In the huge expanse of Asia, Singapore and

New Medical Device Regulation 16 February 2009

By Ames Gross In the huge expanse of Asia, Singapore and Hong Kong are small places. However, after Japan, they are among the most advanced medical markets in the region. They also lead other nearby, much larger Asian markets: Singapore strongly influences the Association of Southeast Asian Nations (ASEAN) and Hong Kong strongly influences China. While these two markets have had little medical device regulation in the past, they are both introducing new requirements. Singapore Overview Singapore is the wealthiest, most developed member of ASEAN, with a gross domestic product, or GDP (based upon purchasing power parity (PPP)), of $228 billion (US) in 2007. The Singaporean population was about 4.6 million in 2008, up from about 4 million in 2000. In contrast, Taiwan s population is four times Singapore s while its GDP is only three times Singapore s. Among Asian nations, Singapore s estimated 2007 GDP per capita (PPP), almost $50,000, is second only to Brunei s. The medical device market in Singapore stood at $178 million in 2006 and is estimated to reach $276 million by 2011. With its dependence upon imports, strong economy and aging population, Singapore will continue to draw Western companies. While Singapore now has a voluntary regulatory environment, new regulations being implemented will require registering all medical devices by 2011. Regulatory Authority Singapore s chief medical regulatory body is the Health Sciences Authority (HSA), founded in April 2001. Following a restructuring in August 2008, it now comprises three professional groups that oversee the three major functions of the HSA: The Health Products Regulation Group regulates drugs, medical devices, etc. It includes the Center for Medical Device Registration (CMDR), which conducts safety registration, certification and s in Singapore and Hong Kong Regulatory Focus 17

inspection for medical devices. The Applied Sciences Group provides forensic medical and scientific expertise to assist in public health and justice issues. The Blood Services Group oversees Singapore s blood supply. Singapore has had a voluntary medical device registration system in place since 2002, but HSA recently implemented a plan for standardizing and regulating medical devices. While the phases of the plan have been scheduled for implementation in specific years, this schedule may shift in the future. In 2007, the Health Products Act was passed, allowing HSA to conduct mandatory product registration and regulate the supply, distribution, manufacturing, import and advertisement of health products. Shortly afterward, phase 1 of HSA s implementation plan began, requiring device firms to report product defects and adverse events to the authority. Companies are also required to notify HSA before initiating a product recall. Additionally, false or misleading advertisements of medical devices are prohibited. Beginning in the fourth quarter of 2008, in phase 2, HSA will begin to license parties dealing in medical devices, including manufacturers and distributors. To prepare for this requirement, product registration applications will be accepted for all medical devices. In the second quarter of 2010, phase 3 will prohibit unlicensed parties from manufacturing, importing or wholesaling medical devices. It will also prohibit the sale of unregistered Class B, C and D medical devices (see details of Singapore s classification system below). In the second quarter of 2011, the sale of unregistered Class A medical devices will also be prohibited. Thus, by the second quarter of 2011, all medical devices will need to be registered in Singapore, and all dealers, including manufacturers and distributors, will need to be licensed with HSA. Medical Device Classification Medical devices are classified in Singapore based upon the risk associated with their intended purpose. The product s owner is responsible for determining the risk classification, which the registrant (defined below) verifies upon product registration. HSA will make an initial review to determine whether the device has been correctly classified. However, it is not clear what the authority will do if the classification is incorrect, whether it will reject the application or change the classification itself. The following factors influence device classification: how long the device is in contact with the body; the device s invasiveness; whether the device delivers medicinal products or energy to the patient; whether the device is intended to have a biological effect on the patient; and whether the device has local or systemic effects on the body. There are four risk classifications of medical devices in Singapore: Class A, low risk; Class B and C, medium risk; and Class D, high risk. Of the 400,000 types of medical devices in Singapore, 60% are Class A, e.g., surgical retractors and tongue depressors; 30% are Class B and C, e.g., hypodermic needles and lung ventilators; and 10% are Class D, e.g., heart valves or implantable defibrillators. Product Registration Registered devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available online (www.hsa.gov.sg/publish/ hsaportal/en/services/medics/smdr.html). Annual renewal of product registration is required as the listing expires each year on 30 September. Renewal notices are sent to the registrant on a yearly basis. Under Singaporean standards, the registrant is defined as the party that applies for and obtains product registration for a medical device on behalf of the manufacturer. This must be a Singaporean company registered with the Accounting and Corporate Regulatory Authority (ACRA). The registrant acts as the main contact person for HSA, and must register with the authority in order to use the online Medical Device Information and Communication System (MEDICS) to submit product registration applications. The product owner is defined as the manufacturer, or the party who named the device, and must issue a Letter of Authorization to the registrant for each product registration application submitted. Before a device dossier or product registration application is submitted, HSA must initially verify that the product qualifies as a medical device under the Health Products Act. Once it is confirmed to be a medical device, the application process can begin. If there are specific issues with the dossier or application, the registrant can request a presubmission consultation session with HSA. A dossier should be submitted to HSA one month before the consultation process so the authority can review it before advising the registrant. To register a Class A medical device, submission of a full dossier for review will not be 18 February 2009

