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Hartford Technologies Blog

Key Regulatory Requirements In Medical Manufacturing

Posted: Feb 22, 2023 10:18:57 AM

Valued at over $175 billion, the medical device industry is large and wide, forever growing as technology continues to advance. When it comes to medical manufacturing, the industry, manufacturers, and suppliers are mandated to follow meticulous quality control standards and compliance in order to adhere to stringent regulatory requirements.

Every medical device must meet applicable standards and guidelines in order to get Food and Drug Administration (FDA) approval before it goes to market. Read on to understand what these standards are like and how they ensure the safety of patients.

Medical Manufacturing Standards

Manufacturers of medical devices must adhere to strict standards to ensure the safety and efficacy of the products they produce. These rigorous regulations are set forth by both:

  • The Food and Drug Administration (FDA)
  • World Health Organization (WHO)

These guidelines serve as a benchmark for quality control. They ensure that all manufactured goods meet safety requirements and provide optimal performance.

Cleanliness Standards

The medical industry has the highest standards for cleanliness and sanitation. This is because many parts of medical machinery and devices come into contact with:

  • Patients
  • Their fluids
  • Medications

Regular inspection of machinery and workspaces helps to maintain sanitation standards. A sterile environment is best for storing parts. Hartford Technologies maintains these standards to make sure that our parts are free of any type of contamination.

Quality Control Standards

A substandard part of a medical device can impact a patient's health. At Hartford Technologies, we inspect often and have fail-safes in place to make sure that our parts do not malfunction. We understand that lives depend on the parts we make, and we take this responsibility very seriously.

Some of the regulatory requirements we strictly follow include:

  • Establishment Registration
  • Investigational Device Exemption (IDE) for clinical studies
  • Quality System (QS) Regulation
  • Medical Device Listing
  • Labeling Requirements
  • Medical Device Reporting (MDR)
  • Premarket Notification 510(k) or Premarket Approval (PMA)

Establishment Registration

Manufacturers and distributors of medical devices must register their establishments with the FDA. Verification of registration happens between October 1st and December 31st each year.

Foreign manufacturers must also choose a U.S. agent. Since October 1, 2007, most establishments must pay an establishment registration fee.

Medical Device Listing

Manufacturers must list their devices with the FDA. The device listing includes basic information about the brand and model of each device, along with its intended use. The FDA uses this information to ensure the safety and efficacy of medical devices.

Establishments required to list their devices include:

  • Manufacturers
  • Contract manufacturers
  • Remanufacturer manufacturers of accessories and components
  • Contract sterilizers
  • Repackagers
  • e-labelers
  • Specification developers
  • Reprocessing single-use devices
  • U.S. manufacturers of "export only" devices

Premarket Notification 510(k)

Before a business can put a device that is similar to an existing medical device on the market for sale, it may require the submission of a Premarket Notification 510(k). This includes a device that is equivalent to one already available, or with the same intended use. The company must first receive a letter of equivalence from the FDA.

A 510(k) allows the FDA to decide that the device is equal to one that is legal for commercial distribution in the United States (before May 28, 1976).

Premarket Approval (PMA)

Products that need a Premarket Approval (PMA) classify as high-risk Class III devices. These devices must be determined to be safe and effective through a lengthier review process.

These items are not equal to the current Class I and II predicates via the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device.

Investigational Device Exemption (IDE)

The FDA grants exemption for medical devices that are still in the testing and development phase. The IDE allows manufacturers to conduct clinical studies on their devices. This helps them to collect safety and effectiveness data.

This data will support:

  • A Premarket Approval (PMA) application
  • A Premarket Notification 510(k) submission to FDA

It protects the rights and welfare of human subjects participating in the study.

Quality System (QS) Regulation

The Quality System (QS) regulation is a set of guidelines and requirements set by the FDA. It applies to all medical device manufacturers. This regulation helps ensure the safety and efficacy of products and services related to medical devices.

These regulations cover processes such as:

  • Design controls
  • Production
  • Process controls
  • Post-market surveillance

It ensures that medical devices are always manufactured to the highest quality standards.. Manufacturing facilities must undergo FDA inspections to assure compliance with the QS requirements.

Labeling Requirements

Labeling requirements for medical devices are set forth by the FDA. These requirements (FDA’s 21 CFR 8010) mandate that adequate information about the device be available when sold. These include:

  • Intended use
  • Warnings
  • Precautions, and contraindications

The labeling must also include information about the device's manufacturer, including:

  • The manufacturer's name
  • Address
  • Contact information

Medical Device Reporting (MDR)

MDR is a way for the FDA to identify and track potential problems with medical device products. It helps manufacturers develop better ways of detecting and preventing product-related problems.

Manufacturers must adhere to FDA regulations by submitting MDRs if they discover a risk of injury or death related to their device.

Export Regulations

Manufacturers must follow export regulations when exporting their medical devices. To do this, they must register with the FDA and get an export registration number.

When exporting medical devices, companies must also obey the regulations of international authorities. These may include obtaining special permits or certifications.

Enhance Your Manufacturing Standards

Medical manufacturing guidelines and regulations are updated often. At Hartford Technologies, we maintain high sanitation standards in the manufacturing of medical devices. We have set strict protocols to maintain a clean environment.

Our parts used for medical devices meet the highest standards of safety and effectiveness for patients. We perform rigorous and stringent testing and monitoring to ensure compliance. You can rest easy when you purchase parts for medical devices from us. Contact us today to learn more.