About Us
We are a group of Legal LMPC Certificate, EPR and Medical Device Regulatory Consultants having experienced Biomedical Engineers trained in Technology Management. We manage the EPR Registration as per e-Waste (Management) Rules 2022, Plastic Waste (Management) Rules 2022 and Medical Device Registration and Licensing as per New Medical Device Rules 2017.
introduction
We mange the Medical Device Registration and Licensing as per New Medical Device Rules 2017. We also provide documentations for complying to ISO 13485. We provide training for Post Marketing Surveillance management. We have consulted for more than 30 companies for Import License and for Manufacturing License.
We also provide support as Third Party Inspection Agency for Medical Devices. We are ISO 9001:2015 Certified Company and ISO 17020:2012 Certified Company. We provide training in QMS ISO 13485 Compliance
INDIA MEDICAL DEVICES REGULATORY SERVICES
TMSCPL is the catalyst you need to speed up your Medical Device Import as well as Manufacturing registration process without worrying about obstacles. Our experience, professional relations understanding and wealth of practical familiarity in the field serve to ease your way through the process. 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.
Medical Devices have always been an object of concern and regulation by the Indian Government. With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect. Medical devices have been categorized into A, B, C and D classes and are governed by respective central and state regulatory authorities. Regulatory bodies classify medical devices based upon the associated risk and have defined relatively easy procedures for license applications. Similarly, rules and guidelines have been promulgated by the government for the import of medical devices. Whereby, all one needs is to have an authorized Indian agent to apply for the license.
With the reformative intervention and efforts of the government such as the Medical Devise CDSCO online portal, obtaining medical device licenses is now an expedite procedure. We at TMSCPL provide our clients assistance with application and licensing(Manufacturing and Imports) procedures related to Medical Devices.
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.