Medical devices require registration with the Health Sciences Authority (HSA) in Singapore before being imported and placed on the market. The Singapore medical device registration process is considered highly transparent and predictable. When applying for product registration in Singapore, applications must be submitted by a local entity that also acts as license holder, or Registrant. The Singapore-based entity must be registered with the Accounting and Corporate Regulatory Authority (ACRA) of Singapore.
Asia Actual Local Regulatory Expert
Principal Consultant, Asia Actual PTE. LTD. (Singapore)
Kenna is one of the most experienced, top level consultants in Singapore with over 500 successful medical and IVD device registrations to her credit. Managing the registration process from start to finish, Kenna will ensure the fastest processing and approval times.
Please reach out to Asia Actual to setup your free consultation.
Successful applications will generate a registration certificate and a listing on the Singapore Medical Device Register (SMDR). The HSA closely follows GHTF guidelines for medical device classification. Cost and time for regulatory review will vary considerably with device classification and reference country registrations.
Medical Device Registration Application Processing Time and Fees
Class D (drug)
(US$ to S$ exchange rate at approximately 1.42)
In addition to the application processing fee, the HSA also charges a one-time application fee of S$500 for all classifications of devices. There is also an annual listing fee of S$35, S$60 and S$120 for Class B, C and D device respectively.
Singapore Medical Device Regulations
Class A Devices
Class A devices do not require pre-market registration but must be listed with the HSA on an annual basis by the licensed importer.
Class B Devices
Class B devices that are registered in one reference country for more than three years each without any “safety concerns”, or two reference countries without any ‘safety concerns” qualify for Immediate Registration (IBR). The Abridged application review process applies to devices that have been registered in one reference country. All other devices undergo a Full registration process.
Class C Devices
Class C devices that are registered in one reference country for more than three years each without any “safety concerns”, or two reference countries without any ‘safety concerns” qualify for Expedited Class Registration (ECR). Specifically excluded from the ECR are Class C hip, knee and shoulder joint replacement and non-bioactive implants (e.g. non-bioactive metal/polymer implants). The Abridged application review process applies to devices that have been registered in one reference country. All other devices undergo a Full registration process.
Class D Devices
Class D devices that are registered in two reference country qualify for Expedited Class Registration (ECR). Specifically excluded from the ECR are Class D:
active implantable devices (e.g. pacemakers, neurostimulators)
Implantable devices in direct contact with the central circulatory system or central nervous system
hip, knee and shoulder joint replacement (e.g. bioactive implants)
devices incorporating a registrable drug in an ancillary role
The Abridged application review process applies to devices that have been registered in one reference country. All other devices undergo a Full registration process.
Quality systems conformity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.
As long as annual listing fees are maintained, and post market vigilance requirements are met, registration do not expire.
Contact Asia Actual for assistance to confirm the cost and time lines that apply to your medical devices. Asia Actual also has experienced, top level consultants in Singapore to manage the application process.
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
https://asiaactual.com/wp-content/uploads/2019/10/sales.png447795Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2019/11/AA-Logo-28.pngBryan Gilburg2019-10-02 18:51:292019-10-02 18:51:314 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA
29 countries in the Asia Pacific sales region do not have a national medical device regulatory review system. Asia Pacific Sales Region – Medical Device Registration Systems: 44 countries 3.74B people $31B device market 29 countries without regulatory review systems 15 countries with regulatory systems 9 countries with reference country approval requirements Note: hospital purchasing […]
https://asiaactual.com/wp-content/uploads/2019/10/sales.png447795Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2019/11/AA-Logo-28.pngBryan Gilburg2015-07-16 21:33:382020-03-23 21:08:45MEDICAL DEVICE SALES IN ASIA