Medica Device

The owner or operator of a business (facility or facility) involved in the production or distribution of medical devices intended for use in the United States must annually register the business with the U.S. Food and Drug Administration. This process is called the facility registration process.

The US Congress has given the Food and Drug Administration authority to collect annual tuition fees from businesses. The details of who you must register and pay for the facility are described in detail in the document “Subject to Registration and Payment”. The annual registration fee is collected for SMEs and all other businesses in the same amount.

Most of the business registration targets are the device registration targets, and information on what production activities are in charge of the production of products being manufactured on site must also be provided. If the product is subject to premarket approval or premarket declaration in the United States, the owner or operator of the business must complete the relevant procedures (510(k), PMA, PDP, HDE).

• 

  Conformity procedure

  Medical devices are classified according to the risks they pose to patients. Depending on the type of product and grade, the conformity assessment process will be categorized as 510(k) (premarket notification and specific management) and Premarket Approval (PMA) registration.
  
  FDA applies one of three classes based on regulations required to ascertain safety and effectiveness.
  
  Additionally, classification is evaluated based on risk. In other words, the risk to patients and users of medical devices is an important factor in assigning ratings. Class 1 includes devices with the least risk and class 3 includes devices with the highest risk.

• 

  Classification

  1. Class 1 medical device

  • 1 class refers to the class of medical devices that are subject to general management only.
  • Product types : band, surgical gloves, surgical knife, surgical brush

  2. Class 2 medical device

  • 2 grade refers to the class of medical devices that are subject to special management or will eventually be subject to special management.
  • Product types : condoms, contact lenses, infusion pumps, bone powder, tooth material

  3. Class 3 medical device

  • Class 3 refers to the class of medical devices that require or will require Premarket Approval in accordance with Section 515 of the Act.

• 

  Premarket Approval

  Medical devices are classified according to the risks they pose to patients. Depending on the type of product and grade, the conformity assessment process will be categorized as 510(k) (premarket notification and specific management) and Premarket Approval (PMA) registration.
  
  FDA applies one of three classes based on regulations required to ascertain safety and effectiveness.
  
  Additionally, classification is evaluated based on risk. In other words, the risk to patients and users of medical devices is an important factor in assigning ratings. Class 1 includes devices with the least risk and class 3 includes devices with the highest risk.

• 

  How to register medical devices (510k)

  Premarket Notification-510(k) / Applied to 1st and 2nd class medical devices.
  
  Class 1 medical devices are 510k with the exception of some Class 1 medical devices. And Class 2 medical devices must submit a premarket notification to the FDA.
  
  Premarket notification includes facility registration.

  1. Audit period

  • About 90 to 180 days (Sometimes it takes a year of audit.)

  2. Premarket notification contents

  • Fill in the applicant's name, address, manufacturer, sterilization facility address, registration number, and application date.
  • Product description: product name, classification, appearance and structure, purpose of use, principle of operation, labeling and performance criteria
  • Evaluation report, evaluation report on biocompatibility and performance

• 

  Medical device requirements

  • Registration of manufacturer
  • List of all manufactured devices
  • Records maintained and reported by the manufacturer
  • Regulation on labeling
  • Regulations on repair and refund of medical devices
  • Registration of medical devices and facilities