Production supervision and administration of medical devices (July 20, 2004, the State food and drug administration released 12th come into force on the date of promulgation) Chapter I General provisions article to strengthen the supervision and administration of medical device manufacturing, standardize the production order to ensure medical device is safe and effective, under the supervision and administration of medical devices Ordinance, these measures are formulated.     Supervision and administration of medical devices production refers to article II (food) drug supervision and management departments in accordance with the medical device manufacturing conditions and process reviews, management activities such as licensing, supervision and inspection.     Article III the State food and drug administration responsible for supervision and administration of medical devices production nationwide; and above the county level (food) the pharmaceutical supervisory and administrative departments shall be responsible for the supervision and administration of medical devices production within the administrative area.     Chapter start-up medical device manufacturing enterprise application, examination and approval article fourth start-up medical device production enterprises should be in line with the national industry development plans and industrial policies.     Fifth State food and Drug Administration should be in accordance with the provisions of the regulation on supervision and administration of medical devices, specifically provide for medical device manufacturing enterprise start-up conditions, develop appropriate for different categories of medical devices medical device manufacturing practices, and implementation.     Run sixth class I medical device manufacturers should have commensurate with product production conditions, and should be received within 30th of business licenses, fill out the manufacturers of class I medical devices registration form (see annex 1 to this approach), to the local provinces, autonomous regions and municipalities directly under the (food) pharmaceutical supervisory and administrative departments shall inform. Seventh start-up type II and class III medical device manufacturers must meet the following conditions: (a), head of quality and technology of production of enterprises should have the professional capacity commensurate with production of medical devices, and master relevant medical equipment supervision and management of the State, laws, regulations and rules and regulations related to product quality, technology. Quality Director may not act as head of production, (ii) the enterprise primary above title or secondary education technical staff accounted for the proportion of the total number of employees should be commensurate with production requirements; (c) the enterprise should have produced products and production to adapt to the size of production equipment, production, warehouse space and the environment.     Enterprise production on environment and equipment, has special requirements of medical devices of, should meet national standards, and industry standard and national about provides; (four) enterprise should established quality test institutions, and has and by production varieties and production scale phase adapted of quality test capacity; (five) enterprise should save and medical devices production and business about of legal, and regulations, and regulations and about technology standard.     Article eighth run class III medical device manufacturing enterprise, subject to requirements should be consistent with the approach the seventh article, it should meet the following conditions: (a) meet the requirements of quality management system internal auditor not less than two (ii) related intermediate professional title or a college education full time technicians at least two.     Nineth article opened second class, and third class medical devices production enterprise, should to enterprise location province, and autonomous regions, and municipalities (food) drug supervision management sector proposed application, fill in medical devices production enterprise license (opened) application table (see this approach annex 2), and submitted following material: (a) statutory representative people, and Enterprise head of basic situation and the qualification proved; (ii) business administration sector issued of proposed Enterprise name advance approved notice; (three) production site proved file;     (Four) enterprise production, and quality and technology head of resume, and degree or titles certificate; related professional technicians, and technology workers registration form, and marked where sector and post; senior, and intermediate, and primary technicians of proportion situation table; (five) intends production products range, and varieties and related products introduction; (six) main production equipment and test equipment directory; (seven) production quality management file directory; (eight) intends production products of process flowchart, and indicate main control project and control points;     (I) the production of sterile medical devices, shall report provides production detection.     The applicant should be responsible for the authenticity of all of their application materials. Tenth Article province, and autonomous regions, and municipalities (food) drug supervision management sector received application Hou, should according to following situation respectively made processing: (a) application matters law not belongs to this sector terms range of, should rates made not accepted of decided, and told applicants to about administrative organ application; (ii) application material exists can spot corrections of errors of, should allows application people spot corrections; (three) application material not complete or not meet form review requirements of,     Shall, on the spot or issued to the applicant within 5 working days notice of the correct materials, at once inform all applicants need to supplement content, fails to inform the, shall be accepted as of the date of receipt of the application materials; (d) the application materials are complete and conform to the form request for review or correction all application materials submitted as requested by the applicant, be admissible.     Provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative department accepting or not accepting an application for medical device manufacturers offer, shall receive special seal certificate with the Department and the date of the notification of acceptance or rejection notice. 11th to apply for the second class, a class III medical device manufacturers, provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments shall, within 30 days from the date of acceptance, in accordance with article seventh of this approach to the Nineth regulations and issued by the State food and Drug Administration medical device manufacturing practices to review applications.     Has not yet been promulgated and implemented the requirement of medical device manufacturing practices classification, in accordance with the provisions of article seventh to Nineth review. Following a review in conformity with the provisions and make a decision on issuing a written decision within 10 working days and issue a medical device manufacturing enterprise license (see annex 7 to this method).     Review does not meet the requirements, not issuing a written decision, and explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.     12th of provinces, autonomous regions and municipalities (food) administrative organ of the pharmaceutical supervisory and administrative departments shall website and publicity office space required for the medical device manufacturing enterprise license conditions, procedures, deadlines, need to submit all materials catalog and application model.     Provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall issue a medical device manufacturing enterprise license for information, should be made public, the public right of access. 13th of provinces, autonomous regions and municipalities (food) drug supervision and management departments of manufacturers of medical devices to run when applying for a review, should be public approval process and the results.     The applicant and interested parties to submit written views on matters directly related to the vital interests of State and to defend themselves. 14th article medical devices production Enterprise opened application directly involved applicants and others Zhijian major interests relationship of, province, and autonomous regions, and municipalities (food) drug supervision management sector should told applicants, and interest relationship people can in accordance with legal, and regulations and national food drug supervision authority of other provides enjoys application hearing of right; in on medical devices production Enterprise opened application for review Shi, province, and autonomous regions, and municipalities (food) drug supervision management sector think involved public interests of major license matters,     Shall be announced to the public, and hold a hearing.     Chapter III medical device manufacturing enterprise license-15th medical device manufacturing enterprise license original and copy, copy of the original and has the same legal effect, valid for 5 years.     Medical device manufacturing enterprise license uniformly printed by the State food and drug administration.     16th medical device manufacturing enterprise license shall contain the license number, business name, legal representative, heads of enterprises, registered address, the address, production scope, issuing authority, date of issue and term of validity issues.     Production range should include the product management category, category code and the name of the class of medical devices.     17th the medical device manufacturing enterprise license change into licensing changes and change of registered particulars.     License change is the legal representative, heads of enterprises, registered address, address range, production changes.     Change of registered particulars refer matters other than matters in addition to the above changes. 18th medical device manufacturers change licensing matters, should be before the original license is changed on 30th, fill in the medical device manufacturing enterprise license (change) application form (see annex 3 to this approach), submitted in accordance with the measures the Nineth involves changes of relevant material, the original issuing authority for the registration of the medical device manufacturing enterprise license. License issuing authority shall receive the enterprise change request and change within 15 working days from the date of the application to approve the change or not to change the decision. Allowed to change back the original license and issue a new card, after the change of the deadlines for medical device manufacturing enterprise license of unchanged.     No change, and shall state the reasons in writing and inform the applicants have the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.     Medical device manufacturers according to medical device manufacturing enterprise license licensing matters after the change, it shall register with the Administrative Department for industry and commerce enterprises registration procedures. 19th medical device manufacturers to change the registration of medical device manufacturing enterprise license shall be approved by the Administrative Department for industry and commerce in the 30th after the change, fill in the medical device manufacturing enterprise license (change) application form (see annex 3 to this way), the original issuing authority for the registration of the medical device manufacturing enterprise license. License issuing authority shall receive the enterprise change request and change within 15 working days from the date of the application for the change procedures.     In conformity with the provisions, recover the original license and issue a new certificate, after the change of the deadlines for medical device manufacturing enterprise license of unchanged. 20th Class II and class III medical device manufacturing enterprise merger, Division or cross-migration of original jurisdiction, and shall, in accordance with the provisions of article seventh to Nineth again for the medical device manufacturing enterprise license.     