Response to Regulatory Impact Assessment (RIA) for the Proposed Regulation of Medical Devices in Hong Kong. Issued by Department of Health DH

Response to Regulatory Impact Assessment (RIA) for the Proposed Regulation of Medical Devices in Hong Kong Issued by Department of Health DH Submitted by Hong Kong Medical and Healthcare Device Manufacturers Association HKMHDMA Background The Hong Kong SAR Government commissioned ERM Hong Kong Limited ERM to conduct the captioned RIA study, with an aim to assess the likely impacts of the proposed regulation of medical devices ( Regulation ). ERM invited major stakeholders to attend focus group sessions to collect their opinion on the Regulation. HKMHDMA s representative attended a focus group session held on September 3, 2007. Our Board members then convened and presently summarize our opinion in this response. Our Response HKMHDMA applauds the introduction of the Regulations of Medical Devices. We support the regulation of medical devices using a framework of pre-market and post-market controls in a risk-based approach congruent with international practices adopted by the Global Harmonization Task Force (GHTF). We view that the promulgation of Regulations will promote medical device safety and performance. To serve such public interests, we are cognizant of the role that stakeholders of medical device play in placing medical devices on the market. Among the duties of various stakeholders are registration (listing) of higher risk medical devices; implementation of quality management systems in the design, manufacturing and distribution of medical devices; and the establishment of procedures for the traceability of certain medical devices, user complaints handling and product recalls. We believe that the regulatory requirements imposed on various stakeholders need to be justified with public interests that such requirements serve. HKMHDMA supports the Requirements as discussed in the Consultation Page 1 of 18

Document 1 generally but would like to make the following comments and recommendations. 1. HKMHDMA recommends the Government to clearly define the purpose of the Regulations as to ensure that safety and performance of medical devices marketed in Hong Kong. The scope of performance should be within the meaning of the manufacturer s statement of the intended purpose of the medical device. The Consultation Document stated in its INTRODUCTION the purpose of the Regulations as to ensure that medical devices marketed in Hong Kong are safe, efficacious and of quality, which appears to deviate from the purpose under the present Medical Device Administrative Control System (MDACS) and does not synchronize with GHTF approach. i. We understand the purpose of the present MDACS as to ensure that medical devices are safe and perform according to intended purpose. (See, e.g. Guidance Note TR001, Section 2.1.1. The MDACS is intended to ensure a high level of protection of public health and safety. Public trust and confidence in medical devices, and in the administrative systems by which they are controlled, are based on the safety and performance of such products throughout their life cycle) 2 ii. We further understand that GHTF, for example in defining the principles of conformity assessment for medical devices, clearly focuses on the safety and performance of medical devices. 3 Thus, the proposed purpose appears to deviate from the purpose as stated in the present MDACS voluntary scheme and does not synchronize with GHTF approach, which to our understanding, 1 Regulation of Medical Devices - Consultation Document, Department of Health, Government of the Hong Kong Special Administrative Region. The People s Republic of China. Received by HKMDHMA on Aug 28, 2007. 2 Principles of Conformity Assessment of Medical Devices Technical Reference: TR-001. Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 13, Oct. 2006. 3 Study Group I, Global Harmonization Task Force. Principles of Conformity Assessment for Medical Devices- Final Document, GHTF/SG1/N40:2006. http://www.ghtf.org/sg1/inventorysg1/sg1n40%202006-conformity-assessment-final.doc accessed September 10, 2007. Page 2 of 18

