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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II TECHNICAL SERVICES CHAPTER III SERVICE INSTITUTIONS CHAPTER IV TECHNICIANS CHAPTER V SUPERVISION AND ADMINISTRATION CHAPTER VI PENALTY PROVISIONS CHAPTER VII SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. These Detailed Rules are formulated in accordance with the Regulation on the Administration of Family Planning Technical Services (hereinafter referred to the Regulation). Article 2. The various institutions at all levels that engage in family planning technical services inside the territory of the People's Republic of China and their staff shall abide by the Regulation and these Detailed Rules. Article 3. Family planning technical services shall be provided pursuant to the principle of combining the guidance of the state with the willingness of individuals. A citizen shall be entitled to, when implementing family planning, know the results of his/her own health examination, the functional mechanism of usual methods of contraception and birth control, the indications, contraindications, advantages and disadvantages, usage, points for attention, possible side effects and countermeasures thereof. He/she shall also, under the guidance of the family planning technical service staff, conscientiously choose a suitable method of contraception and birth control. The institutions and persons who engage in family planning technical services shall, when providing contraception and birth control technical services, fully consider the health conditions, labor intensity and physiological period of the service recipients, guide citizens to choose suitable methods of contraception and birth control, and provide them with safe, effective and regularized technical services. The couples who have already had children shall be advised to mainly choose the long-term methods of contraception and birth control. Article 4. The state guarantees citizens' rights to receive suitable family planning technical services, and provides contraception and birth control technical services free of charge to rural couples at child-bearing age who are implementing the family planning policy. The technical service items provided free of charge shall include distribution of contraceptive drugs and devices; examination of the pregnant situation and IUD (intrauterine device) situation; placement and withdrawal of intrauterine devices and the various medical examinations prescribed in technical norms; artificial termination of pregnancy and the various medical examinations prescribed in technical norms; tubal ligation and vasectomy and the various medical examinations prescribed in technical norms; diagnosis and treatment of complications resulting from family planning operations. Article 5. The expenses needed in providing contraception and birth control technical services free of charge to rural couples at child-bearing age who are implementing the family planning policy shall be guaranteed by the treasuries at all levels by creating special funds for this purpose. The specific rates and forms of settlement shall be set forth by the people's government of each province, autonomous region, or municipality directly under the Central Government. The state distributes contraceptive drugs and devices free of charge to urban couples at child-bearing age who are implementing the family planning policy. If an urban couple at child-bearing age who are implementing the family planning policy accept the contraception and birth control technical services, the service fees shall be resolved through the following avenues: the service fees of those who have bought childbirth insurance, medical treatment insurance or other relevant social insurances shall be paid from the social insurance funds by way of overall arrangement; while the service fees of the citizens who have not bought any of the abovementioned insurances shall be borne by the respective entities where they work or be borne by the local treasuries. The specific measures shall be formulated by the local people's government at the county level or above. With respect to the expenses needed in providing contraception and birth control technical services to western depressed regions free of charge, the treasury of the Central Government shall provide adequate subsidies. Article 6. The State Family Planning Commission shall take charge of the work of administering family planning technical services throughout China, and perform the following duties: (1) Formulating rules in match with the Regulation; (2) Formulating the planning and norms on reproductive health care services by focusing on childbirth, birth control, and sterility, working out and publishing family planning technical service items as well as the catalogue of drugs and devices; (3) Formulating the national development planning on the work of family planning technical services, and guiding the planning, construction, administration and supervision of family planning technical service networks at all localities; (4) Organizing the formulation and implementation of the overall planning on scientific research relevant to the work of family planning technical services, organizing the spreading of new technologies of family planning and the monitoring of the on-market contraceptive drugs and devices; (5) Administering and supervising family planning technical services; and (6) Administering other work relevant to family planning technical services. Article 7. The planning on the family planning technical service network at each locality shall be proposed by the family planning administrative department of the local people's government at the county level or above under the uniform leadership of the local people's government in compliance with the principles of reasonable layout, proper scale and extensive coverage, and shall be reported to the people's government at the same level for incorporation into the planning on national economy, social development and regional sanitation. Article 8. An institution