Class I medical device manufacturing enterprise merger, Division, cross the original jurisdiction for migration or inform change of registered particulars, it should be in the 30th after receiving new license or informed of the change of registered particulars in the 30th, as provided for in article sixth of this approach to the local provinces, autonomous regions and municipalities directly under the (food) pharmaceutical supervisory and administrative departments shall inform. 21st article second class, and third class medical devices production enterprise across province established this enterprise production site but no formed independent production enterprise of, should to original approval sector proposed application, fill in second class, and third class medical devices production enterprise across province established production site registration form (see this approach annex 4), and submitted related material, application medical devices production enterprise license change registration. The original examination and approval departments shall be handled in accordance with the measures the 18th article.     Granted the change, inform the original examination and approval departments shall change the location of the site of provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments. Class I medical device manufacturers across the province to set up production sites but did not form an independent production company, shall, in accordance with the provisions of the second paragraph of this article 20th, to inform the plaintiff knows the Registration Department in writing.     The plaintiffs know the Registration Department after receiving the written notice, shall inform seat of the production sites of provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments. Medical device manufacturers across the province to set up production facilities and formed an independent production company, shall, in accordance with article seventh of this approach to the Nineth of regulations of the medical device manufacturing enterprise license, or in accordance with the provisions of the present article sixth class I medical device manufacturers to inform registered.     The new seat of the production sites of provinces, autonomous regions and municipalities directly under the (food) issued by the pharmaceutical supervisory and administrative departments in the medical device manufacturing enterprise license or receive a class I medical device manufacturing enterprises informed in writing, shall inform the Registration Department informed the original examination and approval Department or the original. 22nd article medical devices production enterprise license validity expires need continues to production of, medical devices production enterprise should in validity expires Qian 6 months, to original sent card organ proposed renewal medical devices production enterprise license of application, fill in medical devices production enterprise license (renewal) application table (see this approach annex 5), and submitted original medical devices production enterprise license issued yilai or last medical devices production enterprise license     Nineth provided these measures since the renewal of material changes in the material. Primary certification authority combines enterprise implementation of laws and regulations, supervision and quality system, mutatis mutandis, the provisions of article 11th review to decide whether or not to issue a decision in the medical device manufacturing enterprise license. In conformity with the provisions, recover the original license recertification.     Does not meet the requirements, no replacement of the written decision and explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law. Provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative department in accordance with medical device manufacturers application shall, before the expiry date of the medical device manufacturing enterprise license decisions whether or not to grant their replacement.     Fails to make a decision, as agreed with the replacement, and go through the appropriate procedures. 23rd loss of the medical device manufacturing enterprise license, medical device manufacturers should apply immediately to the issuing authority to reissue, and posted on the media specified in the original Licensing Office declared lost.     Original issuing authority lost enterprises posted a statement after expiration of 1 month from the date of the original approval within 10 working days to reissue the medical device manufacturing enterprise license. 24th of provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments shall establish a medical device manufacturing enterprise license issuance, renewal, change, archive, and the medical device manufacturing enterprise license issuance, renewal, modification, replacement, revocation and cancellation conditions, submitted to the State food and drug administration at the end of each quarter.     Result of change, renewal, revocation, revocation, cancellation, recall and revocation of the medical device manufacturing enterprise license, file saved for 5 years.     25th no unit or individual shall not alter, resell, lease, lend or otherwise transfer the medical device manufacturing enterprise license.     Fourth chapter of medical device contract manufacturing management 26th principal medical device contract manufacturing should be having a medical device manufacturing enterprise license or in accordance with these rules for a class I medical device manufacturers to inform registered and obtained the registration certificate of medical devices production enterprises.     27th article medical devices delegate production of trustee party should is made medical devices production enterprise license or according to this approach provides for has first class medical devices production enterprise told registration of production enterprise, and meet following conditions: (a) its production range should covers trustee production of medical devices; (ii) production conditions, and detection capacity, and quality management system should and trustee production of medical devices phase adapted;     (C) single-use sterile medical devices and other provisions of State food and Drug Administration medical device, should adhere to the above requirements, trustees must also have covered the commissioned registration certificate of medical devices production. Delegate to a 28th will be responsible for production quality and sales of medical devices.     