iii. iv. departs from DH s goal. The Regulations proposed purpose in the Consultation Document appears to be an unnecessary expansion of the scope of examination into a medical device s attributes, which arguably may subject a medical device to a higher level of scrutiny based on quality or performance NOT claimed by its manufacturer. The foreseeable result of the proposed purpose is that during the examination of a device requiring pre-market approval, unnecessary governmental resource may be placed on understanding, interpreting, deciding and verifying which elements of a medical device constitutes its efficaciousness and quality. Alternatively, the examination of a medical device s performance according to the manufacturer s statement of intended purpose provides a more logical and pragmatic framework for its pre-market examination. The Regulations propose pre-market control in labeling and post-market control in mislabeling or false claim, which we support. It is foreseeable that the proposed purpose of the Regulations will leave room for interpretation of what constitutes a mislabel or false claim, which will likely create quite an administrative difficulty in enforcement. This may be avoided if the Regulations clearly define the purpose as to ensure the medical device s safety and performance according to intended purpose. Having validated that the device performs according to its intended purpose, the Regulations should further require that the intended purpose statement become part of the medical device s label. During enforcement of mislabeling or false claim actions, the intended purpose statement should be used as a basis of investigation. 2. HKMHDMA agrees with the proposed Regulations in requiring pre-market approval of Class II to IV devices, that is, by registration or listing because such a method of control is generally adopted by regulatory approaches undertaken elsewhere including those of GHTF members. 3. HKMHDMA is in favor of requiring Class I devices to be notified of its conformity with the Essential Principles of Safety and Performance of Medical Page 3 of 18

Devices 4 with the exception of Class I devices that are sterile or have a measuring function, which requires pre-market approval (registration). The Consultation Document advises that DH is considering two different approaches in regulating Class I devices All Class I devices to provide notification that their product complies with the Essential Principles of Safety and Performance of Medical Devices as provided in GN-01 OR, Class I devices that are sterile or have a measuring function are required to register, while the rest of Class I devices only provide notification as above i. Class I devices are devices of low risk. The measures of control of Class I devices using a risk-based approach should accordingly be lighter than those intended for higher risk devices. Such is also the principle of GHTF s approach. Hence, we opine that notification of conformity should suffice as the pre-market control measure for Class I devices with the exception of devices that are sterile or have measuring function. ii. Within Class I are certain sterile devices or devices having measuring function. Such devices arguably pose somewhat higher risk than other Class I devices should their performance specific to sterility or measurement accuracy is compromised. Thus, we are of the opinion that the conformity assessment of these devices sterility and measurement performance requires a more involved process than notification. Regulatory approaches elsewhere on these devices are instructive. For example, compared to other Class I devices, the European Union Medical Device Directive requires Class I devices marketed in a sterile condition or perform measurement functions to subject to additional Quality Assurance System requirements. 5 Similarly, GHTF s Essential Principles of Safety and Performance 4 Principles of Conformity Assessment of Medical Devices Technical Reference: TR-001. Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 13, Oct. 2006. Summary Technical Documentation for Demonstrating Conformity of the Essential Principles of Safety and Performance of Medical Devices Technical Reference: TR-002. Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 13, Oct. 2006. 5 Council Directive 93/42/EEC, 1993 O.J. (Annex VII) (L 169); Council Directive 98/79/EC, 1998 O.J. (Annex III) (L 331); Council Directive 93/42/EEC, 1993 O.J. (Annex VII.5) (L 169). Page 4 of 18