engaging in family planning technical services shall adhere to the working guidelines of "facing grass roots, going deep into the rural areas, providing doorstep services, and facilitating the general public". The various institutions engaging in family planning technical services at all levels shall divide their work duties in a reasonable way, cooperate with each other closely, and complement their advantages with each other, so as to jointly do a good job in contraception and birth control services and other reproductive health care services by focusing on childbirth, birth control and sterility. Article 9. The State Family Planning Commission shall make the overall planning on scientific research, technical development, introduction and spreading of new technologies regarding family planning, and organize the implementation of such overall planning. The family planning administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall take charge of organizing the implementation of the projects for promoting the scientific research, technical development, introduction and spreading of new technologies regarding high quality family planning services. Domestic and foreign enterprises, foundations, international organizations and social organizations may, in accordance with the Regulation and these Detailed Rules, apply for undertaking or participating in promoting the scientific research, technical development, introduction and spreading of new technologies relating to family planning technical services. CHAPTER II TECHNICAL SERVICES Article 10. Family planning technical services shall refer to the activities of purposefully providing childbirth control services and other relevant reproductive health care services to citizens at child-bearing age by means of operations, drugs, devices, apparatus, information and other technical means, including technical guidance and consulting on family planning, and clinical medical treatment services relevant to family planning. Article 11. The technical guidance and consulting on family planning shall include the following contents: (1) popular science dissemination, guidance and consulting on contraception, reduction of the risks of birth defects, and other reproductive health; (2) provision of contraceptive drugs and devices, and guidance, consulting and visits to the service recipients; and (3) provision of relevant guidance, consulting and visits prior to or after the operation of contraception and birth control or the operation of reversal of tubal ligation or vasectomy. Article 12. The clinical medical treatment services relevant to family planning shall include the following contents: (1) medical examinations of contraception and birth control, mainly referring to the pre-operation health examinations, the post-operation recovery examinations, and the examinations needed in guaranteeing safe and effective contraception, which are made pursuant to the technical norms on contraception and birth control for the purpose of eliminating the contraindications and knowing about the indications; (2) the diagnosis, authentication and treatment of various complications resulting from family planning operations, and adverse reactions of family planning drugs and devices, as well; (3) various operations of contraception and birth control, operations for recovering fertility such as reversal of tubal ligation or vasectomy, and the clinical medical diagnosis and treatment relevant to such operations; (4) other reproductive health care services focusing on childbirth, birth control and sterility which are provided in accordance with the relevant provisions jointly formulated by the State Family Planning Commission and the Ministry of Health; and (5) necessary examinations, observations, diagnosis and treatment activities in disabled child medical authentication. Article 13. Those who apply for medical authentication when requesting for giving birth to an additional child due to birth of disabled children shall be governed by the "Measures for the Administration of Disabled Child Medical Authentication". The medical authentication and diagnosis of disabled children and the guidance to the parents on giving birth to additional children shall be governed by the "Interim Standards for Medical Authentication and Diagnosis of Disabled Children and the Guiding Principles on Giving Birth to Additional Children". Article 14. The diagnosis, authentication and administration of complications resulting from family planning operations shall be governed by the "Measures for the Administration of Authentication Complications Resulting from Family Planning Operations". The medical malpractices which occur in family planning technical services shall be dealt with in accordance with the relevant legal provisions of the state. Article 15. To carry out a crowd-oriented family planning scientific and technical research project or international cooperation project in urban or rural grass roots, the project undertaking entity shall, in accordance with the legal provisions, propose a written application and its working scheme, which shall, upon consent after preliminary examination of the family planning administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government at the locality of implementation, be reported to the State Family Planning Commission for examination and approval, and for implementation thereafter. During the implementation, the project undertaking entity shall accept the supervision of the family planning administrative department of the local people's government at the county level or above at the locality where the project is implemented. Article 16. To publish an advertisement involving family planning technology, one must get the consent of the family planning administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government upon examination, and then report to the advertisement administrative department at the same level for approval. Article 17. A family planning technical service institution or medical treatment or health care institution