Informative translation

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1 Informative translation Operational Communication May 30, 2011 To: The Health Department (Bureau) Pharmaceutical Affairs Section of each Prefecture Compliance and Narcotics Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare Questions and Answers (Q & A) on the Relationship between the QMS Ministerial Ordinance 1 and ISO13485: 2003 Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro diagnostic reagents (Ministerial Ordinance No. 169 of the Ministry of Health, Labour and Welfare in 2004; hereafter referred to as the QMS Ministerial Ordinance ) was prepared in keeping with ISO13485:2003 (hereafter referred to as ISO13485) in order to seek international harmonization and that article-by-article explanation was provided in Chapter 4.3 of Yaku-Shoku-Kan-Ma Hatsu Notification No Enactment, Revision and Abolishment of Ministerial Ordinances and Public Notices pertaining to the Manufacturing Controls and Quality Controls (GMP/QMS) of Medicines and Medical Devises, etc. accompany the Enforcement of Acts partially revising the Pharmaceuticals Affairs Law and the Law concerning the Regulation of Drawing of Blood and the Service of Supplying Donated Blood dated March 30, 2005 (hereafter referred to as enforcement notice ). Now, from the perspective of securing international harmonization, we have, in order to make even clearer the relation between the QMS Ministerial Ordinance and the ISO 13485, put together the following attachment regarding that point of view and hope that it will serve as a reference for operations. 1 NOTE by TÜV SÜD Japan, MHS The Ministerial Ordinance No. 169 of the Ministry of Health, Labour and Welfare in 2004 is referred to as the QMS Ministerial Ordinance in Japan. J-GMP is used as an abbreviation of the Ordinance within TÜV SÜD group, in order to avoid confusion between QMS, which is well known as an abbreviation of Quality Management System, and QMS Ministerial Ordinance, which is one of Japanese regulation. 1 / 10

2 Attachment (General) Q1 Is it correct to think that the QMS Ministerial Ordinance and the ISO13485 are completely the same? A1 The QMS Ministerial Ordinance was enacted taking into consideration ISO from the perspective of securing international harmonization and matches ISO 13845, excluding Chapter 3 which is applicable to packaging, etc. manufacturers, etc., the requirements of Chapter 4 which is applicable to Animal / human origin medical devices, etc. manufacturers, etc. and a portion of the additional requirements, etc. of Chapter 2 which is applicable to medical devices manufacturers, etc. Please refer to the Q & A below concerning the details of the additional requirements, etc. pertaining to Chapter 2. Q2 In the article-by-article explanation of Chapter 4.3 of the enforcement notice it is noted that this article corresponds to XXX of ISO or that this article corresponds to part of XXX of ISO 13485, but what does this mean? A2 Regarding the former, there are no modified requirements and have the same requirements as ISO (JIS Q 13485:2005) and, regarding the latter, additional requirements under the Pharmaceutical Affairs Law (Law No. 145 of 1960) are included. (In relation to Article 5 (Requirements pertaining to Quality Management Systems)) Q3 In Paragraph 4 it is written that Where the manufacturer, etc. choose to outsource any process that affects the conformity with the product requirements, the manufacturer, etc. shall ensure the control over such processes and processes which are the subject of manufacturing licenses or the accreditation of foreign manufacturers are excluded. When processes are subject to licenses or accreditations are outsourced, the control over this outsourced manufacturer, etc. shall be undertaken by the marketing authorization holder pursuant to Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices (Ministerial Ordinance No. 136, 2 / 10