of Medical Devices also prescribe specific guidelines for the conformity assessment of such devices performance. 6 4. In the context of pre-market notification of Class I devices, HKMHDMA is NOT in favor of replacing the registration (listing) of importers. We recommend the registration of importers to continue as suggested in the present MDACS voluntary scheme and notification of Class I devices to be included under importer registration requirements. The Consultation Document advises that DH is considering the replacement of 6 Study Group I, Global Harmonization Task Force. Principles of Conformity Assessment for Medical Devices- Final Document, GHTF/SG1/N40:2006. http://www.ghtf.org/sg1/inventorysg1/sg1n40%202006-conformity-assessment-final.doc accessed September 10, 2007. 5.8 Infection and microbial contamination 5.8.6 Devices delivered in a sterile state should be designed, manufactured and packed in a non-reusable pack, and/or according to appropriate procedures, to ensure that they are sterile when placed on the market and remain sterile, under the transport and storage conditions indicated by the manufacturer, until the protective packaging is damaged or opened. 5.8.7 Devices labelled either as sterile or as having a special microbiological state should have been processed, manufactured and, if applicable, sterilized by appropriate, validated methods. 5.8.8 Devices intended to be sterilized should be manufactured in appropriately controlled (e.g. environmental) conditions. 5.8.9 Packaging systems for non-sterile devices should keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system should be suitable taking account of the method of sterilization indicated by the manufacturer. 5.10 Devices with a diagnostic or measuring function 5.10.1 Devices with a measuring function, where inaccuracy could have a significant adverse effect on the patient, should be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended purpose of the device. The limits of accuracy should be indicated by the manufacturer. 5.10.2 Diagnostic devices should be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended use, based on appropriate scientific and technical methods. In particular the design should address sensitivity, specificity, trueness, repeatability, reproducibility, control of known relevant interference and limits of detection, as appropriate. 5.10.3 Where the performance of devices depends on the use of calibrators and/or control materials, the traceability of values assigned to such calibrators and/or control materials should be assured through a quality management system. 5.10.4 Any measurement, monitoring or display scale should be designed in line with ergonomic principles, taking account of the intended purpose of the device. 5.10.5 Wherever possible values expressed numerically should be in commonly accepted, standardised units, and understood by the users of the device. Page 5 of 18

importers registration with either approach in regulating Class I devices, as discussed in Recommendation 3. We do not view the registration of importers and notification of Class I devices mutually exclusive. i. Certainly, it may be required that each Class I device s notification of conformity be submitted individually. However, understanding that most Importers carry dozens or even hundreds of Class I devices in their product range, the submission and processing of individual notifications will be an unnecessary human resource burden to both importers and DH. Instead, the current MDACS Importer Listing 7 procedures may be adopted whereby each importer submits, together with its importer listing application, a list of imported devices. Contained in the list of imported devices should be Class I devices requiring notification. Some modification on the method of submitting Class I device notification, such as electronic submission, may also be considered. ii. Further to the human resource burden that individual notification of Class I devices adds, HKMHDMA is concerned about the probable financial impact to Importers. It is not known if a fee will apply to Class I device notification. Presuming the requirement of a device notification fee, a typical Class I device Importer who carries multiple Class I devices will bear multiple assessments of such a fee. The scale of financial impact of such a fee should not be compared to the registration fee contemplated for Class II to IV devices as there exist vastly more Class I devices imported than Class II to IV devices. 5. HKMHDMA supports the regulation of in-vitro diagnostic devices (IVDD). However, based on the foreseeable resource requirement on the regulation of medical devices, we advise the Government to prioritize in the favor of regulating medical devices than IVDD, whether or not IVDD is included in the 7 Guidance Notes for Listing of Importers of Medical Devices (GN-07), Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 17 July, 2007. Page 6 of 18

scope of the medical device regulation. The Consultation Document advises that DH is currently considering whether to include in vitro diagnostic devices (IVDD) in the regulatory control. IVDD are devices that are intended for use in the collection, preparation, and examination of specimens taken from the human body for diagnosis of disease or other conditions (e.g. pregnancy). MDACS currently excludes IVDD while some overseas countries have included them within the scope of control for medical device. i. Undoubtedly, IVDD play an important role as diagnostic aids in indicating to the user, a patient s health or disease condition. It is foreseeable that design or manufacturing fault in such devices will mislead the user in understanding a patient s medical condition and thus resulting in improper patient care. Thus, it is clear to HKMHDMA that IVDD should be regulated. However, given the anticipated vast resource requirement on regulating Class I to IV devices, the Government should prioritize the timing of regulating Class I to IV devices before IVDD. ii. Furthermore, we understand that GHTF is currently seeking comments on the Classification and Principles of Conformity Assessment of IVDD. 8 The final version of these guidance documents on IVDD will be released at a later stage. HKMHDMA advises the Government to study the mechanism of regulating IVDD, its timeline, regulatory impact and appropriateness of including it within the framework of medical device regulation after the final documents are published. 6. HKMHDMA agrees with the proposed Regulations in providing exemption from registration of devices intended for re-export, at the discretion of DH certain borderline devices and devices intended for emergency or experimental 8 Study Group I, Global Harmonization Task Force. Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.- Proposed Document, SG1/N045. February 9, 2007; http://www.ghtf.org/sg1/inventorysg1/sg1-pd-n45-r12.doc accessed September 10, 2007. Study Group I, Global Harmonization Task Force. Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices SG1(PD)/N046R3, February 9, 2007. Page 7 of 18

