Chapter I  General Provisions

Article 1 For the purpose of further carrying out the Overall Plan of China (Shanghai) Pilot Free Trade Zone distributed by the State Council, and in accordance with the Law of the People’s Republic of China on Enterprises with Foreign Investment, the Decision of National People’s Congress on Authorizing the State Council to Temporarily Adjust Administrative Examination and Approval under Relevant Laws in the China (Shanghai) Pilot Free Trade Zone, and the Regulations of Administration of Medical Institutions, Procedures of Shanghai Municipality for Administration of Medical Institutions, Procedures for Administration of China (Shanghai) Pilot Free Trade Zone and other relevant laws,  rules and regulations, these Interim Procedures are formulated.

Article 2 Wholly-foreign-funded medical institutions in the Interim Procedures mean medical institutions, companies, enterprises and other economic organizations with foreign medical institutions as their actual holder of the controlling share (hereinafter referred to as foreign investors) that establish profit-making medical institutions with sole foreign investment in the China (Shanghai) Pilot Free Trade Zone (hereinafter referred to as the PTRZ) with the approval of the competent department of the Chinese government.

Article 3 These Interim Procedures apply to the establishment and administration of wholly-foreign-funded medical institutions in the PFTZ.

Article 4 The wholly-foreign-funded medical institution shall observe relevant laws, rules and regulations. Its proper operation activity and legitimate rights and interests are guaranteed by the Chinese laws.

Article 5 The PFTZ administrative committee, Shanghai municipal departments of health and family planning, and of industry and commerce are responsible, within their respective duty, for the administration of wholly-foreign-funded medical institutions in the PFTZ.

The PFTZ industrial and commercial department is the register agency for wholly-foreign-funded medical institutions.

Chapter II  Conditions for Establishment

Article 6 The establishment and development of wholly-foreign-funded medical institutions shall comply with the related spirit and requirement for promoting the establishment of medical institutions by social forces in the planning of Shanghai Municipality for regional health and establishment of medical institutions, and shall exercise the Basic Standards of Medical Institutions formulated by the National Health and Family Planning Department.

Article 7 A foreign investor who intends to apply for setting up a wholly-foreign-funded medical institution shall be a legal person able to bear civil liability independently, having experience in direct engagement in medical institution investment and management for over five years and complying with one of the following requirements:

1. be able to provide international advanced administrative experience, management model and service model of medical institution;

2. be able to provide medical technology and equipment with international leading level; and

3. be likely to fill up the deficiency in the aspects of local medical service capability, medical quality, technology, fund and facilities.

Article 8 The establishment of a wholly-foreign-funded medical institution shall comply with the following requirements:

1. independent legal person;

2. the minimum total investment of RMB 20 million yuan; and

3. twenty years of operation period.

　　          Chapter III  Establishment Examination and Registration

Article 9 For the establishment of a wholly-foreign-funded medical institution, the following materials shall be submitted to the industrial and commercial department in the PFTZ according to the “one-window acceptance” working mechanism:

1. application materials for institution establishment ;

2. the project proposal and feasibility study report;

3. a register certificate (copy) of the foreign investor, ID of legal representative (copy) and bank credit statement;

4. the report of site selection, document of land-use lease and building plan;

5. certification of the foreign investor’s experience in direct engagement in medical institution investment and management for over five years;

6. articles of association of the wholly-foreign-funded medical institution;

7. a list of board members of the wholly-foreign-funded medical institution;

8. the notice of pre-approval of institution designation;

9. application materials for registration of enterprise establishment; and

10. other materials as may be prescribed by laws and regulations.

Article 10 If application materials are complete, the industrial and commercial department in the PFTZ shall issue a receipt thereof to the applicant and, within 40 workdays after the issuance of acceptance receipt, the municipal health and family planning department, the PFTZ administrative committee and the PFTZ industrial and commercial department shall issue a document of approval or disapproval. In the case of approval, the PFTZ industrial and commercial department shall serve in a unified way on the applicant the relevant documents such as the Letter of Approval of Medical Institution Establishment, the Certificate of Approval of Foreign-funded Enterprise and the Enterprise Business License.

Article 11 A wholly-foreign-funded medical institution established with approval shall, according to the procedure and requirement for registration of medical institution practice under the Regulations on Administration of Medical Institutions and the implementation rules thereof, apply for practice registration to the municipal health and family planning department and draw the License for Medical Institution Practice.

Article 12 The designation of a wholly-foreign-funded medical institution shall comply with the Implementation Rules of Medical Institution Administration Regulations, the Regulations on Administration of Enterprise Designation Registration, the Implementation Procedures for Administration of Enterprise Designation Registration and other relevant provisions.

