Updates on Singapore's Transition to Medical Device Regulation
Singapore Medical Device Market Background
With the highest per capita GDP (at current exchange rates: $36,500) after Japan in Asia, Singapore should not be an overlooked destination for medical devices. In fact, the IMF places Singapore fourth in the world for per capita GDP (adjusted for PPP: $50,500), which is above Japan, the U.S., and the U.K. These estimates demonstrate the level of wealth in Singapore.
Overall, Singapore's economy is growing strongly. Despite a small negative growth rate in 2009, the Economic Development Board of Singapore projects a 13%-15% growth rate for 2010. This growth is significantly higher than China's estimated 9% economic growth in 2010. The current GDP is approximately $182 billion (at current exchange rates), which is roughly half the economic size of Sweden or Poland.
Another important market indicator is health expenditure, which specifies the amount of money available to be spent on medical devices. Singapore's per capita annual health expenditure is over $1200. Once again, Singapore ranks very close to the top in Asia for health expenditure per capita.
The medical device market is valued at approximately $575 million. New health infrastructure and talent development initiatives are underway to continue this market growth.
Pre-Health Products Act 2007
Before Singapore's Health Products Act 2007, most medical devices did not fall under governmental Singapore medical device regulation. The Drugs Regulatory Control, however, covered eye lubricants, joint lubrication gels, and a few other medical device categories. The Drugs Regulatory Control listed these medical devices as drugs, which were classified into drug risk classes. From August 1, 2010 onwards, all of these medical devices need to be re-registered under the Health Products Act 2007 guidelines using the online Medical Device Information and Communication System (MEDICS) interface. MEDICS is the medical device registration system (http://www.hsa.gov.sg/publish/hsaportal/en/services/medics.html).
Health Products Act 2007: Implementation Schedule
Since November 1, 2007, the Singapore's Health Sciences Authority (HSA) started implementation of its Health Products Act 2007. The Act comprehensively regulates all medical devices (including in vitro diagnostics) and cosmetic products. Implementation of this Singapore medical device regulation has been carried out in phases:
Phase 1) November 1, 2007 onwards
Post-marketing duties and obligations (maintenance of distribution and complaint records, reporting of field safety corrective action, prohibition against false and misleading advertisements)
Phase 2) November 1, 2008 - April 30, 2010
Preliminary commencement of dealer's licensing and product registration
part a) May 1, 2010 - July 31, 2010
Product registration more fully implemented (Common Submission Dossier Template (CSDT) submission required for product registration, etc.)
part b) August 1, 2010 - July 31, 2011
Fuller implementation of all dealers' licenses, and almost all class C and D medical devices need to be registered with HSA
part c) August 1, 2011 onwards
Final transition to full implementation of all dealers' licenses, and all classes of medical devices need to be registered with HSA
On August 1, 2010, HSA executed the most important part of the Act's final phase. Medical device companies had to abide by many of the new product registration and licensing guidelines.
As of August 1, 2010, the following Singapore medical device regulationguidelines are now enforced in Singapore:
- All class C and class D medical devices (classes are discussed later) need to be registered with HSA to be supplied, except those licensed under Radiation Protection Act (Cap. 262)
- Applications for importer's, manufacturer's, and/or wholesaler's licenses with HSA are required by anyone managing medical devices
- Maintaining records of import and supply
- Maintaining records of complaints
- Reporting of defects and adverse effects to HSA
- Notifying HSA concerning product recalls
- Prohibition against false or misleading advertisement
By August 1, 2011, the following additional updates will be enforced:
- All medical devices under Radiation Protection Act (Cap. 262) need to be registered with HSA
- All class B medical devices need to be registered with HSA
- All class A medical devices need to be registered with HSA, except those listed for exemption (e.g. adhesive bandages, cotton balls, stethoscopes, etc.)
By August 1, 2011, all medical devices will need to be registered with HSA before supply unless they are for clinical trials, are "œcustom made" medical devices, and/or are class A devices on the exemption list.