use. We reason that the allowance of certain exemption provides flexibility in regulating such devices and that the approach is frequently undertaken by regulatory approaches elsewhere. 7. HKMHDMA agrees with the proposed Regulations in requiring the registration of Local Manufacturers, Local-Responsible-Persons (LRP), Importers and Conformity Assessment Bodies (CAB). These stakeholders are responsible for placing medical devices on the market and for CABs, conducting conformity assessment of medical devices. Collaboration of these stakeholders in fulfilling their responsibilities is essential for the successful implementation of the Regulations. HKMHDMA sees defining their obligations and mandating their registration as the cornerstones of the Regulations. 8. HKMHDMA agrees with the proposed Regulations on post-market controls of adverse incident reporting, recalls, tracking and trending certain medical devices. These are fundamental post-market control measures essential for ensuring the safety and performance of medical devices that are in the users possession. They are also measures commonly undertaken by regulatory approaches elsewhere. 9. HKMHDMA agrees with the proposed Regulations on the control on advertisements. We would like to draw Government s attention to our discussion in Recommendation 1 concerning medical device labeling. We emphasize again the importance of regulating the intended purpose of a medical device to avoid ambiguity in interpreting false claims. 10. HKMHDMA agrees with the proposed Regulations on the control on the use and operation of medical devices but recommends that the control of possession of certain high-risk medical devices should also be at the point of sale. http://www.ghtf.org/sg1/inventorysg1/sg1-pd-n046-r3.doc accessed September 10, 2007. Page 8 of 18

The Consultation Document advises that DH is proposing to implement a licensing system to track ownership of specified equipment such as high powered lasers and to limit their use to qualified professionals (e.g. doctors and dentists). Owners are required to file an application for the possession and have to undertake to comply with a set of conditions of use. As for intense pulsed light devices, it is proposed to allow non-medical personnel, who have undergone recognized training, to use them to perform specified procedures such as hair removal and skin rejuvenation. Under the proposed regulations, DH will be able to specify which products should be subjected to such licensing restrictions. i. It is reasonable to require qualified professionals to register their possession of medical devices such as high-powered lasers. However, nothing in the proposed Regulations prevents an importer, distributor or retailer from selling such a medical device to non-qualified individuals. It is foreseeable that medical devices that DH specifies to control their use and operation can fall into hands of non-qualified individuals, thus defeating the purpose such restriction in the first place. HKMHDMA recommends that control at the point of sale is necessary for certain high-risk medical devices to properly control the use and operation of such devices. 11. HKMHDMA agrees with the proposed Regulations that the control of maintenance or refurbishment of medical devices is necessary. We further recommend that maintenance or refurbishment of certain higher risk medical devices be subject to additional requirements to ensure their safety and performance. The Consultation Document defines refurbished medical devices as devices that have been rebuilt from one or more used medical devices built for either its original or a different purpose. It is proposed that such devices will be regulated in the same way as any ordinary medical device, and will be classified in the same manner. The Consultation Document does not describe how DH plans to regulate the repair and maintenance of medical devices. Page 9 of 18

