Two Day Training programme -“Meeting Challenges of PPE / Medical Devices Export Market

The Textiles Committee, Ministry of Textiles, Govt of India is organizing a Two Day Training programme titled “Meeting Challenges of PPE / Medical Devices Export Market” for the PPE Manufacturers/Exporters/Medical Device Industry on 7th & 8th of October 2020 through Video Conference.

The Training programme will include

  • (i)   In depth coverage of market regulations for Masks, Respirators and Coveralls in important export destinations like US & EU.
  • (ii)  Board overview of medical devices regulations of Australia, Brazil, Canada, Japan, Kenya, South Africa, South Korea and India & ISO 13485 Medical Device QMS requirements
  • (iii) Model documentation regarding management system and marketing regulation requirements & contours of 510 K and CE marking dossier making.
  • (iv) A dedicated session on actual Testing requirements of PPE.

Please block your slot by paying Registration Fees of Rs. 5000/- (inclusive of 18% GST) by way of bank transfer in favour of “Textiles committee A/c No. 00000034333402348 IFSC SBIN0000290 with email intimation along with payment Reference Number to E-mail ID: trainingcelltc[at]gmail[dot]com

Detailed outline of the Training Programme is as under

Day -1

Day 2

I  Session

VI Session -  CE Marking


Scope & Purpose

Global PPE / Medical Device Market

Technical Documentation

Briefing on PPE /Medical devices

Affixing CE Mark

Briefing on Regulations/Directives/Treaty

VII Session -  Over View of regulations

II Session -  EU regulations

Australia, Brazil, Kenya, South Africa, South Korea, Taiwan

EU - Medical Device Regulation

VIII Session -  Testing

EU - PPE Regulation

Testing requirements


Testing Practical

III Session - ISO 13485 Standards

IX Session -  Risk Assessment and Technical File

Clause No 4,5 & 6

Risk Assessment

Clause No 7 & 8

Technical File

IV Session -  Over View of regulations

X Session -  US Regulations



Japan, Canada


V Session - Testing


Testing requirements


Testing Practical


To book your slot register here

Contact Details for any queries related to this training program is:
Shri. J. D. Barman, Joint Director
E-mail: trainingcelltc[at]gmail[dot]com
Phone: 022-6652 7513/514.
Mobile:  9449041421.

Publish Date: 
Friday, September 25, 2020
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