Key Product Registration Issues
The only accepted medical device registration application format in Singapore is the ASEAN Common Submission Dossier Template (CSDT). Singapore is the first country in ASEAN to make such extensive use of this application format. The CSDT draws significantly from the Global Harmonization Task Force's Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED). All registration documents must be in English. This new Singapore medical device regulation went into effect May 1, 2009.
The first step in product registration is to classify the medical device. The system includes four classes from A to D, with A being the lowest risk and D being the highest risk.
Examples of the classifications are as follows:
- low risk class A devices: surgical retractors and tongue depressors
- low-moderate risk class B devices: hypodermic needles and suction equipment
- moderate-high risk class C devices: lung ventilators and bone fixation plates
- high risk class D devices: heart valves and implantable defibrillators
Class A Medical Device Registration Process
The class A registration application process is a simple four step procedure: online application submission through MEDICS, screening by HSA (ensure all necessary parts are present), review by HSA, and finally a "œregulatory decision.
A class A medical device application is shorter than that for class B, C, and D devices. It consists of two parts: product information and importer information. The class A medical device application calls for product information in the form of: original English copies of labels and packaging, instructions for use, patient information leaflet (if applicable), and promotional materials; sterilization validation report (if applicable); certification on medical device metrology (if applicable); and certification to electrical safety standards (if applicable). Basic importer information such as name, address, and contact number must also be submitted.
Class B, C, and D Medical Device Registration Process
For class B, C, and D medical devices, two evaluation routes are available: abridged and full. If the product has been evaluated and approved in at least one of the GHTF founding members (Australia, Canada, E.U., Japan and U.S.), it is likely eligible for the abridged evaluation. Abridged routes allow summaries for certain sections in the registration application. The product must, however, be the exact same (i.e. identical packaging, labeling, etc.). All other class B, C, and D medical devices must undergo the full evaluation route: online application submission through MEDICS, screening by HSA (ensuring all necessary parts are present), acceptance notice by HSA, review by HSA, and finally an evaluation decision and "œregulatory decision."
The CSDT includes sections on: essential principles and evidence of conformity, device description, intended uses, indications, instructions of use, contraindications, warnings, precautions, potential adverse effects, alternative therapy, materials, other relevant specifications, other descriptive information, summary of design verification and validation documents, pre-clinical studies, software verification and validation studies, clinical evidence, results of risk analysis, samples of labeling, and manufacturing information.
Singapore Medical Device Register
All approved medical device registrations will be recorded on this list (http://eservice.hsa.gov.sg/medics/md/mdEnquiry.do?action=getAllDevices).
Singapore now uses the overarching category of "dealer" to refer generally to "manufacturer," "importer," and "wholesaler.” These agents need corresponding license to deal with medical devices. The manufacturing license is required for medical device companies manufacturing in Singapore. The importer license is required for companies importing medical devices from outside of Singapore. The wholesale license is required for companies supplying medical devices by wholesale within Singapore. The old terms of "distributor" or "export-only" to refer to individuals or licenses are now obsolete.
All dealers need appropriate licensing by August 1, 2010, except those dealing with medical devices under Radiation Protection Act (Cap. 262) and/or those dealing with import/export of medical devices for clinical trials.
Manufacturer License Application: Supporting Documents
The manufacturing license applicant needs to include a list of class A exempted medical devices manufactured and a quality management system certificate in the application.
Importer License Application: Supporting Documents
The importer license applicant needs to include a list of class A exempted medical devices imported and a Good Distribution Practice for Medical Devices (GDPMDS) Certificate in the application.
Wholesale License Application: Supporting Documents
The wholesale license applicant needs to include a Good Distribution Practice for Medical Devices (GDPMDS) Certificate in the application.
Medical device companies will need to follow these new Singapore regulations to be successful there. Singapore medical device regulations are normally strictly enforced.
Ames Gross (pictured to the right) is president and founder of Pacific Bridge Medical, a Bethesda, MD-based consultant firm that helps companies doing business in the Asia market. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988 and PBM helped hundreds of medical companies with business development and regulatory issues in Asia.
Arthur Chyan is an associate with Pacific Bridge Medical. He is fluent in Chinese and Japanese and works on consulting projects and research.