i. HKMHDMA views that one who undertakes to refurbish a medical device essentially re-manufactures the device for sale. Refurbishment should be distinguished from repair or maintenance, which does not entail a change in the ownership of the medical device. Different scenarios are foreseen in refurbishment of medical devices. First, the undertaker of medical device refurbishment may be the original equipment manufacturer (OEM) or its appointed agent. Alternatively, the undertaker may be a third party manufacturer who bears no relation to OEM. Second, refurbishment may involve a component of the medical device not critical to its function, for example, the replacement of damaged packaging, or a critical component essential to the proper function of the device, such as the sensor of an electronic thermometer. Third, as the Consultation Document describes, the refurbished medical device may serve purposes same as or entirely different from those of the original medical device(s). ii. HKMHDMA agrees that the refurbished medical device must be classified according to its purpose and risk level, not unlike new devices. The purpose and risk level of a refurbished device may or may not be the same as medical device(s) from which it derives. iii. HKMHDMA views that the conformity assessment of Essential Principles of Safety and Performance of the refurbished devices is clearly necessary in the following circumstances whether the undertaker of refurbishment is OEM or a third party manufacturer: if refurbishment concerns higher-risk medical devices or if refurbishment involves a component which, if incorrectly refurbished, can affect the safety or performance of any medical device requiring registration. iv. HKMHDMA also views for certain higher risk medical devices, refurbishment must be conducted exclusively by OEM or its appointed agent. v. For invasive medical devices that are intended to be introduced into a patient s body or body orifices, HKMHDMA suggests the prohibition of sale of such refurbished devices and the salvage of such devices parts or components for refurbishment. vi. HKMHDMA thinks that repair and maintenance of medical devices should be Page 10 of 18

regulated using similar principles as suggested in iii and iv for refurbished devices. 12. HKMHDMA is somewhat in agreement with the transition arrangement timeline because it prioritized higher risked devices in an earlier order of regulation. However, HKMHDMA proposes to modify the arrangement to include a pre-registration phase preceding the implementation phase. The Consultation Document contains a proposed schedule of implementation (Table 1.3) as follows: i. As discussed hereinafter under Recommendation 16, HKMHDMA is concerned, especially during the early implementation of Regulations, that underestimation of human resource requirement to deal with the surge of applications will lead to serious backlog in registration approval of medical devices, Importers and Local Manufacturers. According to the proposed schedule of implementation, it is foreseeable that last-minute applications submitted weeks before the deadline of full implementation will overload DH. Furthermore, the setting of rigid full implementation timeline without escape does not afford any margin of error in Page 11 of 18

estimating resource requirement needed for each category of applications received by DH. ii. iii. iv. HKMHDMA proposed the inclusion of a 12-month pre-registration phase to precede the implementation stage without compromising the overall full implementation timeline. The pre-registration phase commences immediately after promulgation of Regulations and terminates 12 months thereafter. Before the termination of pre-registration, applications must be received by DH for the registration of then marketed Class I sterile devices and devices with measuring function, Class II to IV medical devices, and for Importers (notification of Class I devices) then in operation. During the pre-registration phase, DH s resource should be spent mainly on examining the completeness of applications. Successful pre-registration grants the applicant continued privilege in marketing the devices until the commencement date of full-implementation in each device category, which in any case should be no later than 30 months post-promulgation. Between 12 and 30 months post-promulgation is an 18-month implementation period during which DH examines and approves pre-registered devices in the order of risk category. For example, full implementation timeline of Class IV, III, II and I devices may be 16½, 21, 25½ and 30 month post-promulgation respectively. DH s allocation of its resource during the 18-month implementation should be assessed based on the number of pre-registered devices in each category. This information should be known to DH at 12 month post-promulgation. v. The pre-registration and full-implementation timelines that HKMHDMA proposes are illustrative. The incorporation of a pre-registration phase in the transition arrangement should minimize the impact of unanticipated, or rather a foreseeable, sudden surge in last-minute applications. It also provides DH a better opportunity to plan for resource requirement in order to meet the full implementation workload. 13. HKMHDMA agrees with the frequency of 5-year registration renewal of medical devices, CAB and Local Manufacturers registrations and the 2-year Page 12 of 18