engaging in family planning technical services at any level shall, when implementing an operation of contraception or birth control, a special examination or special treatment, make necessary explanations to the service recipient who implements the family planning, and obtain the consent of this service recipient. The special examination or special treatment shall mean a diagnosis and treatment activity under any of the following circumstances: (1) the examination or treatment having certain danger, which might cause any ill consequence; (2) the examination or treatment that might cause any ill consequence or danger to the service recipient due to his/her special physique or serious state of illness; (3) clinical trial examination or treatment; or (4) the examination or treatment for which fees shall be charged and which might cause heavy economic burden to the service recipient. Article 18. No institution engaging in family planning technical services and none of its family planning technical service staff members may carry out any fetus gender authentication which is not required by medical needs or carry out selective artificial termination of pregnancy. Those who are approved through authentication to give birth to an additional child due to birth of disabled children, and those whose fetuses are suspected to have sex-linked inherited diseases and are thus in need of gender authentication, shall be determined by the disabled child medical authentication team at the provincial level, and go to the designated institution for authentication in accordance with the relevant legal provisions. If, after authentication and diagnosis, they are required to implement artificial termination of pregnancy, they shall show the authentication opinions and resolving opinions of the disabled child medical authentication team at the provincial level. CHAPTER III SERVICE INSTITUTIONS Article 19. The institutions engaging in family planning technical services shall include the family planning technical service institutions and the medical treatment institutions and health care institutions engaging in family planning technical services. A family planning technical service institution shall refer to a non-profit welfare-oriented public institution that has obtained a practicing permit in accordance with the Regulation, is subordinated to the family planning administrative department at the same level, has the nature of medical treatment or health care, and engages in family planning technical services, and whose expenditures are fully allotted by the state. The expenditures of a family planning technical service institution at any level shall be guaranteed by the treasury at its corresponding level. A medical treatment or health care institution engaging in family planning technical services shall refer to a medical treatment or health care entity that holds a "Practicing Permit of the Medical Treatment Institution", has set up a section office of family planning technical services in accordance with the Regulation, and has obtained a practicing permit for certain family planning technical service items. Article 20. To establish an institution engaging in family planning technical services at the township level or above, the applicant must meet the standards formulated by the State Family Planning Commission for establishment of institutions. With regard to the standards for the establishment of family planning technical service institutions at the village level or urban community level and the procedures for examination and approval thereof, the family planning administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall propose a plan, and submit it first to the people's government at the same level for approval, and then to the State Family Planning Commission for archival filing. Article 21. The examination and approval of the establishment of family planning technical service institutions, and the examination, approval and verification of their practicing permits shall be handled pursuant to the principle of hierarchical jurisdiction. The family planning administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall take charge of the examination and approval of the establishment of family planning technical service institutions at the districted municipality level or above, and the examination, approval and verification of their practicing permits, as well; The family planning administrative department of a local people's government at the districted municipality level shall take charge of the examination and approval of the establishment of the family planning technical service institutions at the county or township level, and the examination, approval and verification of their practicing permits, as well; A family planning technical service institution that is approved to practice business shall be entitled to obtain a "Practicing Permit for the Family Planning Technical Service Institution", which shall state the family planning technical service items approved to be provided. Article 22. A family planning technical service institution at the township level may, in addition to providing technical guidance and consultation on family planning as prescribed in Article 7 of the Regulation, apply in accordance with the "Standards for Establishment of Institutions Engaging in Family Planning Technical Services" and the "Basic Standards for Appraisal of Family Planning Technical Service Items" for carrying out medical examination, placement or withdrawal of intrauterine devices, sterilization, artificial abortion for the purpose contraception and birth control, and for providing other clinical technical services relevant to contraception and birth control. It may not provide certain services until they have been examined and approved by the family planning administrative department of the local people's government at the districted municipality level item by item. No family planning technical service institution may unlawfully add any technical service item without approval. Article 23. Where a