1. Introduction of Regulatory System on Medical Devices
1.1 The Consumer Council strongly supports the implementation of a regulatory system on medical devices for the reasons below:
1.2 Over the years, the Consumer Council has tested and revealed safety / quality problems of some medical devices. For example, problems were identified in the Council's tests on the water-leakage and breakage resistance of condoms, inaccuracy and inconsistency of the performance of thermometers, blood glucose meters and blood pressure monitors.
1.3 At present there is no specific legislation to regulate the importation or sale of medical devices in Hong Kong except for those containing pharmaceutical products or radioactive substances. If other jurisdictions close to Hong Kong have regulatory systems for medical devices which we do not have, HKSAR could become the easy dumping ground of poor quality or dangerous medical devices.
1.4 Hong Kong consumers have higher health awareness after the SARS epidemic as evidenced from the increasing statistics of consumer enquiries and requests for testing of health related products e.g. facemasks and personal air purifiers. On the other hand, medical devices have become more user-friendly with advances in technology and easily available to consumers. Yet they should not be regarded as purely consumer goods. Regulations would be important to monitor the safety and quality of these products.
2. Principles of Regulation
2.1 The Council agrees with classifying medical devices into four classes according to the degree of risk as in the recommendations made by GHTF (Global Harmonization Task Force). The Council also supports that the level of regulatory control should increase with increasing degree of risk.
3. Scope of Control
3.1 Pre-market Control
3.1.1 The Council noted that to shorten the time taken for assessment, one of the registration options proposed is for the applicants to submit evidences of product safety, effectiveness and quality if their products have already been approved for marketing in specified GHTF founding member countries or regions. The Council agrees that experience gained from GHTF founding members countries serves as good reference for the prospective regulatory system in Hong Kong. However, the Council reckons that it would be vital for the regulatory authority to ensure that the medical devices to be sold in Hong Kong should be identical, in terms of quality, safety, design and method of use etc, with those already available in GHTF founding members. It is understood that monitoring the compliance of these equipments would mean a heavy burden to the Authority. The Council therefore suggests that the applicants of medical devices should be required to make declaration during the registration process to the effect that products under application are identical with those which were approved for marketing in GHTF founding members countries. Hence the onus of proof lies with the applicant and it would ease the burden of the regulatory authority in proving the authenticity of the submitted evidence.
3.1.2 Classification of medical devices should be subject to review on a regular basis. Both suppliers and consumers / end users should have the right to appeal for the classification.
3.1.3 Some manufacturers may produce different versions of the same medical device for different ethnic groups. Different versions should be registered separately so that consumers can purchase the versions that are suitable for most people in Hong Kong.
4. Control in use and operation of selected high risk medical devices
4.1 The Council is concerned about the unnecessary harm and complications arising from the improper use of medical devices. In the absence of control arrangements, persons without proper training and qualifications may also use devices originally intended for use of medical professionals. An example is the use of medical lasers or intense pulse light equipment by unqualified personnels in beauty parlours.
4.2 According to the Consumer Council statistics, a total of 36 complaints on the use of medical lasers by non-medical personnel in beauty parlours were received in 2001-2002. Of these cases, 3 were relating to complaint about allergic reactions and 6 about scarring or burns after laser treatments.
4.3 The Council supports to limit the use or operation of higher risk medical devices to specified personnel, for example, the use of laser equipments intended for medical therapy.
5. Post-market Control
5.1 For High Risk Level Devices such as the ones classified as class III and IV, the suppliers should be required to provide sufficient training for end users, to take precautionary measures to minimize potential health hazards associated with their use and to collect data on the performance and safety of the devices.
5.2 In the absence of compulsory reporting system of adverse incidents, local health facilities rely heavily on overseas official information sources. To carry out timely intervention, mandatory reporting of serious adverse problems is essential to ensure the safe use of the devices. The Council recommends to set up a local hotline for case reporting to ensure the smooth operation of the adverse reporting and surveillance system, so that remedial actions can be taken in a timely manner.
6. Time Frame
6.1 The Council noted that the control system will start with the listing of high risk (Class IV) medical devices, their importers and manufacturers in 2004. After review and evaluation, listing of Class III and Class II devices etc will then follow in stages.
6.2 While the Council understands that the regulatory authority needs to prioritize the issues by their urgency, it should not lose sight of the potential danger associated with the current situation where there are no controls on certain medical devices like laser equipment and the qualification of the operators. From the proposed time-table, it is envisaged that the operators of laser equipment in beauty centres would not be regulated before year 2006. This would mean a very long time before consumers get their proper protection over the use of beauty service by laser equipments. The Council urges the government to speed up its control on safety of laser equipment as well as the qualification of operators.
