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. These places also lead other nearby, much larger Asian markets: Singapore strongly influences the Association of Southeast 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.
MEDICAL DEVICE REGULATIONS IN SINGAPORE
Overview
Singapore is the wealthiest, most developed member of the Association of Southeast Asian Nations (ASEAN), with a gross domestic product or GDP (PPP) of $228 billion 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. Singapore’s estimated 2007 GDP per capita (PPP), almost $50,000, is second only to Brunei’s in Asia.
The medical device market in Singapore stood at $178 million in 2006 and is estimated to reach $276 million by 2011. With its medical device imports, strong economy, and aging population, Singapore’s medical device market 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. Since a restructuring in August 2008, it is made up of three professional groups that oversee the three major functions of the HSA:
- The Health Products Regulation Group regulates health products, i.e., drugs, medical devices, etc. It contains the Center for Medical Device Registration (CMDR), which conducts mandatory safety registration, certification, and 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.
Since 2002, Singapore has had a voluntary medical device registration system, but the HSA has recently implemented a plan for standardizing and regulating medical devices. While the phases of the plan have been scheduled for specific years, the schedule may shift in the future.
In 2007, the Health Products Act was passed, allowing the HSA to conduct mandatory product registration and regulate the supply, distribution, manufacturing, import, and advertisement of health products. Shortly afterwards, Phase 1 of the HSA’s implementation plan began, requiring device firms to report product defects and adverse events to the HSA. Companies are also required to notify the HSA before the initiation of a product recall. Additionally, false or misleading advertisements of medical devices were prohibited.
Beginning in the fourth quarter of 2008, in Phase 2, the HSA will begin to license parties dealing in medical devices, including manufacturers and distributors. Also, product registration applications will be accepted for all medical devices in preparation for this becoming a requirement.
In the second quarter of 2010, Phase 3 will prohibit unlicensed parties from manufacturing, importing, and wholesaling medical devices. It will also prohibit the sale of unregistered Class B, C, and D medical devices (please see below for the details of Singapore’s classification system).
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 the HSA.
Medical Device Classification
Medical devices are classified in Singapore based on the risk associated with the intended purpose of the device. The product’s owner is responsible for determining the risk classification, while the registrant verifies upon product registration. The following factors influence device classification: how long the device is in contact with the body; the invasiveness of the device; 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 devices, such as surgical retractors and tongue depressors; 30% are Class B and C devices, such as hypodermic needles and lung ventilators; and 10% are Class D devices, such as heart valves or implantable defibrillators.
Product Registration
Registered devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available online (http://www.hsa.gov.sg/publish/hsaportal/en/services/medics/smdr.html). Annual renewal of product registration is required as the listing expires every September 30th. 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. This must be a Singaporean company registered with the Accounting and Corporate Regulatory Authority (ACRA). The registrant acts as the main contact person for the HSA, and must register with the HSA 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, the 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 pre-submission consultation session with the HSA. A dossier should be submitted to the HSA one month before the consultation process so that the HSA can review it in advance before advising the registrant.
To register a Class A medical device, it will not be required to submit a full dossier for review. Companies registering Class A devices will only be required to submit the product registration application to be listed on the SMDR. The HSA will simply review the application to determine whether the device is correctly classified and whether the intended use is appropriate for the design of the device. After verifying the risk classification and the product claims, the HSA will list the medical device on the SMDR. Product owners of Class I devices will also have a legal obligation to keep complete distribution and complaint records, as well as notify the 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 ten ASEAN countries by 2015, meaning that a dossier accepted by the 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. It must also have attached copies of all labeling, certificates, and reports referenced within the CSDT.
