Medical Devices Assembly - An Overview
The global medical device manufacturing industry is experiencing rapid growth, expected to expand by 11.6% (as per Masterson). This growth surge presents an opportunity for professionals in manufacturing, healthcare, and engineering to explore or advance their careers.
Wish to Diversify in Medical Device Industry? Enter manufacturing by the assembly of components is an excellent start. Even if you lack prior experience, medical assembly offers a front-row view of the medical device production process.
So, let’s understand how you can be a medical device manufacturer.
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What Is Medical Devices Assembly?
Medical devices assembly is the procedure of assembling components to create fully functional medical devices. It encompasses tasks such as design, material selection, and the application of diverse assembly techniques. All of these measures are essential to ensure that medical devices are both safe and effective, adhering to stringent regulatory standards.
Medical Device Packaging / Branding in India
In India, the Central Drugs Standard Control Organization (CDSCO) mandates that the final packaging and branding processes of medical devices require a manufacturing license. It helps protect consumers, holds manufacturers accountable, and maintains truthful and accurate branding practices. Compliance is vital for market approval and ensuring product integrity.
Know more about Primary Packaging Regulation
Regulatory Compliance for Assembling Medical Devices
Regulatory Compliance for Assembling Medical Devices
It involves creating a Right Facility Design/Plan, quality management system, maintaining detailed records, performing risk assessments, testing devices, labeling them correctly, and ensuring they are assembled in clean environments as needed. Failure to comply can lead to legal issues and reputational damage.
In India, the components assembly, and packaging are all under CDSCO’s purview. Below certificates and licenses are a must for the commercialization of the products
- Quality Management system implementation as per CDSCO & ISO 13485
- CDSCO Manufacturing License
Explore How Operon Strategist Can Assist Your Medical Device Manufacturing and Regulatory Needs.
For countries outside India, the regulation varies and are specific to the respective regulatory bodies.
However, as the final/finished product manufacturer, one must take necessary approvals before selling the products in the market. We specialize in the setup of assembly units and finished product manufacturing for medical devices. To know more about our services, read Medical Device Project Consulting
