How to start Medical Device manufacturing Unit?

For starting manufacturing unit of medical devices, manufacturing license will be issued by state drug control office. You have to complete all requirements as specified below and apply for grant of medical devices manufacturing license. 

Read related: What are the medical devices?

Medical Devices covered under this manufacturing licence:

In-Vitro Diagnostics (Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, I.V. Cannulae, Bone Cements, Heart Valves, Scalp Vein Set, Orthopedic Implants, Internal Prosthetic Replacements etc), mechanical contraceptives (condoms, intrauterine devices, tubal rings), surgical dressings, surgical bandages, surgical staplers, surgical sutures and ligatures, blood and blood components collection bags with or without anticoagulants intended for human or animal use

Requirements:
  • Premises (As per WHO:GMP and/or Schedule M-III)
  • Machinery and equipments
  • Technical persons i.e. manufacturing chemist and analytical chemist
  • Raw material supplier
  • Electricity Supply
  • Water Supply
  • HVAC unit
  • Sterilization Unit
  • List of medical Devices to be manufactured
  • No Objection Certificate if required

Licenses:

Minimum Area Required for Medical Devices manufacturing unit:
  • Moulding: 30 square meters
  • Assembling: 15 square meters
  • Additional Area: 20 square meters if any more than one type of medical devices is manufactured in same premises
  • Raw Material: 10 Square meters
  • Storage Area: 10 square meters for each facility i.e. intermediate and finished product
  • Washing, Drying and Sealing: 10 Square meters
  • Sterilization: 10 Square Meters
  • Testing Facilities, Records and Miscellaneous works: As per Need

General Section in medical device manufacturing unit:
  • Raw Material Section
  • Moulding Section
  • Assembling Section
  • Storage Area
  • Washing, Drying and Sealing
  • Testing Laboratory

Qualification of technical persons for medical device manufacturing unit:

For Medical devices, the whole time employee under whose supervision the manufacture or testing is conducted shall be
  • A graduate in Pharmacy or Engineering (in appropriate branch) from a University recognised by the Central Government for such purposes and has had at least eighteen months practical experience in the manufacturing or testing of devices to which this licence applies after his graduation; or
  • A graduate in science, from a University recognised by the Central Government for such purposes, with Physics or Chemistry or Microbiology as one of the subject and has had at least three years practical experience in the manufacturing or testing of devices to which this licence applies after his graduation; or
  • A diploma in Pharmacy or Engineering (in appropriate branch) from a Board or Institute recognised by the Central Government or the State Government, as the case may be, for such purposes and has had at least four years practical experience in the manufacturing or testing of devices to which this licence applies after his diploma; or
  • Having a foreign qualification, the quality and content of training of which are comparable with those specified above and is permitted to work as competent technical staff under this rule by the Central Government.
Hope above information is helpful to you...
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Comments

  1. Hello sir...your video was useful for me for medical device manufacturing.
    I want more information on licences required for manufacturing.
    Regards

    ReplyDelete
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    ReplyDelete
  3. How much it cost to start this busiiness

    ReplyDelete

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