required. Companies registering Class A devices will only need to submit the product registration application to be listed on the SMDR. HSA will simply review the application to determine whether the device is correctly classified and whether the design is appropriate for the intended use. After verifying the risk classification and the product claims, HSA will list the medical device on the SMDR. Product owners of Class A devices also will have a legal obligation to keep complete distribution and complaint records, as well as notify HSA of product recalls and adverse events. Companies registering Class B, C and D medical devices must submit a device dossier in the Common Submission Dossier Template (CSDT) format online via MEDICS. The CSDT format will be used in all 10 ASEAN countries by 2015, meaning that a dossier accepted by HSA in Singapore can also be accepted in the same format by all ASEAN regulatory authorities. A dossier in CSDT format must be prepared in English and approved by the product owner. It must include clinical evidence and clearly identified labeling, technical descriptions and instructions. Copies of all labeling, certificates and reports referenced within the CSDT must be attached. After a dossier is submitted, HSA will initially screen it for correct classification, format and completeness. If HSA raises any issues during this process, the registrant must reply within 30 days. Once those issues are clarified, the dossier will be accepted for full review. HSA s evaluation of accepted dossiers normally takes 60 days. If the registrant does not meet the deadline for clarifying issues, the dossier will be rejected. If HSA approves the device dossier, the registrant will then be able to submit a product registration application for listing on the SMDR. Companies with Class B, C and D devices that already have market approval from the founding members of the Global Harmonization Task Force (GHTF), i.e., Australia, Canada, the EU, Japan and the US, may make an abridged submission. Although the required content is the same, the review process is simpler. All technical documentation, including packaging, labeling, instructions for use and indications for use, which were approved by a GHTF country, can be submitted for product registration in Singapore. The registrant must notify HSA if there are any changes to the information given in the application for Class B, C and D medical devices. If significant changes are made to the medical device, HSA must give approval before the changed device can be sold in Singapore. Hong Kong Overview On a per-capita basis, Hong Kong is the thirdwealthiest country in Asia after Singapore and Brunei. Hong Kong has a population of 6.9 million and had a $293 billion GDP (PPP) in 2007. In comparison, Belgium has a population of about 10.7 million, and had a GDP (PPP) of $377 billion in 2007. Although now a part of China, as a special administrative region Hong Kong has its own medical device regulations separate from China s. Having only a few local device manufacturers, Hong Kong imports most of its medical devices. While there has been little legislative control over the import process in the past, recent changes to Hong Kong s medical device registration system suggest that requirements for medical devices will be more strict in the future. Regulatory Focus 19

