BASIC- 5 DAYS COURSE​
Training on Medical Devices Regulatory Affairs- Basic- 5 days Course
Basic- 5 days Course
Medical Devices Rules 2017 are in force now in the country and the Medical Devices Rules will be applicable to all the Medical Devices. All the Manufacturers as well as Importers of Medical Devices Rules 2017 will be required to get their Firms and Devices Registered with CDSCO, do Clinical Trails for new innovations, will be required to get Imports and Manufacturing License.
Once you get the Manufacturing and Import License you need to maintain the license and interact with the regulators and auditors.
What is the duration and tentative course contents
The course is of 5 days duration. The course contents are as below:
Course contents are as Below:
– Pre Lunch
What is a Medical Device and How to classify the Medical Devices. What is Class A(Non-sterile and Non-Measuring)
– Post Lunch
Introduction to QMS as in Schedule V of MDR 2017- Pre Lunch
How to write your Quality Manual, Process Manual, Plant Maste Files and Device Master Files. -post lunch
What are the requirements and fees.
Audits and Post market Surveillance requirements.
Hands on Exercises on Drafting of Quality Manual, Plant Manual, Procedure Manual and Post
Audits and Post market Surveillance requirements.
Cost- INR Full package INR 10,000 PER PARTICIPANT with working Lunch and snacks. On site in factory will be available at Rs. 80,000 for the complete course at site. No restrictions on number of candidates.
Who needs to attend
Persons looking after the Regulatory Affairs, QA Manager, Plant Manager and Biomedical Engineers
Online Certificate Course in Drug and Medical Devices Regulatory
Do you need assistance with application and licensing?
With TMSCPL, you will receive expert advice, 24 hour support, practical guidance and complete technical assistance right from the beginning till the very end of your penetration into the Indian market.