Circular No. 30 2015 TT-BYT of the Ministry of Health on import of medical equipment

MINISTRY OF HEALTH SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness - No.: 50/2016/TT-BYT Hanoi, December 30, 2016 CIRCULAR REGULATIONS ON MAXIMUM RESIDUE LEVELS OF PESTICIDE IN FOOD Pursuant to the Law on food safety dated June 17, 2010; Pursuant to the Government's Decree No 38/2012/ND-CP dated April 25, 2012 detailing the implementation of some articles of the Law of food safety; Pursuant to the Government's Decree No 63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of Ministry of Health; At the request of Director of Vietnam Food Administration; Minister of Health promulgates Circular introducing regulations on maximum residue levels of pesticide in food Article Scope and regulated entities This Circular deals with the maximum residue levels of pesticide in domestically produced foods and imported ones This Circular applies to producers and traders of foods, and authorities and entities involved Article Interpretation of terms In this document, these terms are construed as follows: Maximum Residue Level (“MRL” for short) refers to the highest concentration of a pesticide residue in a food (unit: mg/kg of food) Pesticide residue refers to any specified substance in food resulting from the use of a pesticide The term "pesticide residue" includes residues from unknown or unavoidable sources (e.g., environmental) as well as known uses of the chemical It includes any derivatives of a pesticide, such as conversion products, metabolites, reaction products, and impurities considered to be of toxicological significance Extraneous Maximum Residue Limit (“EMRL” for short) refers to the maximum concentration of a pesticide residue or a contaminant in food arising from environmental sources (including former uses of chemicals in agriculture), exclusive of the residue arising from the use of a pesticide or contaminant substance directly or indirectly on food (unit: mg/kg of food) 4 Acceptable Daily Intake (“ADI” for short) is the daily intake of a chemical which, during an entire lifetime, appears to be without appreciable risk to the health of the consumer (unit: mg/kg of the body weight) Pesticide Code (“Code” for short) means the code of a pesticide used by the Codex Alimentarius Commission (CODEX) Article Announcement of MRLs in food MRLs in foods are regulated in the Appendix enclosed to this Circular Article Implementation This Circular takes effect as of July 01, 2017 Part “Maximum Residue Levels of Pesticide in Food" promulgated under Decision No 46/2007/QD-BYT dated December 19, 2007 by Minister of Health on “Regulations on maximum levels of biological and chemical contaminants in food” shall be null and void as from the entry into force of this Circular The Vietnam Food Administration shall take charge and coordinate with relevant competent authorities in organizing the implementation of this Circular Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health Công ty Luật Minh Gia www.luatminhgia.com.vn THE MINISTRY OF HEALTH Circular No 30/2015/TT-BYT dated October 12, 2015 of the Ministry of Health on import of medical equipment Pursuant to the Commercial Law dated 14/6/2005; Pursuant to Decree No 187/2013/ND-CP dated 20/11/2013 of the Government detailing the implementation of Commercial Law on trading of international goods and activities of trading and processing agents and goods transit with foreign countries; Pursuant to Decree No 63/2012/ND-CP dated 31/08/2012 of the Government defining functions, duties, powers and organizational structure of the Ministry of Health; At the request of the Director of Department of Medical Equipment and Health Facilities; The Minister of Health issues the Circular providing for the import of medical equipment Chapter I GENERAL PROVISIONS Article Scope of regulation This Circular defines the authority, dossier and procedures for issue of import Permit of 100% brand new medical equipment (hereafter referred to as the import Permit) included in the List specified in Annex issued with this Circular The import of medical equipment in the form of foreign aid (including medical equipment of over 80% quality), temporary import and re-export, temporary export and re-import, border transfer of goods, medical equipment as movable property, in service of personal needs with diplomatic status and personal luggage shall comply with the provisions of Decree No 187/2013/NDCP dated 20/11/2013 of the Government detailing the implementation of the Commercial Law on trading of international goods and activities of trading and processing agents and goods transit with foreign countries and the guidelines of the Ministry of Industry and Trade Article Interpretation of terms In this Circular, the terms below are construed as follows: LUẬT SƯ TƯ VẤN PHÁP LUẬT 24/7: 1900 6169 Công ty Luật Minh Gia www.luatminhgia.com.vn Medical equipment is the types of equipment, tool, material and in-vitro diagnosis chemical and software used separately or combined with each other as indicated by the owner