How to Export Medical Devices in India

How to Export Medical Devices in India

An industry that export medical devices in India, esteemed at USD 4.9 billion, is moderately little yet has seen unprecedented development over the last few years. Developing at a CAGR of 17% over the last five years, the segment is relied upon to keep witnessing double-digit development with a CAGR of 15% in the coming decade. The Indian medicinal device market offers an incredible opportunity of its size as well as a result of empowering policies and regulations that the Government has acquainted to give a fillip to the medical device industry.

For instance, the government has upgraded the regulatory framework for the medical device in 2017 and has carried it at standard with international norms by presenting the concept of ‘risk-based’ regulation. The regulatory licenses issued for import, manufacture or sale of medical devices have been made never-ending in nature to eliminate on unnecessary and time-consuming paper-work, in an offer to build simplicity of working together in India.

Inspection of overseas manufacturing site.— On receipt of an application under sub-rule (1) of rule 34, the Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose.

Grant of import licence.— After examination of documents furnished with the application under sub-rule (1) of rule 34 and on the basis of the inspection report, if inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant licence in Form MD-15 or, may reject such application for which reasons shall be recorded in writing, within a period of nine months from the date of application.

The validity of license.— A license granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless, it has been cancelled or surrendered, provided the authorized agent deposits the license retention fee with the Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each licensed medical device after completion of every five years from the date of its issue.

Read More  -  How to Export Medical Devices in India

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

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If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device   

Post Market Surveillance System

Post Market Surveillance System relies on reactive data gathering. Manufacturers collect and report adverse events from a device post-market, often using manual methods. These adverse events are either directly reported to the manufacturer or they could be reported to Regulatory bodies like FDA in the US (MAUDE database), MHRA in the UK, Health Canada in Canada etc. 

Post Market Surveillance System 

The FDA has government authorization to require post-market surveillance for class II and class III medical devices that meet one of four criteria:

Failure of the device would be reasonably likely to have a serious adverse health consequence. The device is intended to be implanted in the human body for over one year. The device is intended to be a life-sustaining of life-supporting device used outside of a user facility.

Post Market Surveillance Plan

A postmarket surveillance plan is a systematic process that is designed for the monitoring of a specific device. Note that each individual device requires its own PMS plan. Though the plans for different devices may have a lot of similarities, you cannot simply reuse a PMS plan from one device to another. Your PMS plan must define which data should be surveilled, how it should be collected, and how you will investigate or determine reportable trends.

Read More  -  Post Market Surveillance System

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

Read More Article - 
1. Orthopedic Implants Manufacturing
2. disposable syringe manufacturers
3. Dental Implants Manufacturing
4.Blood Collection Tubes Manufacturing
5.How to start the Manufacturing of Disposable Syringes

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device