medical treatment or health care institution intends to provide family planning technical services, it shall, according to the standards for establishment as set forth by the State Family Planning Commission, establish a section office of family planning, which shall be subject to the examination and approval of the health administrative department of the local people's government at the county level or above, and shall indicate the approved service items on its practicing permit. Article 24. Where there are both a health center and a family planning technical service station in a township or town, they shall carry out the work of family planning technical services within their respective approved scopes. If there is already a health center in a township or town but there is no family planning technical service institution, no family planning technical service institution shall be further established, provided that the town or township health center must establish a section office of family planning technical services to specially engage in the work of family planning technical services, and shall accept the working guidance, supervision and administration of the health administrative department and the family planning administrative department at the higher level. If a town or township health center has established a section office of family planning technical services, but no one provides family planning technical services, or the services it provides cannot satisfy the demand in the family planning services, the matter shall be appropriately settled by the local township or town people's government, the health administrative department and the family planning administrative department of the local people's government at the county level. If there is neither a health center nor a family planning technical service institution in the township or town, a family planning technical service institution must be established. Article 25. Where a family planning technical service institution carries out the diagnosis and treatment operations other than the clinical medical treatment service items prescribed in the Regulation which are relevant to family planning, it shall, in accordance with the Regulation for the Administration of Medical Treatment Institutions, apply to the health administrative department for a "Practicing Permit of the Medical Treatment Institution", and accept the supervision and administration of the health administrative department. Article 26. Where a family planning technical service institution wishes to engage in prenatal diagnosis, it shall, after obtaining the consent of the family planning administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, report it to the health administrative department at the same level for examination and approval. The acceptance department shall make a decision within the prescribed time limit, notify the applicant entity in writing, and notify the family planning administrative department at the same level. If any permission decision is made, such a decision shall, within the prescribed time limit, report the approved entity to the Ministry of Health and the State Family Planning Commission for archival filing. Where an institution engaging in family planning technical services uses any auxiliary reproductive technology to treat sterility, it shall apply for providing services in accordance with the "Measures for the Administration of Treatment of Sterility with Assisted Reproductive Technologies" formulated by the Ministry of Health jointly with the State Family Planning Commission. The institutions and technicians approved to provide services of treatment of sterility with auxiliary reproductive technologies shall do so according to the technical norms on treatment of sterility with auxiliary reproductive technologies. Article 27. The establishment of family planning technical service institutions, and the granting and verification of their practicing permits shall be governed by the "Measures for the Administration Family Planning Technical Service Institutions' Practicing". To apply for the establishment of a new medical treatment or health care institution engaging in family planning technical services, the applicant shall file an application to the health administrative department at the county level or above, and shall, by analogy to the procedures prescribed in the Regulation for the Administration of Medical Treatment Institutions, obtain a letter of approval of the establishment and a practicing permit. The practicing permit shall indicate the technical service items approved to be provided. Article 28. Where an institution engaging in family planning technical services needs to modify its name, place of practice, legal representative or principal technical person-in-charge, it shall go to the original certificate issuing department to make modification registration. If it stops engaging in family planning technical services due to close-down or modifying its scope of business, it must make nullification registration in the original certificate issuing department, return its permit certificate, or nullify the corresponding family planning technical service items on its "Practicing Permit of the Medical Treatment Institution". The original certificate issuing department shall, within 30 working days as of receipt of the application for modification or nullification, make a decision and inform the applicant by letter. Where the practicing permit of an institution engaging in family planning technical services is lost, the institution shall, within 30 working days as of the day when it is aware of loss of its practicing permit, apply to the original certificate issuing organ for the issuance of a new one after publishing a pronouncement of loss on a local newspaper at the county level. If it fails to apply for the issuance of a new practicing permit, it shall be deemed to have no such permit. Article 29. An institution engaging in family planning technical services shall hang up its practicing permit, service items and