Medical Device Manufacturing

Technically speaking, a medical device is an equipment used to care for and treat patients. Depending on local laws and regulations, anything from menstruation cups to surgical equipment may be categorized as a medical device. A medical device could be:

  • Something used in medical care, illness avoidance, or wellness maintenance.
  • A factor that may have an impact on human anatomy

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, B, C and D as per Part I of the First Schedule in Medical Devices Rules, 2017.

  1. 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.
  2. 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.
  3. 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.
  4. Class D devices like an implantable pacemaker are of high-risk and must be approved before reaching the market.

Manufacturers of medical devices who are ISO 13485 certified have met or exceeded requirements, making them legitimate and secure.