Regulatory Authority The Department of Health (DOH) is the main health authority in Hong Kong. Under DOH, the Medical Device Control Office (MDCO) regulates medical devices. Established in 2004, MDCO consists of the Medical Device Registration Section and the Post-Marketing Surveillance Section. On 26 November 2004, DOH launched the Medical Device Administrative Control System (MDACS) as a regulatory framework for imported medical devices. The standards in MDACS are adopted from the GHTF recommendations for medical devices. While the MDACS listing system is currently voluntary, it is intended to familiarize manufacturers and distributors with mandatory requirements that are in development. In November 2004, phase 1 of MDACS was implemented to start a listing of high-risk (Class IV) medical devices that meet MDACS standards for safety and quality. The listing includes the device s make and model, manufacturer contact details, and contact details for the Local Representative Person (LRP). This list is available to the public on the MDCO website (www. mdco.gov.hk). In November 2005, phase 2 expanded the listing to include medium-risk (Class II and III) medical devices. In October 2006, phase 3 began the Conformity Assessment Body Recognition Scheme. In this phase, MDCO began to recognize Conformity Assessment Bodies (CABs) that can perform conformity assessment showing that a device has fulfilled MDACS requirements. In March 2007, phase 4 began the listing of local manufacturers. Requirements for manufacturers include ISO 13485 certification and adequate Quality Management Systems (QMS). In July 2007, phase 5 began the listing of medical device importers. Requirements for importers include keeping complete distribution records and having appropriate procedures for product recall and adverse event assessment. Despite the lack of legislative control over the import of medical devices, MDCO can still intervene if it feels a marketed device is unsafe or unfair to the Hong Kong population. In these cases, the device is not taken off the market, but MDCO can write a letter to hospital authorities advising hospitals and doctors not to purchase it. Medical Device Classification Medical devices in Hong Kong are classified according to the risk level associated with their intended use. Class I devices are low-risk, e.g., bandages and dressings. Class II devices are medium-low-risk, e.g., suction pumps and gastroscopes. Class III devices are medium-high-risk, e.g., orthopedic implants and medical lasers. Class IV devices are high-risk, e.g., prosthetic heart valves and implantable cardiac pacemakers. MDCO has adopted the GHTF definition of medical device. Some medical devices that fall under this definition, however, still remain outside the current scope of MDACS. MDCO is currently developing a plan to regulate them. These products include: devices that incorporate human blood, plasma and blood cells, excluding stable derivative devices; products incorporating or derived from transplants, tissues or cells of human or animal origin, excluding products with nonviable animal tissue; in vitro diagnostic (IVD) medical devices; and substances or devices placed in contact with external parts of the body or the oral cavity to clean or improve them for cosmetic purposes. Product Registration The main contact point with MDCO is the LRP, which must be a locally registered entity. The LRP must be either the device manufacturer or an entity approved by the manufacturer to perform the duties of the LRP. The LRP submits the application for listing medical devices and fulfills any requests from MDCO, e.g., making documents referenced in the application available for inspection. After the device is listed, the LRP is responsible for marketing and postmarket procedures, which include keeping distribution records, handling complaints, initiating product recalls, managing adverse incidents and reporting changes. The manufacturer must issue an LRP appointment letter and attach it to each product registration application. Currently, market approval from one of the GHTF founding members (the US, Canada, Australia, the EU and Japan) is required for medical device registration in Hong Kong. Evidence of approval must be attached to the product registration application. Applicants must also attach the Essential Principles Conformity Checklist (MD-CCL) to the product registration application to demonstrate that the device complies with MDACS requirements. This checklist is not exactly the same as the Essential Requirements Checklist of the EU Medical Device Directives, but it is similar. Therefore, if the applicant already has a checklist that was part of a prior EU approval, that document may be submitted instead with a declaration that the checklist also satisfies MD-CCL 20 February 2009

requirements. Medical devices that received market approval from a GHTF founding member on or before 31 December 2004, however, are exempt from submitting an MD-CCL. The completed application form must be submitted with all supporting documents and labeling samples attached. The average evaluation period is about 12 weeks, though this can vary. After evaluation, the application will be rejected, approved or conditionally approved. Conditional approvals will specify conditions to be met, such as requiring specific postmarket surveillance studies. It is possible to appeal rejections or conditional approvals by writing to the secretary of the Medical Device Administration Appeal Committee. A major component of an application is conformity assessment. Conformity assessment covers a product s quality management system, postmarket surveillance system, Summary Technical Documentation (STED) and Declaration of Conformity, all based upon MDACS standards. Conformity assessment will be performed not by MDCO but by a CAB. All CABs must be certified by MDCO. CABs will have some discretion to simplify or enhance the conformity assessment requirements depending upon their experience with a product or its specific characteristics. In general, Class II devices will not need to have an STED submitted as part of quality assessment, although they still will be subject to the other requirements listed above. CABs will need to review the STEDs for Class III and IV devices routinely. Currently, the Hong Kong government does not plan to charge a fee for the listing of medical devices. However, CABs will charge fees to conduct conformity assessments. Even after receiving approval, a medical device may be permanently or temporarily delisted at the discretion of MDCO. This can happen for many reasons, which include jeopardizing public health or safety, failing to comply with MDACS requirements or failing to adequately address a hazard. Author Ames Gross is president and founder of Pacific Bridge Medical. He helps medical companies with business development and regulatory issues in Asia. For more information on Pacific Bridge Medical, please visit our website at www.pacificbridgemedical.com. Regulatory Focus 21