fee charge rates on an eye-catching position. An institution engaging in family planning technical services shall consciously abide by the relevant laws and regulations, strictly implement the state-formulated medical treatment technical norms, family planning technical service rules and other relevant systems. Article 30. The members of the family planning technical service experts' committee shall be nominated by the family planning administrative department after consulting with the health administrative department at the same level, and be established after examination and approval of the people's government at the same level. The family planning technical service experts' committee shall be composed of the experts engaging in family planning technical services, relevant medical experts, as well as family planning and health administration experts, with its main duties as follows: (1) Participating in appraising the institutions engaging in family planning technical services; (2) Participating in organizing the examinations and assessments of family planning technical service staff members; (3) Guiding disabled child medical authentications, technical authentications on complications resulting from family planning operations, and other technical authentications relevant to family planning; (4) Assisting the local family planning administrative department in organizing scientific research projects related to family planning technical services, guiding the spreading and application of local new technologies of family planning, and providing guidance and trainings on family planning technical services; (5) Participating in the assessment and evaluation of the work of family planning technical services; (6) Making surveys on family planning technical services, and proposing opinions and suggestions regarding the administration and development of family planning technical services; and (7) Undertaking other tasks commissioned by the family planning administrative department. CHAPTER IV TECHNICIANS Article 31. A family planning technical service staff member shall refer to a person who has, in accordance with the Regulation and these Detailed Rules, obtained a "Conformity Certificate for Family Planning Technical Service Staff Member" (hereinafter referred to the Conformity Certificate), and engages in technical guidance and consultation on family planning, or clinical medical treatment services relevant to family planning in an institution engaging in family planning technical services. Article 32. Among the family planning technical service staff, those who engage in clinical services relevant to family planning in accordance with the Regulation shall, in accordance with the Law on Practicing Doctors and other provisions of the state for the administration of rural doctors, nurses and other health technicians, apply to the local health administrative department of the local people's government at the county level or above for registration. For those who have temporarily not attained to the requirements for the registration of practicing doctors, assistant practicing doctors, rural doctors or nurses but have engaged in the work of family planning technical services for 3 years or longer and have never caused any medical malpractice, and have obtained their conformity certificates issued by the State Family Planning Commission due to passing the post-related training, they may be recommended by the family planning administrative department of the local people's government at the county level or above to, upon consent of the family planning administrative department of the local people's government at the level of districted municipality in consultation with the health administrative department at the same level, be subject to postponement of the ascertainment of their practicing qualifications for 2 to 3 years commencing from October 1, 2001. The specific measures shall be formulated by the family planning administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government. Article 33. A system of obtaining a certificate before starting to work shall be adopted to the family planning technical service staff members. The various technicians engaging in family planning technical services shall pass corresponding professional trainings, be familiar with the relevant basic professional theoretical knowledge and the actual operation skills, have good knowledge of the national and local family planning policies, grasp the family planning technical criteria and service norms, obtain Conformity Certificates, and provide services pursuant to the items stated in the Conformity Certificate. The responsibilities to examine and approve, to verify and to administer the Conformity Certificates of the family planning technical service staff members who work for family planning technical service institutions or work for medical treatment or health care institutions engaging in family planning technical services shall remain separately with the family planning administrative department of the local people's government at the districted municipality level or above and the health administrative department of the local people's government at the county level or above. Article 34. The various family planning technical service staff members who intend to engage in the consultation, guidance, distribution of drugs and devices, operations or clinical examinations, etc, shall all apply for a Conformity Certificate. To apply for a Conformity Certificate, the applicant shall submit the following documents: (1) an application form filled out by the applicant for the conformity certificate for the family planning technical service staff member. Such an application form shall clearly indicate the category of the technical service items, and bear the examination opinions signed by the entity for which the applicant works, and the seal affixed thereby; (2) the proof documents on passing the examination on the basic population policy knowledge and family planning technologies, which is organized by the family planning