There are two parts to your question: Licensing vs. Registration.
1. For medical device registrations, the applicant is required to obtain a dealer's license from the HSA via MEDICS. This includes the manufacturer, importer, and wholesaler's licenses, as only licensed medical device dealers are allowed to manufacture, import, or sell medical devices in Singapore. Applicants can apply for product registration and the dealer's license at the same time.
2. Registration is depended on who the legal owner of the product is. Registration of the same product by multiple registrants is allowed as overseas manufacturers can appoint more than one distributor in Singapore. Each registrant is required to provide evidence of authorization by the product owner and submit the necessary technical documentation. Each application will be treated as a new application, and no reference to any of the previous application or registered products is allowed. Each registrant is also required to perform all the prescribed duties and obligations under the regulation.
In short, yes, both MAH and OEM can register the products independently in Singapore upon meeting the specific requirements set by HSA.
Regards,
Jo
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Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
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Original Message:
Sent: 05-Jun-2020 08:45
From: Anonymous Member
Subject: Singapore Medical Device Registration
This message was posted by a user wishing to remain anonymous
Thank you for your reply. As a point of clarification, could two companies hold a license for the same device? We know this is possible in other regions of Asia (and the world) but I am not clear on Singapore. In this case, both the distributor and the system OEM want to hold the license on the product. Thank you again for your guidance. It is much appreciated.
Original Message:
Sent: 03-Jun-2020 08:17
From: Anonymous Member
Subject: Singapore Medical Device Registration
This message was posted by a user wishing to remain anonymous
Seeking Assistance on Registration Process in Singapore
The company I work for is relatively new to distribution of products in Asia, specifically Singapore. The company has a contract in place with a distribution partner who will act as both the importer and Market Authorization Holder in Singapore. This company is responsible for completing the registration process in Singapore. Additionally the same products are sold through OEM partners on a global basis. The OEM partners often times register the products as an accessory to their system. Is it possible for both the MAH of record and an OEM to register the products independently in Singapore?