to serve people for one or a lot of purposes as follows: a) Diagnosis, prevention, monitoring, treatment and mitigation of disease or injury compensation; b) Checking, replacement, modification or surgery support and physiological process; c) Life support or sustainment; d) Kiểm soát thụ thai Conception control; dd) Sterilization of medical equipment (not including chemicals and insecticides and disinfectants for domestic and medical use); e) Use for medical equipment; g) Special transport for medical activities In-vitro diagnostic chemical includes the reagent, diagnostic chemical, cleaning solution used for medical equipment (in-vitro diagnostic biologicals excluded) Manufacturer is the unit carries out the design, production, assembly, packaging and labeling the medical equipment before provided Distributor is any organization or individual in foreign countries authorized by the owner to distribute n the medical equipment Medical equipment owner (hereafter referred to as owner) is any organization or individual directly implementing or permitting other organizations or individuals to use his/her name to provide the medical equipment in his/her own name or any label, design, commercial name or other names or other codes under the ownership or control of such organizations or individuals and shall take responsibility for the design, production, assembly, label, packaging, or maintenance, repair of medical equipment or define a purpose of use for such medical equipment Article Principles for issue of import Permit The issue of medical equipment import Permit only applies to the imported medical equipment included in the List specified in Annex issued with this Circular The medical equipment not included in the List specified in Annex issued with this Circular shall be imported without the import Permit but must still LUẬT SƯ TƯ VẤN PHÁP LUẬT 24/7: 1900 6169 Công ty Luật Minh Gia www.luatminhgia.com.vn ensure the dossier to trace their origin and quality management of medical equipment as prescribed by law Chapter II AUTHORITY, DOSSIER AND PROCEDURE FOR NEW ISSUE, RENEWAL, MODIFICATION, RE-ISSUE AND REVOCATION OF MEDICAL EQUIPMENT IMPORT PERMIT Article Authority of new issue, renewal, modification, re-issue and revocation of medical equipment import Permit The Minister of Health shall decide the new issue, renewal, modification, reissue and revocation of medical equipment import Permit Điều Các hình thức cấp giấy phép nhập trang thiết bị y tế Article Forms of issue of medical equipment import Permit The new issue of medical equipment import Permit is applied in case such medical equipment is requested for issue of medical equipment import Permit for the first time or the medical equipment import Permit has expired without renewal as stipulated in Clause 1, Article 13 of this Circular The renewal of medical equipment import Permit is applied in case the medical ...THE STATE BANK OF VIETNAM - SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness - No 38/2016/TT-NHNN Hanoi, December 30, 2016 CIRCULAR ON METHODS OF CALCULATING AND ACCOUNTING OF REVENUES AND PAYMENTS OF INTERESTS IN DEPOSITING AND LENDING OPERATIONS BETWEEN THE STATE BANK OF VIETNAM AND CREDIT INSTITUTIONS AND OTHER ORGANIZATIONS Pursuant to the Civil Code No 91/2015/QH13 dated November 24, 2015; Pursuant to the Law on the State bank of Vietnam No 46/2010/QH12 dated June 16, 2010; Pursuant to the Law on credit institutions No 47/2010/QH12 dated June 16, 2010; Pursuant to the Law on Accounting No 88/2015/QH13 on dated November 20, 2015; Pursuant to the Government's Decree No 156/2013/ND-CP dated November 11, 2013 defining the functions, tasks, entitlements and organizational structure of the State bank of Vietnam; Pursuant to Decision No 08/2013/QĐ-TTg dated January 24, 2013 of the Prime Minister on accounting regulations applicable to the State Bank of Vietnam; At the request of the Director of Department of Finance and Accounting; The Governor of the State bank of Vietnam promulgates a Circular on methods of calculating and accounting of revenues and payment of interests in depositing and lending operations between the state bank of Vietnam and credit institutions and other organizations Chapter I GENERAL PROVISIONS Article Scope This Circular deals with: Methods of calculating and accounting of payments of interests on required reserve deposits and excess reserve deposits of credit institutions, branches of foreign banks; deposits of other organizations at the State Bank of Vietnam; Methods of calculating and accounting of revenues of interests on loans made between the State Bank of Vietnam and credit institutions or branches of foreign banks Article Regulated entities The State Bank of Vietnam (hereinafter referred to as the State Bank) 2 Credit institutions, branches of foreign banks prescribed in the Law on credit institutions (hereinafter referred to as credit institutions) Other organizations other than credit institutions that are eligible for making deposits at the State Bank as prescribed by law (hereinafter referred to as other