Siddharth Jain is CEO and Chief Medical Device Regulatory Affair
Advisor of Symbiorph Clinical Trialogy. The company started in
year 2015 and based out in Ahmedabad.
He has more than 10 years of rich experience in Medical Device
CE Certification, Clinical Evaluation, Post Market Clinical Follow-
up (PMCF), Risk Management, Post Market Surveillance, Clinical
Trial, Toxicological Analysis, and Usability Engineering.
He has supported many medical device manufacturing companies
of India to accurately strategies their regulatory pathway and helps
in earliest possible market entry in India, Europe and USA.
He is appointed as a mentor and advisor in various medical device focused incubation centers
like Social Alpha, a Tata Trust Company, Manipal University, Kalinga Institute of Industrial
Technology, Atal Incubation Center and IIT-Delhi and many others.
Currently he is providing consulting service supporting for Voluntary Registration of Medical
Device (Importer and Manufacturer), Import License, Manufacturing License as per Indian
Medical Device Rule, 2017, Setting up the Manufacturing Facility, Quality Management
System Certification as per ICMED and ISO 13485:2016 and CE Certification as per the MDR
2017/745 and IVDR 2017/746, USFDA 510k Approval.
  Expertise Area   
 
 MANDATORY REGISTRATION (IMPORTER AND
MANUFACTURER) AT CDSCO
a) Preparing the SUGAM Online Login Credentials
b) Classification of Medical Device
c) Groping of Medical Device like Hand Piece,
Files etc.
d) Submitting the Information to SUGAM
e) Receiving of the Mandatory Registration
Number
         
 CDSCO MANUFACTURING LICENSE
a) Defining the manufacturing site layout
b) Defining the flow of manufacturing i.e., from raw material entry to dispatch
c) Preparing Site Master File
d) Preparing Device Master File
e) Preparing the Label as per Indian Medical
Device Rule
f) Participation in the Manufacturing License Audit
by the Certification Body
g) Hand holding upto receiving of the
manufacturing license

 CDSCO IMPORT LICENSE

a) Preparing the SUGAM Online Login Credentials
b) Classification of Medical Device
c) Preparation of Site and Device Master File
d) Review and Submission the Import License
Documents (MD-14)
 Risk Management Report
 Biocompatibility Report
 Clinical Evaluation Report
 Certificate of Analysis (3 Batch)
 Manufacturing Information 

 ISO 13485:2016 CERTIFICATION

a) Identification of NABCB accredited Certification Body
b) Documentation and Implementation of Quality Manual, SOPs, Formats, Specification
and Test Methods
c) Training of the employees w.r.t different clauses
of ISO 13485:2016
d) Performing Internal Audit
e) Performing Management Review Meeting. 
f) Participation in the Audit by the Certification Body
g) Resolving the Non-Conformities raised by the Certification Body
h) Hand holding upto receiving of the ISO 13485:2016 Certificate
         
 CLASSIFICATION OF MEDICAL DEVICE AS PER RISK BASD
APPROACH
Symbiorph Clinical Trialogy team has the expertise of more than 10 years in medical
device regulatory affairs. We can support the medical device importer and manufacturer
in proper classification of device as per risk-based approach.

Table 1.0 Medical Device Classification as per Indian Medical Device Rule, 2017
Classification Risk Based Approach Examples
Class A Low Risk Plastic Consumables, Toothbrush
Class B Low-Moderate Surgical Forceps, Impression Material
Class C Moderate-High Dental Implant, Biomaterials
Class D High Drug-Device Combination

 CE CERTIFICATION EU MDR 2017/745

a) CE Certification from Notified Body like TUV SUD, SGS, DQS etc.
b) Compliance to General Safety and Performance Requirements
c) Implementation of Unique Device Identifier (UDI) to keep a
track of your devices
d) Strong and in-depth clinical data to prove safety and
performance claims
e) Stricter equivalency measures
f) New classification rules and addition of re-usable surgical devices requiring NB
oversight
g) Reporting of incidents in the EU portal – EUDAMED 

 US FDA 510K SUBMISSION & APPROVAL

a) In-depth review of your overall regulatory strategy and determination of how the
project will align with your business objectives
b) Development of a project plan;
confirmation of the specific deliverables
c) Identification of Predicate Device
d) Preparing 510(k) documentation
e) Submission and Approval
         

Official CDSCO Fees

Manufacturing licence or loan licence to manufacture Class A or Class B medical device for,-
a) one site; and Rs. 5000
b) each distinct medical device. Rs. 500
Manufacturing licence or loan licence to manufacture Class C or Class D medical device for,-
a) one site; and Rs. 50,000
b) each distinct medical device. Rs. 1,000

CDSCO MANUFACTURING LICENSE REQUIREMENTS for Class B Medical Device

Step 1: Mandatory Registration at CDSCO – SUGAM Portal and received the
registration number.
Step 2: ISO 13485:2016 Certificate from NABCB/IAF accredited Certification Body
Step 3: Classify MEDICAL DEVICE as per risk based into Class A, Class B, Class C and
Class D.
Step 4: Prepare the Site Master File
Step 5: Prepare the Device Master File
Step 6: Create SUGAM Login Id
Step 7: Submit the Document to CDSCO SUGAM Portal
Step 8: Appoint CDSCO accredited external Notified Body for Manufacturing License
Audit if the risk Class of device is Class B
If the risk class of device is Class C, then Join Inspection will be carried out by the State
FDA drug Officer, Zonal CDSCO Officer and experts from IIT/BIS
Note:
a. No Manufacturing License Audit for Class A Medical Device. Manufacturing License will
be granted within 120 days after application submission and upon audit of QMS system as per
ISO 13485:2016.
b. No Drug Inspector will come for Manufacturing License Audit for Class B Medical Device.
For Class B – External Notified Body Cost would be Rs. 1.25– 1.75 Lac + GST + Travelling
Step 9: Submission of Report by the external Notified Body to state FDA.
Step 10: State FDA will review the report of Class B Medical Device
Step 11. Grant of Manufacturing License for Class B Medical Device by state FDA.

 
         
CDSCO MANUFACTURING LICENSE REQUIREMENTS for Class C Medical Device
Step 1: Mandatory Registration at CDSCO – SUGAM Portal and received the
registration number.
Step 2: ISO 13485:2016 Certificate from NABCB/IAF accredited Certification Body
Step 3: Classify MEDICAL DEVICE as per risk based into Class A, Class B, Class C and
Class D.
Step 4: Prepare the Site Master File
Step 5: Prepare the Device Master File
Step 6: Create SUGAM Login Id
Step 7: Submit the Document to CDSCO SUGAM Portal
Step 8: Initial Review of the documents by Zonal CDSCO Officer
Step 9: Join Inspection carried out by State FDA Officers, Zonal CDSCO Officers and
experts from BIS or IIT.
Step 9: Submission of Report by the Inspectors
Step 10: Central CDSCO will review the report of Class C Medical Device
Step 11. Grant of Manufacturing License for Class C Medical Device by Central CDSCO

 
         

SYMBIORPH CLINICAL TRIALOGY

Address Office No.: 203, Eternia Complex, Nr. My My Showroom,

C.G Road, Ahmedabad-38004
Contact Name Siddharth Jain
Position CEO and Chief Medical Device Regulatory Advisor
Mobile 9998038576 (What’s app)
E-mail siddharth@symbiorph.in
Website www.symbiorphclinicaltrialogy.com
LinkedIn https://www.linkedin.com/in/siddharth-jain-84170322/
Google Search Siddharth Jain Medical Device