Singapore Medical Devices Regulations

Not just the business capital of Asia, Singapore is one of the best markets for medical device manufacturers coming from different parts of world. So in order to sync with the stringency of regulations and maintaining a flow with harmonization, Health Science Authority has established Singapore as a stringent regulatory market and a member of the ASEAN conglomeration. Use Athreva’s expertise in building your market in Singapore & other ASEAN members.

Medical Device Classification Singapore

Classification and Registration of Medical Devices

In Singapore, it is important to accurately classify the device before initiating the registration activities. The Health Science Agency (HSA) imposes different registration methods for each class based on their complexity and risk associated. Selecting the appropriate method is essential, as it can significantly affect costs, submission requirements, and even approval times.  

Athreva’s experienced regulatory team can help you identify the correct classification and registration route for your device. 

Legal Representative

Athreva can assist you in HSA classifications and registrations

  • Determination of the class of a medical device or IVD
  • Creation of medical device submission document 
  • Assist with technical dossier preparation and CSDT structure
  • Post submission, representing the manufacturer by being in-country representative and interact with HSA throughout and after the registration process 
  • Identification of prospects to leverage authorization and documentation for other markets to efficiently register in Singapore
  • Advice on optimal grouping strategy to minimize registrations and associated costs

Regulatory Strategy and Consulting

Athreva helps you evaluate the Singaporean medical device regulatory framework as it applies to your devices. Athreva’s global regulatory strategy report service for the Singaporean medical device market covers the following topics: 

  • Regulatory roadmap for Singapore
  • Product assessment
  • In-country representative responsibilities in Singapore 
  • Medical device registration requirements
  • Product grouping
  • Cost and timeframes
  • Labelling and language requirements

Device Labeling & Promotional Material

  • Support for labelling design
  • Gap analysis of existing label to meet local requirements
  • Advice on promotional material design

Legal representation/ Authorized Representation for Medical Devices in Singapore

Singapore's Health Sciences Authority (HSA) requires foreign medical device manufacturers with no presence in the country to hire an in-country regulatory representative to manage their product registrations. It is important to assign a regulatory partner who can manage regulatory registration and manage HA communications with the Singapore market.

Athreva has the experience and resources to help you succeed in Singapore. We understand the importance of individual representation and our experts in Singapore have the regulatory expertise to serve the interests of your Devices. As your Registrant, we can:

  • Submit your registration submission and dossier to the HAS
  • Respond to questions from the HSA on your behalf
  • Cooperate with you to ensure you maintain control of your HSA registration

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