3 2004 of the Ministry of Health, Labour and Welfare; hereafter referred to as the GQP Ministerial Ordinance), but is it acceptable for the manufacturer, etc. which receives the outsourcing of the marketing authorization holder to undertake this control or to jointly undertake this control with the marketing authorization holder? A3 Either method is acceptable. However, contract (including QMS Ministerial Ordinance Article 29) with the manufacturer, etc. pursuant the GQP Ministerial Ordinance shall be clearly documented. Additionally, it shall be kept in mind that ultimate responsibility for quality pertaining to the outsourced processes lies with the marketing authorization holder. Namely, the provisions of paragraph 4 shall not impede the execution of the control of a manufacturer, etc. which has obtained a license or accreditation to execute outsourced processes having clearly documented contract with the marketing authorization holder pursuant to the GQP Ministerial Ordinance by the outsourcing manufacturer, etc. (In relation to Article 6 (Documentation of Quality Management Systems)) Q4 In paragraph 2 the preparation of Seihin Hyojun Sho is required. When in an overseas manufacturing facility a DMR (Device Master Record), etc. is prepared corresponding to the laws and regulations of the respective nations, is it necessary to separately prepare the Seihin Hyojun Sho required in the Pharmaceutical Affairs Law? Also, with respect to those details, is it necessary to note the marketing approval (certificate) number, etc. indicated in the enforcement notice? A4 While Seihin Hyojun Sho is required to be prepared for each product, it is acceptable from the perspective of international harmonization to deem that a Seihin Hyojun Sho has been prepared when a document which prescribes required matters pertaining to the specification and quality management systems for each product is prepared pursuant to the regulations, etc. of each nation with the objective of appropriately controlling quality management documents. Additionally, when Seihin Hyojun Sho is prepared in foreign manufacturing facilities, it is acceptable not to note the marketing approval (certificate) number, etc. (In relation to Article 8 (Control of Documents)) Q5 Although it is noted in the enforcement notice that this Article corresponds to part of 3 / 10

4 ISO Control of documents, what are the differences in this Article? A5 The difference in this Article is the retention period of obsolete quality management documents or those copies prescribed in paragraph 4. In ISO it is required that documents used in manufacture or inspections have a retention period of at least the lifetime of the medical device determined by the organization (however, that period must not be shorter than the retention period of all records obtained as a result or the period prescribed in related regulatory requirements). However, in the QMS Ministerial Ordinance the retention period (however, documents pertaining to training is 5 years) set forth as follows from the date of the obsolete of the relevant quality management documents is required. However, it is sufficient to, at the least, store documents used in the manufacture of products or in tests and inspections so that the relevant documents can be used during the retention period of records pertaining to the relevant products prescribed in Article 9. (1) Products pertaining to specified maintenance control medical devices prescribed in Article 2, Paragraph 8 of the Pharmaceutical Affairs Law: 15 years (however, in respect to relevant products on which the notation of the validity period or expiration date (hereafter simply referred to as the validity period ) is required, when the period to which 1 year is added to that validity date is longer than 15 years, the period to which 1 year is added to the relevant validity period) (2) Products pertaining to medical devices other than specified maintenance control medical devices: 5 years (however, in respect to relevant products on which the notation of the validity period is required, when the period to which 1 year is added to that validity date is longer than 5 years, the period to which 1 year is added to the relevant validity period) (In relation to Article 9 (Control of Records)) Q6 Although it is noted in the enforcement notice that this Article corresponds to part of ISO Control of records, what are the differences in this Article? A6 The differences are the retention period of the records prescribed in paragraph 3 and the date from which the storage period is calculated. In ISO it is required to have a retention period of the lifetime of the medical device determined by the organization (however, that period must not be shorter than 2 years from the organization s shipment date or the period prescribed in related regulatory requirements). However, in the QMS 4 / 10

5 Ministerial Ordinance the retention period (however, records pertaining to training is 5 years) set forth as follows from the date of the preparation is required. (1) Products pertaining to specified maintenance control medical devices: 15 years (however, in respect to relevant products on which the notation of the validity period is required, when the period to which 1 year is added to that validity date is longer than 15 years, the period to which 1 year is added to the relevant validity period) (2) Products pertaining to medical devices other than specified maintenance control medical devices: 5 years (however, in respect to relevant products on which the notation of the validity period is required, when the period to which 1 year is added to that validity date is longer than 5 years, the period to which 1 year is added to the relevant validity period) (In relation to Article 10 (Management commitment)) Q7 In the enforcement notice it is stated that this Article corresponds to part of ISO Management commitment, but is it correct to think that the difference with this Article is that with respect to the customer requirements in the ISO 13485, because under the Pharmaceutical Affairs Law system, the customer of the manufacturer is the marketing authorization holder and other persons who receive the product and so, therefore, it is set forth in the QMS Ministerial Ordinance that the requirements of the customer of the manufacturer are those of the marketing authorization holder and other persons who receive the product? A7 This is acceptable. Even in the enforcement notice it is noted that the product recipient means the person indicated by marketing authorization holder, etc. pertaining to the relevant product. (In relation to Article 11 (Focus on the Product Recipient)) Q8 In the enforcement notice it is stated that this Article corresponds to part of the ISO Customer focus, but is it correct to think that the difference with this Article is that with respect to the customer requirements in the ISO 13485, because under the Pharmaceutical Affairs Law system, the customer of the manufacturer is the marketing authorization holder and other persons who receive the product and so, therefore, it is set forth in the QMS Ministerial Ordinance that the requirements of the customer of the manufacturer are those of the marketing authorization holder and 5 / 10