renewal of Importer registration. We reasoned that the frequency of renewal is an appropriate balance between financial/administrative burden imposed on the regulated and public s need to be assured that the regulated continues to market devices that conform to Essential Principles of Safety and Performance. 9 14. HKMHDMA understands that fees will be set at a level that would lead to full cost recovery for the administration of the scheme, excluding cost of enforcement. We advise that the fees should be comparable to registration fees of pharmaceutical products and Chinese herbal medicine in Hong Kong. In addition to the responses that we made above according to the outline of the Consultation Document, we would like to recommend the following based on our experience with MDACS. 9 Principles of Conformity Assessment of Medical Devices Technical Reference: TR-001. Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 13, Oct. 2006. Summary Technical Documentation for Demonstrating Conformity of the Essential Principles of Safety and Performance of Medical Devices Technical Reference: TR-002. Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 13, Oct. 2006. Page 13 of 18

15. HKMHDMA recommends the establishment under Ordinance of a Medical Device Board Board for the purpose of advising, monitoring and implementing the proposed Regulations. i. The regulation of medical devices is a serious undertaking of the Government in protecting public interest against unsafe and insufficiently performing medical devices. HKMHDMA applauds DH in involving stakeholders during various stages of MDACS implementation and currently in the RIA. The continual engagement of stakeholders after promulgation of the Regulations is essential for its ongoing success. We propose the Board s composition to include the Director of Health (chair), other DH officials, and representatives of stakeholder organizations. ii. HKMHDMA suggests that the Board may establish a number of executive committees as it may deem fit for the purpose of performing such functions relating to: (a) pre-market controls including the registration of CABs, Importers, Local Manufacturers, or medical devices; (b) medical device classification including the determination of exemption and exclusion devices; (c) post-market controls including device recall and disciplinary actions. 16. HKMHDMA recommends the Government to allocate appropriate resource to DH for carrying out its duties under the Regulations HKMHDMA has been a stern supporter of the Government s effort in regulating medical device in Hong Kong. We believe that the Regulations will serve the public interest of protection against mishaps caused by insufficiently designed or manufactured medical devices. We are also of the opinion that such regulations promote public understanding of medical devices and facilitate local and international trading of sound medical devices. Medical device Regulations demands an enormous regulatory resource to administer. We have seen examples elsewhere the deleterious effects of having Page 14 of 18

insufficient resource and management allocated during the formative stages of medical device regulation causing: a) Huge backlog in medical device application approval b) Beneficial and life-saving medical devices not promptly reaching the public c) Serious financial implication to manufacturers and importers due to prolonged delay in obtaining device approval for marketing. HKMHDMA hopes to use the occasion to recommend to the Government not to underestimate the resource requirement in implementing MDACS. 17. HKMHDMA recommends the clarification of Local Manufacturer (LM) interpretation pursuant to Section 3.5 of Guidance Notes for Listing of Local Manufacturers 10 (GN-08) Section 3.5 of GN-08 interprets a local manufacturer to mean a manufacturer whose business as a manufacturer of medical devices has either been registered in Hong Kong or is part of a business which has been so registered. i. From the literal interpretation of the section, a LM must have its business as a manufacturer of medical device as it appears on its business registration. Alternatively, the LM is part of a business operation, which we interpret it to be a separate parent or holding company, which has in its business registration the business activity of medical device manufacturing. ii. iii. Medical Device Control Office (MDCO) has clarified with HKMHDMA that the intent of section was to accept business activities other than or in addition to medical device manufacturing as they appear on LM s business registration. It appears that section 3.5 allows for more than one interpretation. We believe that the meaning of LM requires clarification. 10 Guidance Notes for Listing of Local Manufacturers : GN-08. Department of Health, The Government of the Page 15 of 18

