This article was also published on Medical Device Summit
The medical device market in Singapore reached $535 million last year, despite its small land area and a population of only 4.7 million. Singaporeans’ strong demand for better healthcare creates an excellent market for foreign medical device companies, who supply more than 85 percent of the country’s devices. Leading importers include the US, Germany and Japan.
As long as foreign companies understand key requirements, medical device registration in Singapore is not difficult. Several rules to ease market access were enacted in 2012, and more are expected for the rest of 2013. Companies that keep up with the new rules should find registration both quicker and less expensive.
MEDICAL DEVICE REGISTRATION
A decade ago, most medical devices did not require registration in Singapore. However, that changed after 2007, with the passage of Singapore’s Health Products Act.
Like many regulatory bodies, Singapore’s Health Sciences Authority (HSA) uses a risk-based system to classify and register all medical devices. The HSA recognizes four separate classes of medical devices:
- Class A (low risk devices like tongue depressors)
- Class B (low-moderate risk devices like hypodermic needles)
- Class C (moderate-high risk devices like lung ventilators)
- Class D (high risk devices like heart valves)
Generally, devices already registered with key international regulatory agencies (the US FDA, the EU, Health Canada, Australia’s TGA and the Japanese PMDA) can be registered in Singapore under an equivalent classification. The product owner determines risk classification, and the HSA then approves or modifies the requested class. If the medical device has already been approved by another regulatory agency, the HSA rarely changes its risk classification.
To register a device in Singapore, the product owner must first appoint a local registration agent. The local registration agent can be the product owner’s Singapore office, a Singapore-based distributor or an independent third-party entity, as long as it is registered with the Accounting and Corporate Regulatory Authority (ACRA). The local registration agent is responsible for submitting all registration documents and answering all HSA inquiries regarding the product (both before and after approval). After approval, the local registration agent holds the product license in Singapore.
Many product owners prefer to use a third-party entity — rather than a local distributor — as their local registration agent. This ensures that the distributor will not maintain control over the product license, if the product owner decides to find a new distributor in Singapore.
All registration activities are handled electronically. The local registration agent submits all registration documents online using an electronic portal called the Medical Devices Information and Communication System (MEDICS). If the product owner does not want to provide sensitive information directly to their registration agent, they can upload documents directly to MEDICS.
All medical devices in Singapore must be registered, with only one exception: Class A non-sterile devices. Class A sterile devices take 30 working days to register. Class B, Class C and Class D medical devices may be registered via four major channels — full evaluation, abridged evaluation, expedited evaluation and immediate evaluation.
Full evaluation takes place only for new products that have not been approved by an international key regulatory agency. This process is rarely used. Instead, foreign medical device companies typically use the immediate, expedited and abridged evaluation channels.
Immediate registration is available only to Class B medical devices that have been approved by at least two independent reference agencies and marketed for three years without safety issues. Registration takes between one and two months, and costs US $1,131. Expedited registration is available for Class B devices that have been approved by at least one agency and marketed for three years without safety concerns. Registration is supposed to take 60 working days (though it typically takes between three and five months), and costs US $1,131. Abridged registration is available for Class B devices that have been approved by one independent reference agency. Registration takes between five and seven months and costs US $1,858.
Previously, only two registration evaluation routes were available for Class C and Class D devices — full and abridged. But beginning in January 2013, a new expedited evaluation channel is available for devices in both classes. Class C medical devices that have been approved by two or more independent reference agencies can qualify for expedited evaluation. So can Class C medical devices that have been approved by one agency and marketed for three years with no safety issues.
The expedited channel reduces average turnaround time for Class C medical devices from 160 to 120 working days. According to the HSA, 75 percent of existing Class C applications will be eligible. The cost for expedited evaluation is US $2,828, while the cost for abridged evaluation is US $3,232.