6 other persons who receive the product? Additionally, in a manufacturer, is it acceptable to operate without limiting the product recipient to the marketing authorization holder and other persons who receive the product? A8 Both are acceptable. (In relation to Article 16 (Responsible Engineering Manager)) Q9 In the enforcement notice it is stated that this Article corresponds to part of the ISO Management representative, but is it correct to think that the difference is that the responsibilities of the management representative required in ISO is defined in the QMS Ministerial Ordinance as the responsibilities of the Responsible Engineering Manager prescribed in Article 17, Paragraph 5 of the Pharmaceutical Affairs Law? Additionally, in the event that multiple manufacturing facilities, etc. are integrated and one quality management system is established, is it required to appoint the management representative noted in ISO for each manufacturing facility? A9 It is correct to think that the difference in this Article is that the requirements in the QMS Ministerial Ordinance have as the subject the Engineering Manager (in the case of a foreign manufacturer, the responsible person of the manufacturing facility which has received accreditation or the person designated in advance by the relevant foreign manufacturer) of the manufacturing facility prescribed in Article 17, Paragraph 5 of the Pharmaceutical Affairs Law and that the implementation of operations pertaining to the actual supervision regarding quality management systems in that manufacturing facility are required. In the event that multiple manufacturing facilities, etc. are integrated and one quality management system is established, it is not required to appoint the so-called management representative of ISO for each manufacturing facility regardless of the provisions of ISO and it is acceptable to appoint in advance engineering managers in domestic manufacturing facilities or a staff who is able to fulfill the duties as the management representative for each manufacturing facility in foreign manufacturing facilities. Although the duties of the management representative required in ISO and the Engineering Manager required in the QMS Ministerial Ordinance are the same, it should be kept in mind that, as it is not necessarily the case that the same person will be appointed, each manufacturer shall make clear those roles and ensure that the duties of the Engineering Manager do not 6 / 10

7 become a mere formality. (In relation to Article 23 (Training, etc.)) Q10 In the enforcement notice it is stated that this Article corresponds to the ISO Competence, awareness and training, but in Item 2 it is stated To establish the documented procedure for identifying the training needs On the one hand, in the ISO this is not a requirement and, as a note it is stated that National or regional regulations might require the organization to establish documented procedures for identifying training needs. Is this an additional requirement? A10 This is an additional requirement. (In relation to Article 24 (Infrastructure)) Q11 In the enforcement notice it is stated that Article 24, Paragraph 1, Paragraph 3 and Paragraph 4 correspond to the ISO Infrastructure, but is Article 24, Paragraph 2 an additional requirement? A11 Paragraph 2 is an added requirement with respect to buildings and facilities being in accordance with product characteristics. There is no difference as regards Paragraph 1, Paragraph 3 and Paragraph 4. (In relation to Article 42 (Installation Activities)) Q12 Although it is noted in the enforcement notice that this Article corresponds in part to ISO Installation activities, what is the difference? A12 This set forth what the manufacturer, etc. has to implement and is in line with the requirements of Pharmaceutical Affairs Law Enforcement Regulations (Ministry of Health and Welfare Ministerial Ordinance No. 1, 1961) Article 93 and Article 179 and is not an additional requirement. (In relation to Article 44 (Manufacturing Controls of Sterile Products)) Q13 In the enforcement notice it is stated that this corresponds to the Particular 7 / 10