Clients should be entrusted the production conditions, make a study of the production technology and quality control of status, shall provide the trustee with commissioning of production technology and quality of medical devices, to guide and supervise the production process.     Trustee shall entrust the production of product registration certificate for medical device product standards, process for production and the requirements to keep all entrusted with the production of documents and records. 29th medical device contract manufacturing clients and trustees shall sign a written contract.     Delegate to a contract production may not exceed the term of validity of registration certificate of medical devices production.     30th article delegate party should since contract signed of day up 30th within, to its location province, and autonomous regions, and municipalities (food) drug supervision management sector registration record, fill in medical devices delegate production registration form (see this approach annex 6), and submitted following material: (a) delegate party and trustee party of medical devices production enterprise license or first class medical devices production enterprise registration form, and license copies;     (Ii) delegate party delegate production products of medical devices registered certificate and trustee party related products of medical devices registered certificate copies; (three) delegate production medical devices intends used of products standard, and production process, and manual, and label and packaging identifies; (four) delegate production contract copies; (five) delegate party on trustee party quality management system of recognized statement; (six) delegate party on medical devices quality, and sales and after-sales service responsibility of self guarantee statement.     Principal location of provinces, autonomous regions, or municipalities directly under the (food) after the drug supervision and management departments registration, the contract manufacturing of medical devices registration form CC should be where the trustee of provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments. 31st commissioned production of termination of the contract or registration content changes, client shall promptly to the local provinces, autonomous regions and municipalities directly under the (food) reports the drug regulatory agency.     Principal location of provinces, autonomous regions, or municipalities directly under the (food) the pharmaceutical supervisory and administrative departments shall inform the consignee location of provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments. Article 32nd prohibited contract manufacturing of medical devices.     Specific directory published by the State food and drug administration.     33rd medical device manufacturing enterprises in the production not as a medical device management components, components and materials, not part of the medical device contract manufacturing management.     34th commissioned production of medical equipment, manuals, labels, and packaging should indicate the principal name, consignee name and address.     Fifth chapter medical devices production of supervision check 35th article province, and autonomous regions, and municipalities (food) drug supervision management sector is responsible for management this administrative within medical devices production enterprise of supervision check work, established implementation supervision check of run mechanism, prepared this administrative within medical devices production enterprise annual supervision check plans, clear set district of city level (food) drug supervision management institutions and County (food) drug supervision management institutions of supervision check duties.     The State food and drug administration of the provinces, autonomous regions and municipalities should be (food) Drug Administration guidance and inspection of supervision and inspection work, and may require organizations to carry out spot checks on medical device manufacturers. 36th medical apparatus production supervision and inspection of the main contents of inspection of medical device manufacturers to implement the relevant laws, rules, regulations, and implementation of production quality management standard for medical devices.     Inspection including the issue of the medical device manufacturing enterprise license of on-site inspection, quality management standards tracking and daily supervision and inspection, and so on. 37th levels (food) the pharmaceutical supervisory and administrative departments monitoring and checking and screening programmes should be developed, clear criteria for checking record of on-site inspection, the results shall inform in writing the inspected enterprises.     Need corrective action should make rectification and reform period, and implement follow-up inspections. At the time of inspection, (food) the pharmaceutical supervisory and administrative departments shall assign two or more inspectors conducting supervision and inspection, the inspectors shall produce their certificates to the inspected enterprises.     (Food) staff aware of the drug regulatory agency of technical secrets of enterprises and business secrets shall be kept confidential.    Article 38th supervisory checks, (food) the pharmaceutical supervisory and administrative departments may, in accordance with inspection or require the manufacturers to provide relevant information and materials of the following: (a) the medical device manufacturing enterprise license and its changes and approval of medical device registration certificate and business license; (Ii) enterprise organization institutions, and production and quality main management personnel and production, and test conditions of changes and the approval situation; (three) enterprise production run situation and quality management situation; (four) medical devices production enterprise accept supervision check and the rectification implementation situation; (five) not qualified medical devices was notices Hou of rectification situation; (six) check organ need review of other necessary information. 