administrative department of the local people's government at the districted municipality level or above, and on passing the assessment of operation skills, which is organized by the family planning administrative department of the local people's government at the county level or above; (3) diploma and proof document of the professional technical title; and (4) other materials required by the family planning administrative department of the local people's government at the districted municipality level or above or the health administrative department of the local people's government at the county level or above to be submitted. Article 35. Whoever has obtained the qualification for carrying out family planning operations before the Regulation comes into force and continues providing family planning technical services in an institution engaging in family planning technical services, shall apply for issuance of a new Conformity Certificate to replace the old one. The following documents shall be submitted when applying for the issuance of the new Conformity Certificate: (1) the conformity certificate for carrying out family planning operations, which was checked and issued by the family planning administrative department or health administrative department of the local people's government at the county level or above; (2) the application form for the conformity certificate of a family planning technical service staff member, which is filled out by the applicant and bears the examination opinions signed by the entity and the seal affixed thereby; (3) the documents proving that the applicant has neither caused any medical malpractice nor committed any act in violation of the family planning technical norms or occupational ethics within the latest 3 years; and (4) other materials required by the family planning administrative department of the local people's government at the districted municipality level or above or the health administrative department of the local people's government at the county level or above to be submitted. Article 36. To apply for the issuance of a Conformity Certificate, for the replacement of the old Conformity Certificate with a new one, or for examination and approval of a Conformity Certificate, the applicant shall indicate the technical service items. If the applicant is approved to provide operation services, the Conformity Certificate shall indicate the operation types. Where an institution that has obtained a Conformity Certificate requests for adding any technical service item or operation type, it must file an application to the original certificate issuing department. Article 37. The valid term of a Conformity Certificate shall be 3 years. The certificate holder shall, 3 months prior to the expiry of the valid term, bring the Conformity Certificate, the examination opinions of the entity, and the documents proving that he has neither caused any heavy medical malpractice nor committed any act in violation of the family planning technical norms or occupational ethics within the latest 3 years, to the original certificate issuing organ to have the certificate verified. A Conformity Certificate which has not been verified within the time limit shall be invalidated automatically. The department that accepts an application for issuance of a certificate, replacement of the old certificate with a new one, or verification of a certificate shall make a decision within 30 working days as of receipt of the application, and notify the applicant. Article 38. The family planning administrative department or the health administrative department of the local people's government at the county level or above shall draft a planning, organize the implementation of the professional trainings and continuing medical education for its family planning technical service staff, continuously improve the working capacities and technical level of the family planning technical service staff. The records on practice-related trainings and continuing education received by a doctor in a family planning technical service institution may be deemed as the basis for assessment of his practice and determination of his professional technical title. CHAPTER V SUPERVISION AND ADMINISTRATION Article 39. The State Family Planning Commission shall take charge of the supervision and administration of the work of family planning technical services throughout China, and perform the following supervisory and administrative duties: (1) Inspecting, supervising and guiding the implementation of the Regulation, these Detailed Rules and other auxiliary documents; (2) Supervising and inspecting the statistical work of family planning technical services, and taking charge of organizing the gathering and analysis of national statistical data on family planning technical services and the publishing of the results; (3) Taking charge of gathering, analyzing and publishing the information on malpractices, complications and adverse reactions resulting from family planning technical services throughout China, and guiding the investigation and settlement of ill incidents; and (4) Supervising and administering other matters on the family planning technical services throughout China. Article 40. The family planning administrative department of a local people's government at the county level or above shall take charge of supervising and administering the family planning technical services within its own jurisdiction, and perform the following supervisory and administrative duties: (1) Taking charge of proposing the planning on the family planning technical service network within its own jurisdiction, and undertaking the specific construction and management tasks after the planning has been approved by the people's government at the same level; (2) Taking charge of granting, registering and verifying the practicing permits of the family planning technical service institutions and their staff within its own jurisdiction; (3) Inspecting and supervising the implementation of the Regulation and these Detailed Rules by the