Manufacturing of notified medical devices (Under CLAA Scheme) for sale in India, a Manufacturing License in Form-28 is required under Drugs and Cosmetics Rules. The Rule 76 of Drugs and Cosmetics Rules describe the information/data required for grant of manufacturing license. Manufacture for sale of Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion sets and In-vitro Diagnostic Devices are regulated by the concerned State Drug Licensing Authority.

Application for the grant of license for manufacture of Medical Devices in India is made in Form 27 to:-

  1. The concerned State Drugs Licensing Authority
  2. The concerned CDSCO Zonal/Sub-Zonal Office and
  3. The Drugs Controller General of India CDSCO (HQ),

The following documents are required to be submitted for grant of license in form-28 for Manufacture of Medical Devices in India:

READ ALSO: Documents required for Notified Medical Device Registration in India.

  1. Covering Letter The covering letter with the list of documents that are being submitted (Index with page number).
  1. An Authorization letter issued by the Indian Agent firm revealing the name & designation of the person authorized to sign legal documents such as Form-27 on behalf of the firm.
  1. A duly filled Form 27 as per the Performa prescribed in the Drugs & Cosmetics Rules, signed & stamped by the Indian Agent along with name & designation.
  1. The requisite fee The License fees is Rs.6000/- plus an Inspection fees of Rs. 1500/- (Total Rs. 7500/- for 10 items for each category of Device) and additional fees at the rate of Rs.300/- for a each additional item of Device.
  1. Constitution Details Documents relating to constitution of firm viz. partnership-deed, memorandum and article of association etc.
  1. Approved Manufacturing Premises Plan/Layout. A copy of Plan/layout approved by the Drugs Licensing Authority should be submitted as stated in Site Master File at C-I
  1. 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.
  1. Site Master File – This will contain specific and factual information about the production and/or control of manufacturing process carried out at manufacturing premises. Some of the key points to address are
  • Layout of premises, Manufacturing activities, Total employees and Organization chart
  • Plant registration certificate/ approval certificate issued by NRA
  • Brief information on the site relation to other sites etc
  • Brief description of major production and quality control laboratories equipment
  • Location & layout plan of premises
  • Schematic drawings of the ventilation and water systems
  • Flow chart. Brief details of manufacture process, quality control system
  • System of conformity document followed by manufacturer
  1. Specific Environmental Requirements as per Annexure-V
  1. Device Master File – This document should contain information on the device and safety. Below are the key points to address,
  • Device Description, Product Specification & flow chart of the manufacturing process of the device
  • Comparative chart of the proposed product along with similar product approved in India
  • Quality Control Reports in respect of raw materials & finished products, sterilization reports etc.
  • Clinical trial data/Published data.
  • Biocompatibility Reports, Physiochemical testing reports
  • Test specifications & method of testing
  • Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 batches
  • Risk Management Report and Essential Principle Checklist
  • Original label and Draft label,
  • Stability data both for Accelerated & Real time.
  • Packaging & Instruction For Use.
  1. List of Medical Devices along with undertaking in prescribed pro-forma as per Annexure VII.
  2. Details of Standards followed by the company for product evaluation
  3. Promotional literature, package insert, device labels etc
  4. ISO 13485:2003 Certificate (if any)
  5. Full Quality Assurance Certificate (if any)
  6. CE Design Certificate (if any)
  7. Declaration of Conformity (if any)
  8. Any other approvals (e.g. US FDA)

READ ALSO: Important Licenses and Forms to Keep in Mind: CDSCO

Important Note:

  • 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.
  • In case the applicant intend to manufacture both SLA(Syringes, needles and perfusion sets) and CLAA (remaining devices) devices, separate applications should be made and separate licenses should be obtained from the concerned licensing authorities.

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