Water Birth Pools – Classification and Certifications

K.D.Brainin Founder & Director
Blog: 06.12.2013

When exporting our water birth pools we often encounter problems that need to be overcome in relation to regulations that are imposed on imports.

The primary issue that usually needs to be resolved is the classification of our birthing pools.

Are they medical devices or not?

We export under the HS Code 39229000 00 which covers sanitary ware like bath tubs, sinks etc.

We have used this code for decades for international shipments.

The birth pools are essentially large baths – they are manufactured by a specialist bath tub manufacturer.

Hospitals have normal baths and hydrotherapy baths – are these considered medical devices?

Natural birth is not a medical event – the mother is not a patient, she is not ill, she is not being treated – she is having a baby.

Just because the bath is being used in a hospital for labour and birth doesn’t necessarily make it medical equipment.

We went through a stringent examination by the NMPA in China who originally wanted us to apply for NMPA registration which would have been very costly and time consuming.

Instead, we opted to file an application to dispute this.

Based on the information we supplied the NMPA declared that in accordance with their regulations that our water birth pools were not medical devices.

Another issue that can cause problems or delays relates to country specific regulations such as the requirements for Certificates of Origin, Certificates of Conformity, Test Certificates or registration with local health ministries.

If any of the above apply please discuss with us early on in the sales process so we can clear these issues before they cause problems or delays.

Active Birth Pools are CE Compliant and meet or exceed building and hygiene regulations world wide.

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