The country’s rapidly aging population and low birth rate have presented it with some unique economic challenges, however. To combat a shrinking native workforce, Singapore offers substantial childcare subsidies to encourage more births. The government has also said that it wants to raise the current retirement age from 62 to 65.
For years, Singapore has had one of the most innovative, competitive and business-friendly markets in Asia. More than 7,000 multinational corporations have offices there, including medical device giants such as Medtronic Inc., which recently expanded its presence there. And while Singapore’s economy is driven largely by exports, it also boasts a strong financial sector and high-growth industries such as healthcare and biotechnology. Singapore’s government invests heavily in infrastructure, research and development, and basic education. The World Bank considers it the easiest country to do business in, and it was recently ranked first in the world for intellectual property protection and lack of corruption.
Singapore’s Health Services Authority (HSA) is an agency constantly on the lookout for the best ways to regulate medical devices. After it was founded in 2001, it relied largely on Global Harmonization Task Force guidelines to establish its regulatory system. Recently, however, the HSA has started modifying regulations to better comply with local market needs. Changes include expedited channels for medical device registration as well as lower fees.
Singapore has four classes of medical devices (A, B, C, D), based on their intended use and risk. Class C and Class D are the highest-risk devices, and together make up one-third of Singapore’s medical device market. In January 2013, the HSA set up an expedited evaluation channel for the registration of Class C and D devices.
Prior to January, just two channels existed for these highest risk medical devices—full and abridged. Now, Class C medical devices approved by at least two independent reference agencies (the Japanese Pharmaceutical and Medical Devices Agency, the U.S. Food and Drug Administration, European Union regulatory authorities, Australia’s Therapeutic Goods Administration and Health Canada) may be registered under the expedited evaluation channel. So too can Class C devices approved by only one agency, as long as such devices have not experienced any safety issues in their last three years on the market.
According to the HSA, nearly three-quarters of existing Class C license holders are eligible for the new expedited evaluation channel. It should reduce average turnaround time from 160 to 120 business days, and save each applicant an estimated $400 (U.S.) per registration.
Class D medical devices approved by at least two independent reference agencies also may qualify for the expedited evaluation channel. The new timeline for Class D medical device registration is 180 business days, rather than 220 days. In addition, the HSA has cut regulatory fees by $242 per application. The agency estimates that half of all existing Class D license holders will be eligible to use the new expedited evaluation channel.
The recent adjustments reflect similar changes made to Class A and B medical device registration, which went into effect in April 2012. According to those changes, Class B medical devices approved by two or more independent reference agencies and then marketed for three years with no safety issues could qualify for immediate product registration approval. Once all paperwork has been submitted, the process takes between one and two months. Class B medical devices approved by at least one agency and then marketed for three years without any safety issues could qualify for an expedited evaluation process of 60 days. Registration and evaluation fees for both expedited and immediate evaluation channels are now a little more than $1,100. This is nearly $1,000 less than the old price. Also in April, Class A non-sterile medical devices were entirely exempted from registration requirements. While Class A sterile medical devices still need to undergo registration evaluation, the HSA has reduced average processing time to 30 business days. Nearly four out of five Class A devices qualified for the exemption.
Starting in January this year Singaporean distributors of Class A medical devices no longer have to carry a Good Distribution Practice for Medical Devices (GDPMDS) to obtain importer’s and wholesaler’s licenses. Instead, they will have to submit only Quality Management System (QMS) assessment forms and annual QMS compliance declarations to the HSA. The reduced requirements for local Singaporean distributors should result in 30 percent less paperwork, and should apply to 10-15 percent of current dealers. On the other hand, dealers now will be subject to HSA post-market surveillance, including on-site audits.
Distributors of Class B, C and D medical devices still need to obtain GDPMDS certificates, which are valid for three years with an annual site audit. HSA regulators say that tighter post-market controls will assure the quality of all medical device dealers and enhance patient safety.
In a draft guidance issued in January, the HSA further added that manufacturers of Class A devices should regularly review their own quality processes and those of their suppliers. They should document every observation and corrective action, and they should draft written agreements with providers to ensure good practices for all outsourced activities.
All foreign medical device companies doing business in Singapore should regularly check for updates to the country’s medical device registration and distribution requirements. The HSA recently enacted many new regulations, and it will likely continue to tighten Singapore’s regulatory system in the future. For example, this year the HSA may implement clinical trial requirements involving investigational medical device products. According to draft legislation, the Health Product (Clinical Trials) Regulations would apply to Class C and Class D medical devices. Lower-risk devices and non-confirmatory, non-invasive, in-vitro diagnostic products would be excluded.
Foreign medical device companies should anticipate more modifications in the regulatory system, which generally will result in less onerous requirements, lower registration costs and faster access to the Singapore medical device market. This is good news for international companies, which supply nearly 90 percent of Singapore’s $500 million medical device sector.
Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical companies doing business in the Asian market (www.pacificbridgemedical.com). A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. Catherine Matacic is a senior associate at Pacific Bridge Medical.