institutions engaging in family planning technical services within its own jurisdiction and their staff; (4) Taking charge of the statistical work of family planning technical services within its own jurisdiction; (5) Investigating and settling the malpractices, complications and adverse reactions arising out of family planning technical services within its own jurisdiction; (6) Taking charge of the disabled child medical authentication and the management of complications resulting from family planning operations; (7) Supervising and administering the crowd-oriented family planning scientific and technological projects and international cooperation projects carried out within its own jurisdiction; (8) Giving administrative penalties in accordance with the law against the acts in violation of the Regulation and these Detailed Rules; and (9) Taking charge of other matters for supervision and administration of the family planning technical services within its own jurisdiction. Article 41. The family planning administrative department of a local people's government at the county level or above shall have technical managers and law enforcement supervisors, who shall have the diploma of the relevant major and have passed the trainings on law enforcement and administration of family planning technologies, and shall legally perform the duties of administration and law enforcement supervision of family planning technical services. Article 42. The law enforcement supervisors of family planning technical services shall show their certificates when performing their duties. The law enforcement supervisors of family planning technical services may inquire about facts from the institutions engaging in family planning technical services, ask for necessary documents, investigate on and collect evidence from the relevant persons, and inspect and supervise the work of family planning technical services. The institution engaging in family planning technical services and other relevant persons may neither refuse to provide nor conceal the abovementioned information. The law enforcement supervisors of family planning technical services shall be obligated to keep confidential for the information provided by the institutions engaging in family planning technical services and the relevant persons. Article 43. The family planning administrative department of a local people's government at the county level or above shall establish the system of supervisors of family planning technical services, retain family planning technical experts, scientific and technological management experts and drug test experts to inspect the implementation of the Regulation and these Detailed Rules by the institutions engaging in family planning technical services at the present level and their staff, and make a timely report to the family planning administrative department. Article 44. The family planning administrative department of the local people's government at the county level or above shall organize the inspection of family planning technical services at least once a year. The main contents of inspection shall include: the implementation of the Regulation and these Detailed Rules by the institutions engaging in family planning technical services at the present level or below, the implementation of the family planning technical standards and service norms, the technical service quality, and the application of family planning technologies, drugs and devices. Article 45. The family planning administrative department of a local people's government at the county level or above shall legally accept the tip-offs and complaints made by the institutions and individuals within its own jurisdiction about the quality of, malpractices and adverse reactions resulting from the sold family planning drugs, devices and relevant products, as well as the quality of and the malpractices resulting from the family planning technical services provided by the institutions engaging in family planning technical services within its own jurisdiction. The said administrative department shall also record down such tip-offs and complaints, and settle the matters in time jointly with the relevant department. Article 46. An institution engaging in family planning technical services must, pursuant to the rules formulated by the State Family Planning Commission on making statistics of family planning technical services, and the rules on reporting technical service malpractices, complications resulting from family planning operations, adverse reactions to family planning drugs and devices, truthfully make reports about the family planning technical service statistical data, malpractices, complications, and adverse reactions to drugs and devices to the local family planning administrative department and the health administrative department of the local people's government at the county level or above. The health administrative department of the local people's government at the county level or above shall, by November 1 each year, circularize the statistical data on the work of family planning technical services provided by the medical treatment and health care institutions engaging in family planning technical services to the family planning administrative department at the same level. Article 47. The State Family Planning Commission shall, jointly with the Ministry of Health, gather, analyze and circularize each year the data on malpractices of family planning technical services, complications resulting from operations, and adverse reactions to drugs and devices, and circularize the gathering and analysis results of adverse reactions to drugs and devices to the State Drug Administration. The family planning administrative department of the people's government of each province, autonomous region, or municipality directly under the Central Government shall, jointly with the health administrative department at the same level, gather and analyze the data on the malpractices, complications resulting from operations, and adverse reactions to drugs and devices that occur