organizations) Article Interpretation of terms For the purposes of this Circular, the terms below shall be construed as follows: Deposits of credit institutions include required reserve deposits, excess reserve deposits of credit institutions at the State Bank Deposits of other organizations mean deposits of other organizations at the State Bank Interest means a sum that a credit institution pays the State Bank for using a sum of loan or a sum that the State Bank pays a credit institution or another organization for receiving a sum of deposit Deposit balance eligible for interest (of credit institution) means deposit balance in excess of reserve THE STATE BANK OF VIETNAM - THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness - No 41/2016/TT-NHNN Hanoi, December 30, 2016 CIRCULAR PRESCRIBING THE CAPITAL ADEQUACY RATIO FOR OPERATIONS OF BANKS AND/OR FOREIGN BANK BRANCHES Pursuant to the Law on the State Bank of Vietnam No.46/2010/QH12 dated June 16, 2010; Pursuant to the Law on Credit Institutions No 47/2010/QH12 dated June 16, 2010; Pursuant to the Government's Decree No 156/2013/ND-CP dated November 11, 2013 on defining the functions, tasks, entitlements and organizational structure of the State Bank of Vietnam; At the request of the Chief of Banking Inspection and Supervision Department; The State Bank’s Governor hereby introduces the Circular prescribing prudential ratios for operations of banks and/or foreign bank branches Chapter I GENERAL PROVISIONS Article Scope and subjects of application This Circular deals with the capital adequacy ratio for operations of banks and/or foreign bank branches in Vietnam Subjects of application encompass: a) Banks: State-owned commercial banks, joint-stock commercial banks, joint-venture banks and/or wholly foreign-owned banks; b) Branches of foreign banks This Circular shall not apply to banks put under special control Article Interpretation of terms For the purposes of this Circular, the terms used herein is construed as follows: Financial asset refers to any asset that is: a) Cash; b) An equity instrument of another entity; c) Contractual right: (i) to receive cash or another financial asset from another entity; or (ii) to exchange financial assets or financial liabilities with another entity under conditions that are potentially favorable to banks and/or foreign bank branches; d) a contract that will or may be settled in own equity instruments of banks Financial liability refers to any of the following contractual obligations: a) which is statutory: (i) to deliver cash or another financial asset from another entity; (ii) to exchange financial assets or financial liabilities with another entity under conditions that are unfavorable to banks and/or foreign bank branches; or b) a contract that will or may be settled in own equity instruments of banks Financial instrument refers to a contract that gives rise to a financial asset of one entity and a financial liability or equity instrument of another entity Equity instrument refers to any contract that evidences a residual interest in the assets of an entity after deducting all of its liabilities Equity instrument with characteristics of liability issued by a bank encompasses preferred dividend stocks and other equity instruments which: a) are redeemable in accordance with laws and ensure compliance with prudential limits or ratios after implementation as stated by laws; b) may be used to offset losses without requiring a bank incurring such losses to cease its proprietary trading transactions; c) are not subject to payment of preferred dividends and carry preferred dividends over to the next year in the event that such payment of preferred dividends results in losses in an income statement of a bank Subordinated debt refers to a debt that a creditor accepts an agreement to pay after other obligations are discharged, or for which a creditor gets and does not get other guarantees in case of the MINISTRY OF INDUSTRY AND TRADE SOCIALIST REPUBLIC OF VIET NAM Independence-Freedom-Happiness - No.: 36/2016/TT-BCT Hanoi, December 28, 2016 CIRCULAR ON ENERGY LABELING FOR MEANS AND EQUIPMENT USING ENERGY UNDER MANAGEMENT OF THE MINISTRY OF INDUSTRY AND TRADE Pursuant to the Government's Decree No 95/2012/ND-CP dated November 12, 2012, defining the functions, tasks, powers and organizational structure of the Ministry of Industry and Trade; Pursuant to the Law on economical and efficient use of energy dated June 28, 2010; Pursuant to the Decree No.21/2011/ND-CP dated March 29, 2011 detailing and taking measures for implementation of the Law on economical and efficient use of energy; Pursuant to the Law on Technical regulations and standards dated June 29, 2006; Pursuant to the Law on Product and goods quality dated November 21, 2007; Pursuant to the Government's Decree No 107/2016/ND-CP July 1, 2016 on conditions for provision of conformity assessment services; At the request of Director of General Department of Energy; The Minister of Industry and Trade promulgates a Circular on energy labeling for means and equipment using