　             Chapter IV  Alteration, Extension and Termination

Article 13 A wholly-foreign-funded medical institution established shall, within the prescribed time limit, complete the formalities for practice registration; if failing to do so, the project shall be cancelled with approval of the original examination agency.

Article 14 A wholly-foreign-funded medical institution established, if changing the institution address, bed scale, medical treatment items, operation term, total investment amount or the investor, shall make application to the original examination agency.

Article 15 A wholly-foreign-funded medical institution established, if putting an end to operation, shall apply to the original examination agency 90 days before termination of operation.

Article 16 A wholly-foreign-funded medical institution in need of extension after the expiration of operation shall apply to the original examination agency 180 days before the expiration.

　　                         Chapter V  Practice

Article 17 As an independent legal entity, the wholly-foreign-funded medical institution assumes responsibility for their own profits and losses and for independent accounting, and bears civil liability independently.

Article 18 A wholly-foreign-funded medical institution shall exercise relevant provisions on medical institution practice under the Regulations on Administration of Medical Institution and the Implementation Rules of Medical Institution Administration Regulations.

Article 19 A wholly-foreign-funded medical institution shall exercise the medical technology access norm and the clinic treatment technology code, observe relevant provisions on new technology, new equipment and clinical application of large medical equipment.

Article 20 Medical errors made by the wholly-foreign-funded medical institution shall be handled according to relevant laws and regulations.

Article 21 A wholly-foreign-funded medical institution shall employ medical personnel according to relevant laws, rules and provisions.

Article 22 A wholly-foreign-funded medical institution shall strictly exercise the system of disinfection and isolation, take scientific, effective measures of handling sewage and wastes to prevent and reduce hospital infection, and strictly observe provisions on radiotherapy.

Article 23 In the case of major disaster, accident, epidemic disease or other emergency, a wholly-foreign-funded medical institution and its health technicians shall be ready to accept an assignment by the health and family planning department.

Article 24 A wholly-foreign-funded medical institution shall publish its medical advertisements according to the Advertising Law of the People’s Republic of China, the Procedures for Medical Advertisement Administration and other relevant laws and rules.

Article 25 A wholly-foreign-funded medical institution shall set its charges for medical service under the relevant provisions of the State.

Article 26 A wholly-foreign-funded medical institution shall pay taxes according to relevant provisions of the State and the PFTZ.

　　                       Chapter VI  Supervision

Article 27 The health and family planning department in the district where the PFTZ is located shall be responsible for routine supervision over wholly-foreign-funded medical institutions in the PFTZ.

The municipal health and family planning department shall be responsible for supervisory administration of wholly-foreign-funded medical institutions and verification of medical institutions, verifying wholly-foreign-funded medical institutions once a year.

Article 28 A wholly-foreign-funded medical institution shall accept supervision by the related State department under the relevant State provisions on foreign-funded enterprises.

Article 29 A wholly-foreign-funded medical institution, if contravening relevant laws, rules or regulations, shall be investigated and dealt with according to law by the relevant competent department. For contravention of these Interim Procedures, the wholly-foreign-funded medical institution shall be punished according to relevant laws, rules and regulations by the PFTZ administrative committee, the health and family planning departments and industrial and commercial departments of Shanghai Municipality and the district where the PFTZ is located.

Article 30 If the PFTZ administrative committee, the health and family planning departments and industrial and commercial departments of Shanghai Municipality and the district where the PFTZ is located arbitrarily approve the establishment and alteration of a wholly-foreign-funded medical institution in contravention of these Interim Procedures, the relevant persons-in-charge shall be investigated for responsibility according to law.

A foreign investor who sets up a wholly-foreign-funded medical institution and conducts medical activity or deals in medical treatment items in the form of contract without approval of the PFTZ administrative committee, the health and family planning departments and industrial and commercial departments of Shanghai Municipality and the district where the PFTZ is located shall be deemed to practice medicine illegally and shall be punished according to the Regulations on Administration of Medical Institution and the Implementation Rules of Medical Institution Administration Regulations and other relevant provisions.

　　              Chapter VII  Supplementary Provisions

Article 31 Investors from Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan region who make investment in wholly-funded medical institutions in the PFTZ shall take reference to the Interim Procedures.

Article 32 Where any former regulations of this Municipality do not comply with the Interim Procedures, the Interim Procedures shall prevail.

Article 33 The Interim Procedures come into force on the date of distribution.

Shanghai Municipal Commission of Health and Family Planning　　

Shanghai Municipal Commission of Commerce　　

Shanghai Municipal Administration for Industry and Commerce　　

October 24, 2013