in the work of family planning technical services within its own area, and timely report to the State Family Planning Commission and the Ministry of Health. CHAPTER VI PENALTY PROVISIONS Article 48. Any institution that has not obtained a practicing permit but unlawfully engages in family planning technical services shall be penalized in accordance with Article 31 of the Regulation. Where any family planning technical service institution violates these Detailed Rules by employing any person having not legally obtained a Conformity Certificate to provide family planning technical services, it shall be ordered by the family planning administrative department of the local people's government at the county level or above to make a correction, and its illegal proceeds shall be confiscated. If the illegal proceeds are 1000 Yuan or more, it shall be fined one up to three times the illegal proceeds, in addition. While if there are no illegal proceeds or the illegal proceeds are less than 1000 Yuan, it shall be fined 1000 Yuan up to 3000 Yuan, in addition. Article 49. Where any institution engaging in family planning technical services or any of its staff members violates the Regulation by unlawfully engaging in prenatal diagnosis or by using any auxiliary reproductive technology to treat sterility without approval, it/he shall be penalized by the health administrative department of the local people's government at the county level or above jointly with the family planning administrative department at the same level in accordance with Article 32 of the Regulation. Article 50. Whoever trades in, lends, leases, alters or forges any practicing permit for family planning technical services shall be penalized by the original certificate issuing department in accordance with Article 34 of the Regulation. Whoever trades in, lends, leases, alters or forges any conformity certificate for any family planning technical service staff member shall be ordered by the original certificate issuing department to make a correction, and the illegal proceeds, if any, shall be confiscated. If the illegal proceeds are 1000 Yuan or more, it/he shall be fined twice up to five times the illegal proceeds, in addition. While if there are no illegal proceeds or the illegal proceeds are less than 1000 Yuan, it/he shall be fined 1000 Yuan up to 3000 Yuan, in addition. If the circumstance is serious, its/his relevant practicing qualification certificate shall be revoked by the original certificate issuing department. Article 51. Where anyone providing contraception and birth control technical services to rural couples at child-bearing age who implement the family planning charges any fee for the prescribed free service items, it shall be penalized by the family planning administrative department of the local people's government at the county level or above in accordance with Article 35 of the Regulation. Article 52. Where a person engaging in family planning technical services violates the Regulation or these Detailed Rules by unlawfully adding any family planning technical service item or by engaging family planning technical services without using the name of the institution where he practices the business, he shall be ordered by the original certificate issuing department to make a correction, be admonished, and his illegal proceeds shall be confiscated. If the illegal proceeds are 1000 Yuan or more, he shall be fined twice up to five times the illegal proceeds, in addition. While if there are no illegal proceeds or the illegal proceeds are less than 1000 Yuan, he shall be fined 1000 Yuan up to 3000 Yuan, in addition. If the circumstance is serious, his practicing qualification shall be revoked by the original certificate issuing department. Article 53. Where a family planning technical service institution or a medical treatment or health care institution engaging in family planning technical services issues any false proof document or makes a false operation when providing family planning technical services, it shall be penalized by the original certificate issuing department in accordance with Article 39 of the Regulation. Where any person engaging in family planning technical services commits either of the abovementioned acts, he shall be ordered by the original certificate issuing department to make a correction and be admonished, and his illegal proceeds shall be confiscated. If the illegal proceeds are 1000 Yuan or more, he shall be fined twice up to five times the illegal proceeds, in addition. While if there are no illegal proceeds or the illegal proceeds are less than 1000 Yuan, he shall be fined 1000 Yuan up to 3000 Yuan, in addition. If the circumstance is serious, his relevant practicing qualification certificate shall be revoked by the original certificate issuing department. Article 54. Where a party concerned is dissatisfied with an administrative penalty decision, it/he may legally apply for administrative reconsideration or bring an administrative lawsuit. If, within the time limit, it/he neither applies for administrative reconsideration or brings an administrative lawsuit nor performs the administrative penalty decision, the organ making such an administrative penalty decision may apply to the people's court for compulsory enforcement. CHAPTER VII SUPPLEMENTARY PROVISIONS Article 55. The Practicing Permits for Institutions of Family Planning Technical Services as involved in the Regulation and these Detailed Rules shall be uniformly printed and produced by the State Family Planning Commission. As for the Conformity Certificates for Family Planning Technical Service Staff, a uniform specimen shall be set forth by the State Family Planning Commission, and the certificates shall be printed and produced by the family planning administrative department of the people's government of each province, autonomous region, or municipality directly under the Central Government. Article 56. These Detailed Rules shall come into force on the date of promulgation. |
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