After a dossier is submitted, the HSA will initially screen it for correct classification, format, and completeness. If the HSA raises any issues during this process, the registrant must reply within 30 days. Once any of those issues are clarified, the dossier will be accepted for full review. The HSA’s evaluation of accepted dossiers normally takes 60 days. If the registrant does not meet the deadline for clarifying any issues, the dossier will be rejected. If the 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 U.S., may make an “abridged” submission. Although the required content such as submission is the same, the review process is simpler. All technical documentation, including packaging, labeling, instructions for use, and indications for use, that were approved by a GHTF country can be submitted for product registration in Singapore.
The registrant must notify the 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, then the HSA must give approval before the changed device can be sold in Singapore.
MEDICAL DEVICE REGULATIONS IN HONG KONG
Overview
On a per capita basis, Hong Kong is the third wealthiest country in Asia after Singapore and Brunei. Hong Kong has a population of 6.9 million people and a $293 billion GDP (PPP) in 2007. In comparison, Belgium has a population of about 10.7 million people, and it had a GDP (PPP) of $377 billion in 2007.
Hong Kong is now a part of China, but as a special administrative region, Hong Kong has its own medical device regulations separate from China. 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 there will be stricter requirements for medical devices in the future.
Regulatory Authority
The Department of Health (DOH) is the main health authority in Hong Kong. Under the DOH, the Medical Device Control Office (MDCO) regulates medical devices. Established in 2004, the MDCO consists of the Medical Device Registration Section and the Post-Marketing Surveillance Section.
On November 26, 2004, the 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 recommendations of the GHTF for medical devices. While the MDACS listing system is currently voluntary, it is intended to familiarize manufacturers and distributors with mandatory requirements that are currently in development.
In November 2004, Phase I 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 make and model of the device, the contact details of the manufacturer, and the contact details of the Local Representative Person (LRP). This list is available to the public on the MDCO website (www.mdco.gov.hk).
In November 2005, Phase II expanded the listing to include medium-risk (Class II and III) medical devices.
In October 2006, Phase III began the Conformity Assessment Body Recognition Scheme. In this phase, the MDCO began to recognize Conformity Assessment Bodies (CAB) that can perform conformity assessment showing that a device has fulfilled MDACS requirements.
In March 2007, Phase IV began the listing of local manufacturers. Requirements for manufacturers include ISO 13485 certification and adequate Quality Management Systems (QMS).
In July 2007, Phase V 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, the MDCO can still intervene if they feel that a marketed device is unsafe or unfair to the Hong Kong population. In these cases, the device is not taken off the market, but the MDCO can write a letter to hospital authorities so that hospitals and doctors will not purchase it.
Medical Device Classification
Medical devices in Hong Kong are classified as I-IV according to the risk level associated with their intended use. Class I devices are low-risk medical devices, such as bandage and dressing. Class II devices are medium-low-risk devices, such as suction pumps and gastroscopes. Class III devices are medium-high-risk devices, such as orthopedic implants and medical lasers. Class IV devices are high-risk devices, such as prosthetic heart valves and implantable cardiac pacemakers.
The 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. The 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 non-viable 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 the MDCO is the Local Representative Person (LRP), who must be a locally-registered entity. The LRP must be either the manufacturer of the device or 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 the MDCO, e.g., making documents referenced in the application available for inspection. After the device is listed, the LRP is responsible for the marketing and post-market 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 U.S., 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 such a checklist which was part of a prior EU approval, then they may submit that document instead with a declaration that the checklist also satisfies MD-CCL requirements. Medical devices that received market approval from a GHTF founding member on or before December 31, 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 timing can vary. After evaluation, the application will be rejected, approved, or conditionally approved. Conditional approvals will specify special conditions, such as requiring specific post-market 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, post-market surveillance system, Summary Technical Documentation (STED), and Declaration of Conformity, all based on MDACS standards. Conformity assessment will be performed not by the MDCO but by an independent Conformity Assessment Body (CAB). All CABs must be certified by the MDCO to operate.
CABs will have some discretion to simplify or enhance the conformity assessment requirements depending on 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, though they will still 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 assessment.
Even after receiving approval, a medical device may be permanently or temporarily delisted at the discretion of the 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.