Understanding the Regulatory Landscape for Menstrual Cup Manufacturing in India
Menstrual Cup is categorized as a medical device in many countries across the globe. The regulatory landscape for medical devices in India is evolving, and there may have been changes or updates since then. It’s important to consult the latest regulatory sources or seek legal advice for the most current information. However, as of latest update in January 2022, the key regulatory compliance requirements for medical devices manufacturing in India include,
Medical Device Rules, 2017
The Medical Devices Rules, introduced in 2017, outline the regulatory framework for medical devices in India. The MDR 2017 classifies medical devices based on risk and regulatory requirements vary accordingly for different medical devices.
Many governments including but not limited to India, Australia, Canada, Japan, European Union Countries, or the United States of America, require the facilities that produce medical equipment to meet certain quality, consistency, and safety standards for the sake of the people who use these products. Internationally different countries have their own classification of medical devices. India has recognized four types of medical devices:
- Class A has the lowest risk of injury and is not designed to sustain human life, such as an acupressure wristband or a face shield. These can be with or without exemptions.
- Class B has low-moderate risk of injury and is not designed to sustain human life such as a menstrual cup or a Fallopian tube catheterization kit. However, these devices require reasonably additional oversight than a Class A medical device. These have to meet certain performance standards depending on their usage.
- Class C products are moderate-high risk, require approval before reaching the market, and have a higher risk of injury from use. An example would be a contraceptive sponge.
- Class D devices like an implantable pacemaker are of high-risk and must be approved before reaching the market.
The CDSCO, under the Ministry of Health and Family Welfare is the primary regulatory authority for medical devices in India. Menstrual Cup, being a Class B medical device, it is mandatory for the manufacturer or importer to submit application for manufacturing the menstrual cup. It is not safer to buy a menstrual cup to buy from a manufacturer with no license from CDSCO.
Medical Device Quality Management System (MD-QMS)
It is mandatory for every manufacturer to register the manufacturing site with CDSCO and apply for the manufacturing license. The MDR 2017 makes it mandatory to be compliant with ISO 13485 Medical Devices Quality Management System (MD-QMS) to establish and maintain a QMS for the design, manufacture and supply of the menstrual cup.
The conformity Assessment Procedures including but not limited to self-declaration, third-party assessment, MD-QMS audit or obtaining a license from CDSCO. Medical devices like condom and menstrual cups require clinical investigation and performance evaluation to establish safety and efficacy of the device across all levels of risk classification.
Post-Market Surveillance (PMS)
As part of the MD-QMS process, every manufacturer is required to establish a PMS system to monitor the performance of their devices rolled out to the market. It is mandatory to report any kind of adverse event due to the medical device in the market.
Import Licenses
CDSCO is the nodal agency to provide import license for any risk-class of medical devices into India. It is also required to prove that the foreign manufacturers are compliant to the Indian regulatory framework.
Please note that this is not an exhaustive list, and the specific requirements can vary based on the type and classification of the medical device. Additionally, regulations may have evolved since my last update, so it’s crucial to check the latest guidelines from regulatory authorities in India. Consulting with regulatory experts or legal professionals familiar with the Indian regulatory landscape for medical devices is highly recommended.
