Cost and Time Required for A-Class Medical Device Registration with Singapore HSA

1. Cost of A-Class Medical Device Registration

The cost for registering an A-class medical device with the Health Sciences Authority (HSA) in Singapore can vary based on factors such as the type of device and the applicant's circumstances (e.g., whether you are a local manufacturer or using a local Authorized Representative). However, general fee information is available.

• Registration Fee: For A-class medical devices, the registration fee is typically lower than that for higher-risk classes (B, C, or D). The fee for A-class devices is generally in the range of SGD 500 to SGD 1,000.

• Authorized Representative (AR) Fees: If you are a foreign manufacturer, you may need to appoint a local Authorized Representative in Singapore. The AR will typically charge a service fee, which can vary widely depending on the services they provide. This fee may range from SGD 2,000 to SGD 6,000 or more, depending on the complexity and scope of the services.

• Other Costs:

  • There may be additional costs for preparing the required documentation (e.g., translation costs if needed, consultation fees, or certification costs if the device requires quality management system certification such as ISO 13485).
  • For example, if you need to obtain conformity assessments (e.g., CE marking or ISO certifications), those costs would be separate.

2. Time Required for A-Class Medical Device Registration

The registration timeline for an A-class medical device with HSA is typically faster compared to higher-risk devices. The process involves submitting your application and undergoing HSA's review.

• Application Submission and Review: The process generally takes between 2 to 4 weeks for HSA to review and evaluate the registration for an A-class device. The review timeline can be shorter if all documentation is in order and no further clarifications are needed.

• Issuance of Certificate: Once HSA completes the review and confirms that all regulatory requirements are met, they will issue the Certificate of Registration. This usually takes an additional 1 to 2 weeks from the completion of the review.

• Overall Timeline: From submission to the issuance of the registration certificate, the entire process typically takes between 4 to 6 weeks under normal circumstances.

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