energy under management of the Ministry of Industry and Trade Chapter I GENERAL PROVISIONS Article Scope This Circular provides for procedures for registration, energy labeling and revocation of energy labels for means and equipment on the List of means and equipment required for energy labeling issued by the Prime Minister under management of the Ministry of Industry and Trade or other means and equipment carrying voluntary energy labels (hereinafter referred to as means and equipment) This Circular shall not apply to the following means and equipment using energy: a) Temporarily imported goods, means and equipment; goods in transit, transited goods; b) Goods produced and processed by domestic enterprises for the purpose of export (not for domestic consumption); c) Goods in the fields of national defense and security, national secret, radiation safety; d) Non-commercial imported goods: Personal baggage, diplomatic cargo; goods displayed in exhibits or fairs; gifts; goods, spare parts, components imported in single unit for the purposes of use or replacement in facilities, investment projects, or those serving conferences, seminars of scientific research, sport competitions, cultural performances, art performances and other types of goods not for business purposes in accordance with regulations of law Article Regulated entities This Circular shall apply to: Manufacturers or importers (hereinafter referred to as enterprises) of means and equipment with energy labels The testing laboratories participating in testing means and equipment with energy labels Agencies THE MINISTRY OF FINANCE - THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness - No 250/2016/TT-BTC Hanoi, November 11, 2016 CIRCULAR PROVIDING GUIDANCE ON FEES AND CHARGES WITHIN THE JURISDICTION OF THE PEOPLE’S COUNCIL OF CENTRALLY-AFFILIATED CITY AND PROVINCE Pursuant to the Law on Fees and Charges dated November 25, 2015; Pursuant to the Government’s Decree No 120/2016/ND-CP dated August 23, 2016 specifying and providing guidance on implementation of several articles of the Law on Fees and Charges; Pursuant to the Government's Decree No 215/2013/ND-CP dated December 23, 2013 defining the functions, tasks, powers and organizational structure of the Ministry of Finance; Upon the request of the Director of the Tax Policy Department, The Minister of Finance hereby introduces the Circular providing guidance on fees and charges within the jurisdiction of the People’s Council of centrally-affiliated city and province Article Scope This Circular shall provide guidance on the classification, principles of and grounds for determining collection, exemption and reduction rates, management, and utilization, of fees and charges within the jurisdiction of the People’s Council of centrally-affiliated city and province (hereinafter referred to as provincial-level People’s Council) Article Classification of fees within the jurisdiction of the provincial-level People’s Council Fee for evaluation, selection and recognition of maternal plants, prototypical seedlings, forest plant variety gardens and plant variety forests (applicable to evaluation, selection and recognition activities performed by local authorities) Fee for utilization of public service or utility infrastructure and facilities within bordergate areas (including road and seaport bordergate areas) Toll road fee (applicable to roads under the scope of provincial-level delegated authority) Fee for temporary usage of public roads and pavements Fee for entrance to landscapes and landmarks (applicable to those under the scope of provinciallevel delegated authority) Fee for entrance to historic sites (applicable to those under the scope of provincial-level delegated authority) 7 Fee for entrance to cultural monuments and museums (applicable to those under the scope of provincial-level delegated authority) Fee for verification of eligibility for the certificate of conformance to operational conditions of sports establishments and professional sports clubs Fee for access to libraries (applicable to those under the scope of provincial-level delegated authority) 10 Fee for inspection of environmental impact evaluation reports and detailed environmental protection proposals (applicable to inspections conducted by regulatory authorities of a specified province) 11 Fee for inspection of plans for environmental remediation and recovery, and complementary plans for environmental remediation and recovery (applicable to ... management of import of medical equipment ANNEX II FORM OF APPLICATION FOR ISSUE OF MEDICAL EQUIPMENT IMPORT PERMIT (Issued with Circular No 30/ 2015/ TT-BYT dated 12/10 /2015 of the Minister of Health) ... addition or modified contents The notice of dossier completion is done only one time except for the case of contents which the Ministry of Health has given the notice of completion but the unit... 18 Revocation of medical equipment import Permit The cases of revocation of medical equipment import Permit: a) The importing unit forges the dossier for issue of medical equipment import Permit;