In India import, manufacture, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945.
What are Medical Devices?
Medical Devices is referred to any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent etc and/or any part or accessory which is used or intended for
- the diagnosis, treatment, mitigation, cure, monitoring or prevention of disease, physical or mental condition, or abnormal physical or mental states or symptoms etc.; or
- As notified in Gazette of India
Most commonly used medical devices manufacturing in India are covered in this article:
- Cardiac Stents
- Drug Eluting Stents
- Intra Ocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein Set
- Orthopedic Implants
- Internal Prosthetic Replacements
- Factory Premises (As per WHO:GMP and/or Schedule M-III)
- Competent Technical Staff i.e. Manufacturing Chemist and Analytical Chemist
- Machinery and Lab Equipment
- Office Accessories
- Machine Men and Workers
- Electricity Supply
- Water Supply
- HVAC unit
- Sterilization Unit
- List of medical Devices to be manufactured
- Non Objection Certificate if required
- Company Registration (in case proprietorship you may skip this process)
- Manufacturing License
- Laboratory License
- Goods and Service Tax Number
Documents required for applying for Manufacturing License of Medical Devices:
Application is to be submitted to Licensing Authority appointed by the State Government or Center Government.
Below we are listing detail of documents that will be required for applying for grant of licence in form-28 for Manufacture of Medical Devices in India:
- Covering Letter including details and address of plant, list of documents and duly signed by authorized person.
- Prescribed Forms duly filled and signed by the Proprietor / Managing Partner / Managing Director/authorized person
- Fees challan in original remitting the required amount of fee in the Head of Account or Original Treasury Challan
- Documents related to ownership of firm (Proprietorship/Partnership/Company)
- Blueprint of Approved Manufacturing Premises Plan/Layout .
- Full particulars of competent and regular technical staff for manufacturing and testing of Medical Devices along with the copies of Educational Qualification, Experience Certificate, Appointment Letter, Acceptance Letter, Joining letter etc.
- Site Master File
- List of Medical Devices intend to be manufactured
- List of machinery and equipment
- Electricity Connection Documents
- NOC if required
- Permission from Health Department/Pollution Department etc.
- Certificate in conformity with Factories Act if any
- Any other approvals (e.g. US FDA)
- Any other documents asked by Licensing Authority
In case of New Devices/not yet approved in India, the applicant has to submit a copy of necessary permission/NOC from the Drugs Controller General (I) along with the application.
All certificates submitted should be within the validity period.
Competent Technical Staff:
Medical Devices manufacturing shall be conducted under supervision of whole time technical staff who may be a Graduate in Science with Physics or Chemistry or Microbiology as one of the subjects; or graduate in Pharmacy; or Degree/Diploma holder in Mechanical or Chemical or Plastic Engineering of a University recognized by the Central government for such purposes.
Labeling of Medical Devices:
Medical Devices should be labeled as per requirements prescribed in Drug and Cosmetic Act and Rules along with Indian Standards Specifications laid down from time to time by the Bureau of Indian Standards
Sections for Manufacture of Medical Devices: –
Medical Device can be manufactured only in a Licensed Premises. A Medical Devices manufacturing unit can be divided into following sections/operations:
- Moulding (The molding section should have proper exhaust system if necessary)
- Assembling (include cutting, washing and drying, sealing, packing, labelling, etc.). The assembling area should be air-conditioned provided with HEPA filters
- Raw Materials
- Storage Area
- Washing, drying and sealing area (wherever required
- Testing facilities
Minimum Recommended Area:
- 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