Taiwan regions), the following materials shall be submitted:

i. Application Form of a Medical Institution for Practicing Registration;

ii. The property certificate or the certificate on the use of the business premise of the medical institution (such as a housing rental certificate or rental contract);

iii. The plan for the architectural design of the medical institution;

iv. The rules and regulations of the medical institution;

v. The list of the medical institution’s legal representative or primary person in charge and the persons in charge of all departments, and the photocopies of relevant qualification certificates and practicing certificates;

vi. A written approval for the establishment of the medical institution;

vii. The status of the connection to the provincial regulatory platform for Internet-based medical services (this material shall be submitted if approval has been obtained to add Internet-based diagnosis and treatment services, designate the Internet hospital as its secondary name, or establish an Internet hospital. Otherwise, this material does not need to be submitted); and

viii. For delegated applications, a power of attorney and identity certificate of the operator shall be submitted.

V. Time Limits for Conclusion

Statutory time limit: 45 business days

Promised time limit: 15 business days

VI. Handling Results

Practicing License for a Medical Institution

VII. Charge Basis and Fee Rates

No charges

VIII. Handling Procedures

i. 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);

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

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

iv. 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/