In addition, Class D medical devices with approval from two or more independent reference agencies are also eligible for expedited evaluation. Average turnaround time has gone from 220 to 180 working days, and about 50 percent of existing Class D applications are considered eligible. The cost for expedited evaluation is US $4,767, while the cost for abridged evaluation is US $5,010.
Medical device manufacturers that have already gotten approval for their device from the EU will find that 90 percent of required registration paperwork is identical. All submissions must be made in English, and they must be made according to the ASEAN Common Submission Dossier Template (CSDT). Sample components of a CSDT dossier include:
- Description of the medical device and its features
- Intended use, and indications
- Instructions for use
- Warnings, precautions, and potential adverse effects
- Alternative therapies
- Relevant data and summaries of test evaluations, such as biocompatability
The HSA can be more lenient with companies that have registered their devices in other developed nations. To avoid delays, the product owner should pick one key agency that has already approved the device, and submit paperwork in accordance with that format. For example, device quality information including packaging, labeling and instruction, intention, and indication for use should be the same as that approved by the reference agency.
Product owners must undergo a simple renewal process annually. They must also notify the HSA of any changes in their manufacturing process. Changes that are of an administrative nature (moving to a new manufacturing site, for example) can be submitted to the HSA, while changes of a technical nature (for example, a change in product design) must be submitted to the HSA along with the required supporting documentation.
Medical device manufacturers may also apply to bring their product into Singapore through a special “authorization route.” Such routes are meant for circumstances like trade shows involving the import — but not general supply — of a specific medical device.
SUPPLY AND DISTRIBUTION
To import and distribute a medical device in Singapore, the local agent must ensure that two licenses are in place: the importer’s license and the wholesaler’s license. If the device is made in Singapore, the local manufacturer is also responsible for securing a manufacturing license. Only sites with a Quality Management System Certificate (ISO 13485:2003) are eligible.
The distribution agent can be an independent local third party, a local distributor or the Singapore office of the product owner. Whoever imports the device must have an importer’s license, and whoever sells the device must have a wholesaler’s license. For Class B, C and D medical devices, both licenses require certificates in Good Distribution Practice for Medical Devices (GDPMDS). In the case of Class A medical devices, importers and wholesalers need only to submit QMS assessment forms and annual QMS compliance declarations.
POST MARKET SURVEILLANCE
Local distribution agents for medical devices must maintain detailed records of complaints for five years. They must also keep distribution records (such as control numbers and dates of shipment) for the longer of two time periods — the estimated useful life of the medical device, or two years after device shipment. Finally, either the local registration agent or the distribution agent must report all adverse events and field safety corrective actions to the HSA within specified time periods. For adverse events that pose serious threats to public health, a report is required within 48 hours.
Singapore’s HSA is a relatively young organization. Since its founding in 2001, it has relied largely on the internationally-recognized guidelines of the Global Harmonization Task Force (GHTF). But as the HSA has matured, it has developed regulatory requirements more compatible with the local market.
Most recently, the HSA has implemented regulations to speed up registration for Class C and Class D medical devices. These devices account for roughly 30 percent of Singapore’s medical device market. The other 70 percent of the market — Class A and Class B medical devices — saw evaluation processes speed up in April 2012. At that time, the HSA created the “immediate” channel for Class B devices, and exempted non-sterile Class A devices from registration.
In the future, the HSA is likely to continue enacting changes that tighten up the regulatory process.
One such possibility is more regulatory controls for medical devices used in clinical trials in Singapore. The HSA is already debating such requirements in a new piece of draft legislation, the Health Products (Clinical Trials) Regulations. Set to start in 2013, the regulations would apply to higher-risk devices, but would exclude Class A and B medical devices and non-invasive, non-confirmatory, in-vitro diagnostic products.
Foreign medical device companies should regularly check for updates to Singapore’s medical device registration, import and distribution requirements. For now, they should expect HSA to continue with modifications that will result in lower registration costs, less onerous requirements, and quicker access to Singapore’s medical device market.