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Registration for Importers

MD-14 Registration for Regulated Medical Device for Importers

 


As per the Gazette Notifications GSR 102 (dated 11 Feb 2020), a list of 37 medical devices specified in the Annexure of Eighth Schedule of MDR 2017 falls under the category of Regulated Medical Devices, which are as follows:

Disposable Hypodermic Syringes

Disposable Hypodermic Needles

Disposable Perfusion Sets

Substances used for in vitro diagnosis including Blood Grouping Sera

Cardiac Stents

Drug-Eluting Stents

Catheters

Intra Ocular Lenses

I.V. Cannulae

Bone Cement

Heart Valves

Scalp Vein Set

Orthopedic Implants

Internal Prosthetic Replacements

Ablation Devices

Ligatures, Sutures, and Staplers

Intra-Uterine Devices (Cu-T)

Condoms

Tubal Rings

Surgical Dressings

Umbilical tapes

Blood/Blood Component Bags

Organ Preservative Solution*

Nebulizer

Blood Pressure Monitoring Device

Glucometer

Digital Thermometer

All implantable medical devices Equipment

CT Scan Equipment

MRI Equipment

Defibrillators

PET Equipment

X-Ray Machine

Dialysis Machine

Bone marrow cell separator

Disinfectants and insecticides specified in the Medical Devices Rules, 2017

Ultrasound equipment

For the above mentioned 37 Regulated Medical Devices, an importer makes:

an application for grant of license or loan license to import for sale or for distribution of medical device in Form-14/16 (as per the individual case)

a fee, as specified in the second schedule of MDR 2017

respective documents

an undertaking to the effect that the requirements of QMS have been complied with.

Document Requirement:

Power of Attorney

Copy of valid wholesale license or manufacturing license

Free Sale Certificate

ISO 13485/ CE Certificate

Plant Master File from the Manufacturer

Device Master File from the Manufacturer

Part 1. Device Master File for Medical Devices

Part 2. Predicate or reference previous generations of the device.

Part 3. Label and IFU

Part 4. Device Design and Fabrication Process with Flow Chart.

Part 5. Essential Principles Checklist

Part 6. Risk analysis and control summary

Part 7. Design verification and verification of medical equipment.

Part 8 .Biocompatibility validation data.

Part 9. Medicinal substances data if the device contains Drug

Part 10. Biological Safety (TSE/BSE)

Part 11. Sterilization Validation data

Part 12. Software verification and validation of software used

Part 13. Animal studies Preclinical data.

Part 14. Stability validation data.

Part 15. Clinical Evidence

Part 16. Post Marketing Surveillance data

Part 17. Batch Release Certificates or Certificate of Analysis of the finished product

Notarized copy of overseas manufacturing site

Constituent description of the domestic manufacturer or authorized agent.




What are the steps involved in Medical Device Registration?
           

Step 1: Classification of Medical Devices: Medical devices shall be classified on the basis of parameters specified in the First Schedule of MDR 2017, in the following classes, namely:—                                                                                                                                             

low risk - Class A;

low moderate risk- Class B;

moderate high risk- Class C;

high risk-Class D.

Step 2: Grouping of the Medical Devices: The applicant may group medical devices having the same or similar intended uses or commonality of technology and submit them in a single Application.

Single: A medical device sold as a specific packaged unit and does not meet the criteria for a family, IVD test kit, system, IVD cluster, or a cluster. It can be sold in several package sizes.

Family: A medical device family is a collection of medical instruments and each medical device is, (i) from the same license holder; (ii) belongs to the same risk classification class; (iii) has a common intended use; (iv) have the same design and manufacturing process; (v) There are variations that are within the scope of permissible variants.

Systems: Medical devices include systems, which are (i) from the same license holder; (ii) intended to be used in combination to fulfill a common intended purpose; (iii) compatible when used as a system; and (iv) sold under the name Sole Proprietorship System.

Group: A medical device conglomerate is a collection of two or more medical devices, supplied in a package by the same license holder, which, (i) are sold under the name Sole Proprietorship Group; and (ii) have a common intended purpose.

Step 3: Selecting Form for Medical Device Registration: To Import for sale or for distribution of Medical devices or In-Vitro Medical devices, an applicant shall submit an application using:

Form MD14: for import of any type of Medical Device.

Form MD16: for Clinical Investigation/ test/ evaluation/ examination/ demonstration or training.

Step 4: Fees for Medical Device Registration: In a life cycle of a particular medical device, the stages are as below:

Testing License: Testing license for each specific medical device to be imported for clinical examination, testing, evaluation, examination, demonstration or training. (government fee $100)

Fresh License:

License to import Class A medical device for,-

(a) one site; and (Govt. Fees $1000)
(b) each distinct medical device. (Govt. Fees $50)

License to import Class B medical device for,-

(a) one site; and (Govt. Fees $2000)
(b) each distinct medical device. (Govt. Fees $1000)

License to import Class A or Class B in-vitro diagnostic medical device for,-

(a) one site; and (Govt. Fees $1000)
(b) each distinct medical device. (Govt. Fees $10)

License to import Class C or Class D medical devices for,-

(a) one site; and (Govt. Fees $3000)
(b) each distinct medical device. (Govt. Fees $1500)

License to import Class C or Class D in-vitro diagnostic medical device for,-

(a) one site; and (Govt. Fees $3000)
(b) each distinct medical device. (Govt. Fees $500)

Inspection of Overseas Manufacturing Site: (Govt. Fees $6000)

Renew License: After every 5 years, the Import license retention fee will be the same as mentioned above.

Step 5: Document Submission: Along with the application and fee (as specified in Steps 3 and 4), an applicant will upload to CDSCO's Medical Equipment Registration online portal, explaining the construction site, medical equipment, and detailed documentation. Quality Management System. For more information regarding the same, kindly click here.

Step 6: Inspection of overseas manufacturing site: On receipt of an application, 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. The applicant shall be liable to pay a fee as specified in respect of expenditure required in connection with the visit to the overseas manufacturing site.

Step 7: Inspection and Grant of License:

Import from Australia, Canada, Japan, European Union Countries, or the United States of America: After examination of the documents submitted and on the basis of the inspection report, if an inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant a license in Form MD-15 or reject such application for reasons of filed in writing within a period of nine months from the date of application. The applicant is granted a license without any clinical examination.

Imported from countries other than those referred: the license in case of Class C and Class D medical devices may be granted after their safety and effectiveness have been established through clinical investigation in India as specified under provisions of Chapter VII of MDR 2017. In the case of Class A or Class B medical devices the license may be established after their safety and performance through published safety and performance data or through a clinical investigation in the country of origin and a free sale certificate from the country of origin can be presented. 

 

ELT Corporate and Medical Device Registration:

ELT is renowned for its services in all areas of scientific licensing from Corporate Legal Metrology, BIS, Drugs and Cosmetics, Medical Devices, Food Safety, and Environmental Protection to New Technology Patents. ELT Corporate has a team of Advocates, Engineers, M.Pharma, Chartered Accountants, and Company Secretaries. With such a unique combination of talent under one roof, it has always been a hassle-free wonderful experience for large corporates.

ELT Corporate is one of the best Medical Device Consultant in India and always try to provide the best experience to its clients.


How we can help you with Medical Device Registration?

We help our customers develop all documentation, whether it's a device master file, a quality manual, or management accountability.

We help our clients to maintain various records which are mandatory as per MDR 2017.

We also provide expert services in developing quality assurance laboratories.

We help our clients to communicate with government portals and ministries to get licenses.

In a nutshell, we provide our clients with a wide range of medical equipment in India.

 

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