Regulatory Strategy Consulting (Medical Device)

Your key to success is having a robust regulatory strategy aligned with your business strategy. As you identify the key markets you want to expand into, we can work closely with you to craft your regulatory approach and structure your business activities, to meet your targets.

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Our Regulatory Services

Identifying the risk classification of your medical device and applicable regulatory requirements.

Advising on the best route for product registration, together with preparation of required documents for submission.

As product registration timelines vary based on countries and products, please contact us for more information about expected timelines for registration.

Product Registration License Holder

A good regulatory strategy should evolve according to changes in market needs and regulatory landscape.

Asean Countries

Across ASEAN, Stendard can help you achieve marketing authorisation of your devices – development of regulatory strategy (such as determining the risk classification of your device and the route to market), implementation of your QMS, preparation of the Technical Dossier, and submission of the application to regulatory authorities.

Singapore’s Health Sciences Authority (HSA)

Medical devices are regulated by Singapore’s Health Sciences Authority (HSA), via the Health Production Regulations (2010). They are categorised as either General Medical Devices or In-Vitro Medical Devices. You need to determine your device’s risk classification: Class A (lowest risk), Class B, Class C, Class D, or Class D with a registrable drug. If you’re not sure, you can use HSA’s risk classification tool but if you have any doubts, contact us!

To sell your devices in Singapore:

  • Class B, C and D devices require Product Registration, where you need to submit a Technical Dossier (i.e. ASEAN CSDT) to HSA via MEDICS for their review. Upon approval, the product will be listed on the SMDR.

If your device is already marketed in the USA, EU, Australia, Canada, or Japan, you may be eligible for faster product registration routes.

  • Class A are exempt from Product Registration but need to be listed via MEDICS.

If you are a foreign manufacturer of Cloud-based Class A software, we can also act as your Importer.

Also, to import, distribute, or manufacture medical devices in Singapore, you need the necessary Dealer’s license(s). Since compliance or certification to a Quality Management System (QMS) such as ISO 13485 is necessary to apply for a dealer’s license, Stendard can help implement your QMS and bring you through certification if necessary.

IMPORTANT

Registrant : If you’re not based in Singapore, you need a local company to register the device on your behalf.

Dealer’s license : These are licenses that a local company requires to be a Importer, Distributor, or Manufacturer.

MEDICS : HSA’s online portal

SMDR: Singapore Medical Device Register

US, Europe, China and rest of the world

If you are looking to market your medical devices internationally, our QMS preparation services (ISO 13485 and US FDA 21 CFR) would have you prepared for the global market.

Additionally, we can serve as the main point of contact and anchor as you reach out internationally, as we work closely with our affiliated partners based in the US, Europe, China and other parts of the world.

With the most recent development of the Medical Device Regulation (MDR) in Europe, we are able to provide regulatory guidance to ensure smooth transition from the MDD.

The Global Influence of Stendard’s Services

Do you have any questions?

Drop us an inquiry now!