What Is A Medical Device & Classification Based on the Risk Level?
A medical device is any instrument, apparatus, machine, appliance, implant, reagent for in-vitro use, software, material or related article, used for a medical purpose, such as diagnosis, treatment, or prevention of disease or injury. As per the Indian Medical Device Rules (IMDR) 2017, medical devices are classified into four classes based on their intended use and potential associated risk.
Class A
- Surgical & Nitrile Gloves
- Thermometer
- Surgical Masks & Gown
- N95 Mask & PH Meter
- CryoCentrifuge
- Sample Slides
- Slide Scanner
- Scissors & Forceps
- Artificial Hand & Knee
- OT Table & Light
- Tongue Depressors
- Surgical Microscope
Class B
- Hypodermic Needles
- Infusion Sets
- Syringes
- Gauze Swab
- Oxygen Concentrator
- Ice Lined Refrigerator
- Hematolozy Analyzer
- Glucometer Strips
- Spirometer
- Sphygmomanometer
- Fetal Doppler
- Hearing Aid
Class C
- Implants
- Haemodialysis Catheter
- Bone Plates and Screws
- Patient Monitor & ECG
- Infusion & Syringe Pump
- Nebulizer
- CPAP & BPAP
- PaceMaker
- OutPut Monitor
- Defibrillator & Autoclave
- Ventillator
- Anesthesia Workstation
Class D
- Heart Valve
- Bone Plates and Screws
- Implantable Pacemaker Pulse Generator
- Electronic Epidural Space Locator Control Unit
- Spinal Needle Bioimpedance Navigation Unit
- Ventricular Bypass Device
- Carotid Sinus Nerve Stimulator
- Fistula-Repair Biomatrix Implant
- Tympanic Membrane Contact Hearing Aid
What Is Medical Device Manufacturing License?
A Medical Device Manufacturer Registration License is a document issued by the government. It is an approval of medical devices products of any risk classification for manufacturing in India.
The applicant can apply for manufacturer registration through the online portals of the Ministry of Health & Family Welfare (MoHFW). According to the product classes, you have to fill out the form of application. License for class A & B Forms MD-3 and MD-5 are used. In these forms, you have to mention manufacturer information in the MD-3 form and In MD-5 you have to submit all necessary documents.
For the class C & D, you have to fill in the form MD-7 and MD-9 to obtain the license. MD – 7 form is used for the permission for the sale & distribution of medical devices to manufacturers. And MD-9 is formed for the license for the same.
To obtain the Medical Device Manufacturing license for any class of Medical Device, multiple steps are followed as per Regulatory compliance. The application form is filled through online SUGAM portal and all the documents must be submitted along with the application form to start sell and distribution of medical Devices.
Who Issues Medical Device Manufacturer Registration License?
| Central Licensing Authorities (CLA) | State Licensing Authorities (SLA) |
|---|---|
Import of Medical Device & Manufacture Of Class C & D Medical Devices | Manufacture for sale or distribution of Class A and Class B Medical Device. |
Registration of laboratories for carrying out tests or evaluation. Notified body get registered under CDSCO | Sales, Stock, Exhibit or offer for sale or distribution if IVDs of all Classes. |
Clinical performance evaluation and approval of new In-Vitro diagnostic |
What Are the Benefits of Medical Device Manufacturing License?
Ensure Safety Of The Medical Devices
Build Customer Trust
Enhance Brand & Product Reputation
Provide Legal Protections
Ensure Safety Of The Medical Devices
Who can Apply For Medical Device Manufacturing License?
New Manufacturers
Any person who wants to start a manufacturing business of medical Device
Importer & Manufacturer
Any existing importer or Manufacturer who is willing to start medical device business.
Authorized Representative
Any authorised person on the behalf of Manufacturer or importer
Procedure to Apply For Medical Device Manufacturing License
For the manufacturer registration license just follow the below-mentioned process:-
Step 1: Fill & Submit the Application under MD-12 (MD Manufacturer Test License) On the NSWS Portal.
The application must be submitted online under form MD-12 & the grant of license is under Form MD-13 which also called as Test License. On the successful grant of test license, manufacturers of Medical devices are allowed to manufacture a small number of medical devices as samples to ensure the safety & efficacy of the medical device before it is released in the market. For all product classifications i.e. class A, class B, Class C, and class D: application for a test license in MD-12 is mandatory to apply for the final manufacturing license.
Step 2: Upon the Approval Of Test License Apply for the Final Manufacturing License On SUGAM Portal
After the submission and approval of the test license application, we apply for the final manufacturer license on the SUGAM portal. In case a query is raised against any of the above mentioned list of documents it must be answered provided with appropriate documents.
Medical Devices (as per their risk classification)
Application/Grant Form Needed
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Step 3: Inspection of Manufacturing site By Notified Body / CDSCO
After Submission of Mfg. License application Notified body gets allotted in case of MD 5 and In case of MD 09 CDSCO Comes with a subject expert for inspection of your manufacturing site, after 45-60 days normally.
Allow an inspection of the manufacturing site by the respective inspection body:
Medical Devices(as per their risk classification)
Inspection
For Class A & B
Notified Body assigned by the SLA (State Licensing Authority)
Medical Devices(as per their risk classification)
Inspection
For Class A & B
Notified Body assigned by the SLA (State Licensing Authority)
For Class C & D
CDSCO (Central Licensing Authority)
During inspection, the Notified body (in case of MD05) or CDSCO Auditor (in case of MD09) may or may not raise some NC’s (Non-Conformities). Upon satisfaction from the audit Notified Body or CDSCO Auditor submit the audit report to the State Licensing Authority (State FDA) or Central Licensing Authority (CDSCO).
Step 4 – Manufacturing License Application Reviewed by Regulatory Authority
After submission of your inspection report to your respective licensing authority, they will review your application form, legal documents and technical documents. In case of any confusion or doubt Licensing authority will raise a query on your file on Sugam Portal and your need to resolve these queries accordingly.
Step 5: After the review, the respective will grant the Manufacturer Permission also called as Manufacturing License.
Once the application file and documents are validated and reviewed, the manufacturing license gets granted.
Documents Required For Medical Device Manufacturing License
Following are the key documents an applicant must submit to obtain the medical device manufacturing license, in accordance with the CDSCO, Medical Device Rules, 2017:
- Cover Letter
- Application Form mentioning all the details of applicant and medical device
- ISO 13485 Certification (for quality management system)
- Risk Management Plan
- Clinical Evaluation Report
- Labels and IFU (Instructions for Use)
- Usage Instruction and Warnings
- Payment Receipt (TR6 Challan)
- Quality Assurance Certificate
- Device Master File (DMF)
- Plant Master Report (PMR)