39th above the county level (food) the pharmaceutical supervisory and administrative departments shall, in laws, rules and regulations gives permission, establish regulatory archive of medical device manufacturing enterprises in their respective administrative areas.     Regulatory record should include the registration and approval of medical devices, licensing, production supervision and inspection, product quality supervision and inspection, adverse event monitoring, records and reports of bad behavior, and more.     40th article County above place (food) drug supervision management sector should will supervision check in the found of production enterprise of following behavior remember into production enterprise regulatory archives: (a) production not meet national standards, and industry standard and registered products standard of medical devices of; (ii) beyond license range production medical devices of; (three) unauthorized reduced corresponding production conditions of; (four) violation medical devices manual, and label and packaging identifies management requirements of;     (V) does not provide for the establishment and the effective implementation of quality tracking and adverse event monitoring system (vi) illegal release of medical device advertising; (g) delegate to a without production of medical devices or medical device does not record; (VIII) other violations of laws, rules, regulations and requirements by the State food and drug administration.     41st (food) supervise and check the pharmaceutical supervisory and administrative departments shall be without prejudice to medical device manufacturing enterprises ' normal production activities, shall not solicit or accept a medical device manufacturer's property, shall not seek other interests.     42nd individuals and organizations found that medical device manufacturers for illegal production activities, the right to (food) the pharmaceutical supervisory and administrative departments, (food) the pharmaceutical supervisory and administrative departments shall promptly verify, process.     Article 43rd place above the county level (food) medicine bad behavior in the supervision and Management Department of the administrative records of the production enterprises, and product sampling frequency can increase supervision and inspection.     44th medical device manufacturers should be in production organizations on the effective operation of the quality management system, medical device manufacturing enterprises in the production of the same regulation and quality control requirements. 45th medical device manufacturing enterprises in the production of medical devices shall meet the national standards, industry standards and register product standard.     Sale of medical equipment shall be subject to inspection, and accompanied by a certificate.     Article 46th medical equipment across the province to set up production sites but has not formed an independent production company, seat of the production sites of provinces, autonomous regions and municipalities directly under the (food) supervision and administration of drug supervision and management is responsible for its day-to-day, and related to the original examination and approval of medical device manufacturers or the original informed registration departments.     Medical device contract manufacturing, where the trustee of provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative department entrusted the day-to-day supervision and management of enterprise and relevant information to the principal seat of the provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments. 47th medical device manufacturing enterprises reorganize production continuous production for more than a year, shall be notified in writing in advance the location of provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative departments.     Provinces, autonomous regions and municipalities (food) drug supervision and management departments should be carried out for medical device manufacturing enterprise quality system assessment or inspections.     48th medical device manufacturing enterprises should be carried out in accordance with the relevant provisions of the medical device adverse event monitoring and evaluation of listed products, and build-related files.     Class III medical device manufacturing enterprises should establish and implement product launch tracking system to ensure the traceability of the product.     49th medical device manufacturing enterprises in the production of significant quality accident for medical devices, shall immediately report the location of provinces, autonomous regions, municipalities directly under the (food) the pharmaceutical supervisory and administrative departments.     50th of the People's Republic of China on administrative licensing law (hereinafter referred to as the administrative licensing law) 70th circumstances, the issuing authority shall repay the tax write-off for medical device manufacturing enterprise license, and within 5 working days since the date of the cancellation notice about administration of industry and commerce. 51st above the county level (food) the pharmaceutical supervisory and administrative departments shall provide medical equipment supervisor.     Medical device regulations of the overseers shall be separately formulated by the State food and drug administration.     Sixth chapter legal liability article 52nd article 69th, one of the administrative licensing law, States or provinces, autonomous regions and municipalities directly under the food and Drug Administration (food) the pharmaceutical supervisory and administrative department according to the request of the interested party or ex officio, the medical device manufacturing enterprise license could be revoked.     53rd in violation of these rules, without the medical device manufacturing enterprise license producing category II and class III medical devices, in accordance with the supervision and administration of medical devices regulations 36th penalty.     Has not obtained the registration certificate of medical devices production of medical devices in accordance with the regulation on supervision and administration of medical devices article 35th of the punishment. 