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FDA Certification

FDA Certification

The FDA, or Food and Drug Administration,  doesn't actually issue certifications in the traditional sense.  Instead, the FDA regulates a wide variety of products that affect public health,  including food, drugs, medical devices, cosmetics, and electronic products that emit radiation.  Manufacturers are responsible for ensuring their products meet the FDA's safety and effectiveness standards through a process called premarket approval.

There are different regulatory pathways for different types of FDA-regulated products, but they all involve submitting a detailed application to the FDA that includes data from scientific studies demonstrating the product's safety and effectiveness.  If the FDA approves the application, the manufacturer can then sell the product in the United States.

Here are some of the different types of FDA approvals:

  • Food Additive Petition (FAP): Manufacturers must submit an FAP to the FDA if they want to use a new food additive in a food product.

  • Color Additive Petition (CAP): Similar to an FAP, but for color additives.

  • New Drug Application (NDA): This is the most stringent type of FDA approval, and it's required for all new drugs.

  • Abbreviated New Drug Application (ANDA): An ANDA can be submitted for a generic drug that is similar to an already-approved brand-name drug.

  • 510(k) premarket notification: This is a less stringent type of premarket approval for certain medical devices.

  • Premarket Notification (PMN): This is required for most new consumer products that emit radiation.

FDA Certification in Singapore, Hong Kong, Malaysia

The FDA is the regulatory body for the United States, so its approval process doesn't directly apply to Singapore, Hong Kong, or Malaysia. Each of these countries has its own regulatory agency for medical devices and other FDA-controlled products. Here's a breakdown:

  • Singapore: Health Sciences Authority (HSA) guide to medical device registration - HSA Singapore

  • Hong Kong: Department of Health (DoH) medical device registration - DoH Hong Kong (This website is in both English and Chinese)

  • Malaysia: Medical Device Authority (MDA) medical device registration - MDA Malaysia

While FDA approval holds weight internationally,  manufacturers will still need to go through the separate approval process for each country they want to sell their product in.  These processes may involve similar data requirements but can have different timelines and fees.

How Bestar can Help

While the FDA itself doesn't certify products for Singapore, Hong Kong, or Malaysia, Bestar can assist with the regulatory approval process in these countries. Here's how Bestar might be able to help:

  • Regulatory Expertise:  Understanding the specific requirements of each country's regulatory agency ( HSA in Singapore, DoH in Hong Kong, and MDA in Malaysia) is crucial for a successful application. Bestar, with its knowledge of these regulations, can help navigate the process and ensure your application meets all the necessary criteria.

  • Application Preparation:  The application process can be complex and involve a significant amount of paperwork. Bestar can assist with compiling the required technical documentation,  including data from clinical trials, and preparing the application in the appropriate format for each agency.

  • Communication and Liaison:  Regulatory agencies may have questions or require additional information during the review process. Bestar can act as a liaison between your company and the agencies,  facilitating communication and ensuring a smooth approval process.

To determine how Bestar can specifically assist with FDA certification for Singapore, Hong Kong, and Malaysia, contact us. We can assess your specific product and the regulatory requirements of each country and provide a more tailored plan.


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