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Singapore’s HSA Removes Classification and Grouping Inquiry Option
Published on: April 6th, 2022
Manufacturers Referred to HSA Guidance and Online Tools
Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents. Previously, license holders could contact the HSA and confirm the strategy prior to submitting application(s) for borderline products and/or products with complex packaging options. The HSA has long lead the industry, and region, in providing clear and effective guidance. In recent years, they’ve released several new online tools and guidance documents to better assist manufacturers evaluate their own products.
Please find a list of online tools and resources provided by the HSA and feel free to contact Asia Actual for additional assistance if needed. More information on the registration requirements in Singapore can be found here.
|Application status||Check the MEDICS application status via:
|Registration and licensing requirements||Use the HSA’s tools and guides to help classify products and/or obtain the relevant regulatory requirements:|
|Product classification||Use the following HSA tools and guides to help classify products:|
|Risk classification||Use the following tools and guides to help classify medical device:
You are also encouraged to reference the Singapore Medical Device Register (SMDR) or R.O.S.E. and compare the risk classification of locally registered medical devices with similar intended use(s) and/or intended purpose.
All supporting documents which adequately validate the statements you have selected in the risk classification tool must be submitted to substantiate the proposed risk classification for your pre-market and/or change notification application.
|Grouping options||The HSA provides also provides tools to help companies group their medical device applications:
All supporting documents which adequately validate the statements selected in the grouping tool must be submitted to substantiate the proposed grouping for your pre-market and/or change notification application.
How to Update Company or Applicant Details
Companies that only need to change their name or address and not the Unique Entity Number (UEN) can do so through the MEDICS and the Change of Business Information. There are no fees for these amendments but these changes will affect existing registrations and any pending applications affected.
New legal entities with different UENs will need to apply for a new CRIS account and then transfer the existing device listings under the new CRIS account. Pending applications will need to be withdrawn and new applications will need to be submitted under the new CRIS account. This new entiry will then need to apply for a new dealer’s license as all dealer’s licenses related to the former UEN will no longer be valid and a license cancellation will need to be filed.
More information on the regulatory process can be found here and click here for the latest HSA fees.
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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in Singapore. Contact Asia Actual today if you have questions or need support importing medical products into Singapore.