18. HKMHDMA recommends the amendment of Importer definition pursuant to Section 2.1 of Guidance Notes for Listing of Importer 11 (GN-07) to mean a legal or natural person who imports into Hong Kong in the course of its business medical devices that fall within the scope of the MDACS" and delete Section 6.6. Section 2.1 of GN-07 defines Importer to mean a legal or natural person who brings or causes to be brought into Hong Kong any medical devices falling within the scope of the MDACS for distribution or use in Hong Kong but does not include any person who is employed or engaged by such person to carry such products into Hong Kong but excludes from this listing requirement, in Section 6.6, "[a] natural or legal person who imports medical devices for use exclusively in the treatment or care of himself, his immediate family, relatives or dependents." i. Section 6.6 exclusion is designed to exclude individuals who import medical devices for personal use as Importers. We view that the extension of personal use to those of immediate family, relatives and dependents can have broad application depending on how far a family tree extends, which can also be difficult for MDCO to administratively define. ii. iii. Furthermore, nothing in Section 6.6 prevents a person from importing medical devices for use exclusively in the treatment or care of his immediate family, relatives or dependents for profit or causing the medical devices to be resold for profit. In adopting our proposed definition, a person who brings into Hong Kong medical devices not in the course of its business still enjoys the personal use exemption as intended in Section 6.6. 19. HKMHDMA recommends the active recruitment of more Conformity Assessment Bodies (CABs) Hong Kong Special Administrative Region of the People s Republic of China. 23, Mar. 2007. 11 Guidance Notes for Listing of Importers of Medical Devices: GN-07. Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 17, Jul. 2007. Page 16 of 18

CABs are recognized by MDCO under MDACS upon the CABs meeting specific requirements and assessment criteria. A CAB conducts conformity assessment to determine whether a medical device meets the Essential Principles of Safety and Performance of Medical Devices under GN-01 12 and issues conformity assessment certificates to manufacturers whose devices meet such Essential Principles. Furthermore, CABs may also play a role in LM listing by being a LM s quality management system (QMS) certifying body. CABs serve as a cornerstone in the medical device and LM listing schemes and interact extensively with MDCO, Local Responsible Persons and LMs. We realize that there are only two CABs presently listed and are concerned with: a. The insufficient number of CABs who will be in demand for conformity assessment and QMS certification b. The lack of diversity in CABs operating under MDACS. Thus, HKMHDMA advises DH to actively recruit more qualified CABs to participate in the Regulations. 20. HKMHDMA recommends the Regulations to define if and how a Local Responsible Person (LRP) may succeed a previous LRP s responsibilities MDACS provides in the application of Class II to IV device listing, that an LRP supported by the device manufacturer be named. Among the obligations of the LRP are communication between the users, manufacturer, importers and the Government; application for device listing, maintenance of distribution records, complaint handling, device maintenance and services arrangements, tracking of specific devices, responding to product alerts, modifications and recalls and managing reportable adverse incidents. 13 12 Overview of the Medical Device Administrative Control System GN-01. Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 1, Sep. 2005. 13 Overview of the Medical Device Administrative Control System GN-01. Department of Health, The Government of the Hong Kong Special Administrative Region of the People s Republic of China. 1, Sep. 2005. Section 4. Page 17 of 18

i. Most medical devices on sale in Hong Kong are imported. Thus, it is anticipated that most LRPs are importers or agents of manufacturers. It is foreseeable that the commercial arrangement between a manufacturer and its importer agent may change over time. If an existing importer ceases to be supported by the manufacturer as the LRP due to a terminal of relationship, it is unclear how post-market obligations of the LRP in relation to previously marketed devices can continue to be met. ii. iii. It has been indicated that Regulations may allow assumption of LRP responsibilities based on agreement between manufacturer, present and succeeding LRPs. HKMHDMA advises the assumption of LRP responsibilities to be clarified in Regulations. Page 18 of 18