54th article violation this approach provides altered, and reselling, and rental, and lending or to other form illegal transfer medical devices production enterprise license of, by County above (food) drug supervision management sector ordered its corrected, can and at 10,000 yuan above 30,000 yuan following fine; for using altered, and reselling, and rental, and lending or to other form illegal transfer of medical devices production enterprise license of, ordered its corrected, which belongs to not made medical devices production enterprise license production second class, and     Of class III medical devices, in accordance with the supervision and administration of medical devices regulations 36th penalty.     55th applicant to hide relevant information or provides false information to apply for a medical device manufacturing enterprise license, provinces, autonomous regions and municipalities (food) inadmissible or not to approve the drug regulatory agency, and give it a warning, within one year, the applicant may not apply again for the medical device manufacturing enterprise license.     Through deception, bribery or other improper means to obtain the medical device manufacturing enterprise license, by the issuing authority to withdraw the medical device manufacturing enterprise license, have undertaken, in accordance with the supervision and administration of medical devices regulations 36th penalty in which the applicant may not apply again for the administrative license within three years.     56th production does not meet national standards, industry standards and register product standard for medical devices, in accordance with the regulation on supervision and administration of medical devices article 37th of the punishment.     57th article medical devices production enterprise has following case one of of, by location County above (food) drug supervision management sector give warning, ordered deadline corrected, can and at 30,000 yuan following fine: (a) first class medical devices production enterprise not by provides to (food) drug supervision management sector written told of; (ii) not by standard for test or products factory no certificate of; (three) not by provides handle medical devices production enterprise license change procedures of;     (Four) violation medical devices production quality management about requirements, unauthorized reduced production conditions of; (five) not by this approach provides registration record unauthorized delegate or trustee production medical devices of; (six) in without license of production site unauthorized production medical devices of; (seven) production third class medical devices not by provides established listed Hou track system of; (eight) not by provides report by occurred of major medical devices quality accident of; (nine) listed medical devices exists major security hidden and not corrected of;     (J) medical device manufacturers shut down for more than a year in a row, did not notify the location in advance of provinces, autonomous regions and municipalities directly under the (food) resumed the production of drug regulatory authorities (11) to be responsible for the supervision and inspection of (food) concealment of drug regulatory authorities, the provision of false information or refuse to provide authentic materials reflect its activities.     Medical device manufacturers listed in the preceding paragraph, if the circumstances are serious or harmful consequences, constitutes a breach of the relevant provisions of the regulation on supervision and administration of medical devices in accordance with the provisions of the regulation on supervision and administration of medical devices.     Article 58th in the implementation of the administrative license as provided herein in violation of relevant laws and regulations, in accordance with the relevant laws and regulations.     59th (food) the pharmaceutical supervisory and administrative department functionaries, malpractice, neglect their duties, constitutes a crime, investigated for criminal responsibility according to the relevant provisions of the criminal law by the judicial departments; does not constitute a crime, he shall be given administrative sanctions by the competent departments.     The seventh chapter by-laws 60th this approach by the State food and Drug Administration is responsible for the interpretation. 61st these measures come into force on the date of promulgation. On April 10, 2000, issued by the State Drug Administration measures for the supervision and administration of medical device manufacturing companies abolished at the same time.       Annex: 1. first class medical devices production enterprise registration form (format) 2. medical devices production enterprise license (opened) application table (format) 3. medical devices production enterprise license (change) application table (format) 4. second class, and third class medical devices production enterprise across province established production site registration form (format) 5. medical devices production enterprise license (renewal) application table (format) 6. medical devices delegate production registration form (format) 7. medical devices production enterprise license (format)      Annex 1: first class medical devices production enterprise registration form (format) Note: 1. This table only applies Yu first class medical devices production Enterprise 2. This table a type three copies, writing neat annex 2: medical devices production enterprise license (opened) application table (format) Note: this table a type three copies, writing neat annex 3: medical devices production enterprise license (change) application table (format) Note: this table a type three copies, writing neat Annex 4: second class, and third class medical devices production enterprise across province established production site registration form (format) Note: this table a type four copies, writing neat annex 5: medical devices production enterprise license (renewal) application table (format) Note: this table a type three copies, writing neat annex 6: medical devices delegate production registration form (format) Note: this table a type four copies, writing neat annex 7: medical devices production enterprise license (format) _______________________  __________________________________________________