When you go for CDSCO medical device dossier submission more often your documents are not accepted as certain important yet minute aspects of the document could have been overlooked while preparing the package. It could be from improper page numbering to documentation error.
Below are some of the key points to remember while preparing your regulatory dossier for Medical Device submission in India. This is ensure seamless document submission. Ensure that you receive the latest updated version of the checklist from your Authorized Indian Agent.
Power of Attorney and Forms
- The name of the manufacturer has to be same as in Free Sale Certificate (FSC), Form 40, Power of Attorney (POA) and Schedule D(I).
- The name of the Indian agent has to be same as in Wholesale Drug License, Form 40, POA and Schedule D(I).
- The Power of Attorney only needs an Apostil if the manufacturer is part of a Hague convention countries viz. USA, Europe, Canada, Australia, Japan etc.
- The apostilled Power of Attorney should have the word “Apostil” in it to differentiate it from notarization.
- The article number and the pack sizes of the medical devices mentioned in Form 40, POA and Schedule D(I) should be the same as in the Free Sales Certificate from the country of origin. Add a listing of the various sizes of the product in the appendix of the forms.
Regulatory and Quality Certificates
- The notarized Regulatory Certificates FSC from country of origin and FSC from GHTF countries namely USA, Canada, Australia and Japan must mention the product(s) for which the application is filed.
- The notarized Quality Certificates (ISO 13485, CE Full Quality Assurance, CE Design and Declaration of Conformity) have to be within 6 months of validity at the time of submission.
- If the ISO 13485 mentions a warehouse site along with a manufacturing site then an application for two sites (USD 1500 each) has to be filed.
- As per the European Medical Device Committee is no CE Design Certificate for Class I and II products
- Each product/medical device has a separate Declaration of Conformity (DOC). The DOC has to mention risk class. The same need to be printed on the manufacturer’s letter head and signed by the authorized person(s).
Plant Master File
Both the hard and soft copies of the Plant Master File (PMF) with appendices have to be submitted. The key information that should be present in a PMF are,
- Layout of premises, Manufacturing activities, Total employees and Organization chart
- Plant registration certificate/ approval certificate issued by NRA
- Brief information on the site relation to other sites etc
- Brief description of major production and quality control laboratories equipment
- Location & layout plan of premises
- Flow chart. Brief details of manufacture process, quality control system
- System of conformity document followed by manufacture
Device Master File
Both the hard and soft copies of the Device Master File (DMF) with appendices have to be submitted. The key information that the DMF should contain are,
- Device Description, Product Specification & flow chart of the manufacturing process of the device
- Comparative chart of the proposed product along with similar product approved in India
- Quality Control Reports in respect of raw materials & finished products, sterilization reports etc.
- Clinical trial data/Published data.
- Biocompatibility Reports, Physiochemical testing reports
- Test specifications & method of testing
- Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 batches
- Risk Management Report and Essential Principle Checklist
- Original label and Draft label,
- Stability data both for Accelerated & Real time.
- Packaging & Instruction For Use.
Labeling and Predicate Device
The reason these two documents have been mentioned separately is to highlight the importance during the time of submission. Predicate Device Comparative Chart – This is a very crucial information. Based on this the committee either decides to the application is a new drug (Form 44) and eligible for clinical trials.
Labeling is a key document which is checked at the time of submission. The labels must contain the below basic details.
- Date of manufacturing
- Manufacturer name and address
- The name and address of the Importer
- Importer license number (a sample such as 1234 or XXXX)
As per the new amendment on 24th September, 2014 there are two additional documents which needs to be submitted,
- Duly notarized PMS Study Report
- Detail of AEs/SAEs/Death/Recall/complaints of the proposed products reported globally along with protocol for investigation of root cause and CAPA taken by the manufacturer