What are Medical Devices?

Medical Devices is referred to any instrument, material, appliance, apparatus, machine, implant or diagnostic reagent etc and/or any chunk or accessory which is intended or used for

• the treatment, diagnosis, cure, mitigation, prevention or monitoring of disease, mental or physical condition, or mental states or abnormal physical or symptoms etc.; or

• As notified in Gazette of India

Most commonly utilized medical devices manufacturing in nation are covered in this blog:

• Cardiac Stents

• Drug Eluting Stents

• Catheters

• Intra Ocular Lenses

• I.V. Cannulae

• Bone Cements

• Heart Valves

• Scalp Vein Set

• Orthopedic Implants

• Internal Prosthetic Replacements

Requirements

• Factory Premises (As per WHO: Schedule M-III and GMP)

• Competent Technical Staff i.e. Analytical Chemist and Manufacturing Chemist 

• Lab and Machinery Equipment

• Office Accessories

• Machine Workers and Men

• Electricity Supplier

• Water Supplier

• HVAC unit

• Sterilization Unit

• List of medical Devices to be manufacturing

• Non Objection Certificate if needed

Licences Required

• Company Registration (in case proprietorship you might skip this procedure)

• Manufacturing License

• Laboratory License

• Service and Goods Tax Number

Documents needed to apply for Manufacturing License of Medical Devices:

Application is to be submitted to Licensing Authority appointed by Center Government or State Government.

Below we list detail of documents that will be needed to apply for grant of licence in form-28 for Manufacture of Medical Devices in globe:

• Covering Letter including address of plant and details, list of documents and duly signing by authorized person.

• Prescribed Forms duly filled and signed by the Managing Partner/ Proprietor / authorized person/ Managing Director

• Fees challan in original remitting the needed amount of fee in the Original Treasury Challan or Head of Account 

• Documents related to ownership of firm (Proprietorship/ Company /Partnership)

• Blueprint of Approved Layout/ Manufacturing Premises Plan.

• Full particulars of regular and competent technical staff for testing and manufacturing of Medical Devices along with the copy of Educational Qualification, Appointment Letter, Experience Certificate, Joining letter, Acceptance Letter etc.

• Affidavits

• Site Master File

• List of Medical Devices intended to be manufactured

• List of equipment and machinery

• Electricity Connection Documents

• NOC if needed

• Permission from Pollution Department and Health Department etc.

• Certificate in conformity with Factory Act if any

• Any other approvals (e.g. US FDA)

• Any other documents asking by Licensing Authority

In case of New Devices/not yet approved in the nation, the applicant has to submit a copy of NOC from the Drugs Controller General (I) along with application /necessary permission.

All certificates submitted must be within validity time.

Competent Technical Staff

Medical Devices manufacturing would be conducted under the supervision of whole time technical staff who might be

• A graduate in Engineering or Pharmacy (in appropriate branch) from the University recognised by 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 apply after his graduation; or

• A graduate in science, from the University recognised by Central Gov. for such purposes, with Physics or Microbiology or Chemistry as one of the topic and has had at least three years practical experience in the testing or manufacturing of devices to which this licence apply after his graduation; or

• A diploma in Engineering or Pharmacy (in appropriate branch) from the Board or Institute recognised by Central Gov. or State Gov., as the case might be, for such purposes and has had at least four years practical experience in the testing or manufacturing of devices to which this licence apply after his diploma; or

• Having the foreign qualification, the content and quality of training of which are comparable with those specify in clause (i), clause (ii) and clause (iii) and is allowed to work as competent technical staff under rule by Central Government

Label of Medical Devices

Medical Devices must be labeled as per requirements prescribing in Cosmetic and Drug Act and Rules along with Indian Standards Specifications laid down from time to time by Bureau of Indian Standards

Sections for Manufacture of the Medical Devices: –

Medical Device could be manufactured only in the Licensed Premises. A Medical Devices manufacturing unit could be literally divided into following operations/sections:

• Moulding (The molding section must have proper exhaust system if required)

• Assembling (include washing, cutting and sealing, drying, labelling, packing, etc.). The assembling area must be air-conditioned providing with HEPA filters

• Raw Materials

• Storage Area

• Washing, sealing, drying area (wherever required

• Test facilities

Minimum Recommended Zone:

• Mould: 30 square meters

• Assemble: 15 square meters

• Additional Zone: 20 square meters if any more than one kind of medical devices is manufactured in same premises

• Raw Material: 10 Square meters

• Storage Area: 10 square meters for every facility i.e. finished and intermediate product

• Washing, Sealing and Drying: 10 Square meters

• Sterilization: 10 Square Meters

• Testing Facilities, Miscellaneous and Records works: As per Requirement