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Are Menstrual Cups regulated by governments around the world?

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WoMena Summary and Approach

WoMena sometimes gets the question: Are menstrual cups (MCs) ‘regulated’ by governments? This is an important question for Government Departments, donors, NGOs and others when planning MC interventions to ensure safety and efficacy of the products. The question sometimes extends beyond MCs to other menstrual health management (MHM) products – washable and disposable pads, tampons etc.

This FAQ tries to address this question in a preliminary manner, with the main focus being MCs, but with other MHM products also mentioned for comparison. This is a complex area, and we do not claim to know the entire truth – simply that we exercise due diligence in trying to find out.
Around the world, there are no globally agreed regulatory framework for approval of MHM products in general, and MCs specifically. The classification, standards, and procedures vary by country. It complicates matters that, according to one source, there are 199 brands of MCs, marketed in 99 countries. For example, in Europe, MCs are generally categorised as “hygiene products”, and expected to comply with general product safety directives for any given country, but with no requirement for further testing or regulation. In the US, in order for the Food and Drug Administration (FDA) to “clear” MCs for sale, manufacturers may need to submit a “premarket notification”, but do not need to go through a more extensive process called “premarket approval”, requiring clinical trials and testing. In fact, we are not aware of any country which requires ‘approval’, which is a term reserved for high risk products (not MHM products).

In Uganda, there is no specific set of standards for the MC. Instead, every batch of imported MCs is cleared by the Uganda National Bureau of Standards (UNBS) according to general standards. That is, at the moment there is no requirement or justification for MCs to be registered or ‘approved’ by the NDA, The NDA has suggested it can be handled by the UNBS, and UNBS is presently considering its follow up.

WoMena’s approach: WoMena is committed to introducing products which are safe, effective, affordable and acceptable. For example, in 2016, with WoMena’s advocacy, based on Uganda Revenue Authority, MCs now fall under classification 9018.90.00/CPC 478 which means only withholding tax (6%) is payable if the importer is not exempted from that. This applies to other MHM products such as menstrual pads as well, making them more affordable.

WoMena has examined the safety of both MCs and other products in terms of infections and harmful chemicals. WoMena is working with partners internationally to include MCs in their lists of products available, as well as further clarify quality standards. WoMena advocates for improved transparency on what components used in producing MCs, and what tests have been conducted. We would be delighted to contribute to a dialogue with Ugandan authorities, providing information which might be helpful for their decision on classifying MCs as medical devices. This could bring both advantages and disadvantages.

To find out the classification status of MCs in other countries, you can go to the national regulatory body (bureau of standards or medicines regulatory authority – National Medicines Regulatory Authorities (NMRA)). Search for the product or for the ‘consumer product manager’ or ‘regulatory affairs manager’.

References

Chu, M., 2017. “Menstrual cups approved for 1st time in Korea.”koreabiomed.com.
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De Maria, C., Di Pietro, L., Lantada, A.D., Madete, J., Makobore, P.N., Mridha, M., Ravizza, A., Torop, J. and Ahluwalia, A., 2018. Safe innovation: On medical device legislation in Europe and Africa. Health Policy and Technology, 7(2), pp.156-165.

Eun-byel,I. 2017. “Korean retailers allowed to sell menstrual ‘cup’.”www.koreaherald.com.
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Lamph, S., 2012. Regulation of medical devices outside the European Union. Journal of the Royal Society of Medicine, 105(1_suppl), pp.12-21.

Lissel, A., Ottenberg, F., Bracio, B.R., Ravizza, A., De Maria, C., Ahluwalia, A., Di Pietro, L. and Trommler, P., 2016, August. Status and solutions to medical device regulations for improving the healthcare landscape in Africa. In 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) (pp. 4329-4332). IEEE.

Ministry of Health (MoH) & Pharmacy and Poisons Board (PPB) of Kenya, 2017. Guidelines on Submission of Documentation for Registration of Medical Devices. PPB/PER/MDV/GDL/003.
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Ministry of Medical Services (MoMS) of Kenya, 2011. Guidelines on Submission of Documentation for Registration of Medical Devices. 1st edt. September 2011. Available from: https://www.fdanews.com/ext/resources/files/archives/p/PHARMACY_AND_POISONS_BOARD_MEDICAL_DEVICE_GUIDELINES_LATEST_FINAL.pdf

Parliament Watch, 2017. Government Waives Taxes On Menstrual Cups, Agriculture and Tourism Items. Available from: https://parliamentwatch.ug/government-waives-taxes-on-menstrual-cups-agriculture-and-tourism-items/. [Accessed 12 December 2019]

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The Period CO. n.d. “FDA approved” menstrual cups – What does it really mean?.
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Therapeutic Goods Administration of Australia., 2018. Guidance on the regulation of menstrual cups in Australia. Version 1, 21 November, 2018. Available from: https://www.tga.gov.au/publication/guidance-regulation-menstrual-cups-australia

Uganda National Bureau of Standards (UNBS).,2016. Imports Inspection and Clearance Scheme. www.unbs.go.ug. [Accessed 11 May.2019]. Available from: https://www.unbs.go.ug/content.php?src=imports-inspection-and-clearance-scheme&pg=content

Uganda National Bureau of Standards (UNBS).2018, 9 January, 2019. Directives On Implementation of UNBS Inspection & Clearance of Imports Regulations 2018. [Accessed 20 May.2019].
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United States of America Food and Drug Administration (FDA), 2020a. Medical Device Exemptions 510(k) and GMP Requirements. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=884. [Accessed 10 May 2020]

United States of America Food and Drug Administration (FDA), 2020b. Product Classification-Menstrual Cup. Available from:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=HHE. [Accessed 06 April 2020]

United States of America Food and Drug Administration (FDA),2005. Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)- Guidance for Industry and FDA staff. Document issued on: July 27, 2005. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/menstrual-tampons-and-pads-information-premarket-notification-submissions-510ks-guidance-industry

United States of America Food and Drug Administration., 2019. “Code of Federal Regulations Title 21.” Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.97

Van Eijk, A.M., Zulaika, G., Lenchner, M., Mason, L., Sivakami, M., Nyothach, E., Unger, H., Laserson, K. and Phillips-Howard, P.A., 2019. Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis. The Lancet Public Health.

Vostral, S.L., 2011. Rely and Toxic Shock Syndrome: a technological health crisis. The Yale journal of biology and medicine, 84(4), p.447.

WHO Regional Office for Africa, 2015. Medical devices regulatory systems at country Level-Kenya. June 2015-April 2016. Available from: https://www.who.int/medical_devices/countries/regulations/ken.pdf?ua=1

WHO Regional Office for Africa, 2009. First African Medicines Regulatory Authorities Conference – Final Report. Addis Ababa, Ethiopia, 31 October – 3 November 2005. Available from: https://apps.who.int/medicinedocs/en/m/abstract/Js17809en/

WoMena, 2016. WoMena is working for lower prices on menstrual cups in Uganda. Available from: https://womena.dk/menstrual-cups-in-uganda/

WoMena, 2018. FAQ-Does the use of menstrual cups increase the risk of toxic shock syndrome? Available from: https://womena.dk/womena-faqs-use-menstrual-cups-increase-risk-toxic-shock-syndrome/

WoMena, 2019a. FAQ-Do menstrual products contain harmful substances? Available from: https://womena.dk/do-menstrual-products-contain-harmful-substances/

WoMena, 2019b. FAQ-Is there any connection between menstrual cups and infections?. Available from: https://womena.dk/is-there-any-connection-between-menstrual-cups-and-infections/