8 requirements for sterile medical devices of ISO 13485, but is paragraph 3 an additional requirement in respect to ISO 13485? A13 It is an additional requirement. In respect to sterile medical devices manufactures, etc., it added a building and facilities requirement being in accordance with product characteristics. (In relation to Article 49 (Traceability of Products pertaining to Specified Medical Devices)) Q14 In the enforcement notice it is stated that this Article corresponds to part of the Particular requirements for active implantable medical devices and implantable medical devices of ISO 13845, but what is the difference with this Article? A14 In ISO there is a requirement in respect to active implantable medical devices and implantable medical devices, but in the QMS Ministerial Ordinance the subject is restricted to the specified medical devises prescribed in Article 77-5 of the Pharmaceutical Affairs Law and the changed requirement is in accordance with this. (In relation to Article 56 (Internal Audit)) Q15 As the enforcement order notes that this Article corresponds to the ISO Internal audit, is it appropriate to judge that if an internal audit with the ISO standards is implemented that this will be in conformity with this Article? A15 As this Article prescribes that an internal audit be undertaken in order to make clear whether the provisions of this ministerial ordinance and the requirements pertaining to the relevant quality management systems are being conformed to, it cannot be judged that this Article is being conformed to with the results of the internal audit having the audit standards of ISO alone. On the basis of the conformity report based on an internal audit pursuant to ISO 13485, it is acceptable to judge that this Article is being conformed to base on an internal audit made with the addition of the differences with the QMS Ministerial Ordinance. (In relation to Article 58 (Monitoring and Measurement of Products)) Q16 8 / 10

9 Although it is stated in the enforcement order that this Article corresponds to the Monitoring and measurement of product of ISO 13485, it is stated in paragraph 5 that manufacturers, etc. must not permit the advancement to the following stage of the process, determine whether or not to ship the product from the manufacturing facility or provide services until the completion without any problems of the monitoring and measurement pursuant to the implementation guidelines prescribed in the product realization plan. In ISO it is required that the shipment of products and the provision of services will not be undertaken until the completion without problems of the matters decided in the planning (refer to 7.1) of product realization. Is permit the advancement to the following stage of the process an additional requirement? A16 It is not an additional requirement. It is acceptable to reason that this is the same as the requirement in ISO because, with respect to permit the advancement to the following stage of the process, a firm will make a determination as to what stage confirmation should be made on the basis of information such as design development and risk management, etc., and will confirm before advancing to the following stage that monitoring and measurement pursuant to the implementation guidelines prescribed in the product realization plan has been completed without any problems. (In relation to Article 60 (Control of Nonconforming Products)) Q17 Although in the enforcement notice it is stated that this Article corresponds to 8.3 Control of nonconforming product of ISO 13485, the new work instructions must be prepared in paragraph 9 can be read as though there is a requirement to redraft the work instructions each time. Is this an additional requirement in respect to the documentation of the rework process of shall document the rework process in a work instruction of ISO 13485? A17 It is not an additional requirement. The new work instructions must be prepared in paragraph 9 is not a requirement to redo the work instructions each time. As this required the redrafting of the work instructions based on similar procedures when in the original work instructions there are aspects which cannot address processes in the event manufacturing is revised with respect to that product, it is acceptable not to redraft if the work instructions to begin with considered the impact of revising manufacturing and, furthermore, if manufacturing is revised within that scope. The record of the revised manufacturing and the judgment as to whether it is within the 9 / 10

10 scope of the work instructions when the work instructions are not redrafted is secured in paragraph 3 and paragraph 6. (In relation to Article 62 (Improvements)) Q18 Although it is stated in the enforcement notice that this Article corresponds to Improvement General of ISO 13485, is the this provision shall not apply in case where the customer issues and implements the advisory notices, and the manufacturer, etc. shall provide the customer with the information necessary for issuing the advisory notices prescribed in Article 62, Paragraph 2 an additional requirement in relation to the requirements of ISO 13485? Additionally, in what way can the manufacturer demonstrate this to the auditor? A18 It is not an additional requirement. It was noted in order to harmonize the operations of the marketing authorization holder required in the Pharmaceutical Affairs Law. As a method of demonstrating to the auditor that the product recipient proactively issues and implements the advisory notices, one can think of providing a documented procedure, etc. for providing the product recipient required information in the issuance of advisory notices which have been approved by the product recipient or letters of agreement / memorandums of understanding, etc. with the product recipient and the manufacturer, etc. in which those details are set forth. It is desirable the documented procedure, etc. for providing the product recipient required information in the issuance of advisory notices be prepared taking into consideration the importance of advisory notices and the requirements of this paragraph. 10 / 10