Application for Registration of Notified Medical Devices in India

Module 2

Registration for Medical Devices in India

The following documents are required to be submitted in the following manner and order for the registration of the medical devices for import into India: –

1. Covering Letter – The covering letter is an important part of the application and should clearly specify the intent of the application (whether the application for the registration of the manufacturing site is being submitted for the first time, whether the application is for re-registration or is for the endorsement of additional products to an existing Registration Certificate) the list of documents that are being submitted (Index with page numbers) as well as any other important and relevant information may be provided in the covering letter. The covering letter should be duly signed and stamped by the authorized signatory, indicating the name & designation of the authorized signatory along with the name and address of the firm.

2. An Authorization letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm revealing the name & designation of the person authorized to sign (along with the name and address of the firm) legal documents such as Form 40, Power of Attorney etc. on behalf of the firm should be submitted at the time of submission of the application for registration Duly self-attested photocopies of the Authorization letter may be submitted at the time of submission of subsequent applications. 

3. A duly filled Form 40 as per the Performa prescribed in the Drugs & Cosmetics Rules, signed & stamped by the Indian Agent along with name & designation. The name and address of the Indian Agent should be as given in the Drug Sale Licence in Form 20B & 21B or its renewal in Form 21C. Form 40. Annexure I for Performa for Form 40

4. The requisite fee as prescribed in the form of a Treasury Challan. Performa for Treasury Challan (TR 6. The Receipt in original (TR 6) is required to be submitted along with the application for registration. Applicants are advised to make sure that the TR6 Challan clearly indicates the USD equivalence of the amount paid in Indian Rupees. Annexure II for Performa for TR6

5. Power of Attorney – The authorization by a manufacturer to his agent in India shall be documented by a Power of Attorney executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country, and the original of the same shall be furnished along with the application for Registration Certificate. Apostille Power of Attorney from Hague convention member countries is also acceptable.

Annexure III for Performa for Power of Attorney

While submitting the Power of Attorney, the following points should be kept in mind: –

  • It should be co-jointly signed and stamped by the manufacturer as well as the Indian Agent indicating the name & designation of the authorized signatories (along with the name and address of the firm).
  • It should clearly list the names (generic and Model, if any) of all the proposed devices (including Model No.s., if applicable) along with their specific Indication and/or intended use. Further, the names of the proposed devices should correlate with those mentioned in the Form 40 and Free Sale Certificate to be submitted.
  • The names & addresses of the manufacturer as well as the Indian Agent stated in the Power of Attorney should correlate with the Form 40.
  • It should be valid for the period of said Registration Certificate.

6. A duly attested/notarized (in India) and valid copy of Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B or its renewal in Form 21C issued by the State Licensing Authority.

7. Duly notarized/Appostilled/Attested (by Indian Embassy in the country of origin) and valid copy of Free Sale Certificate/Certificate to Foreign Government/ Certificate of Marketability for each device issued by any one of the countries viz. USA, Canada, Japan, Australia and European Union and from the National DrugRegulatory Authority of the country of origin. Free Sale Certificate should state that the proposed device is freely sold in Country of Origin and can be legally exported. It should also specify name and address of legal and actual manufacturing site along with applied product name(s) in generic and Model name, if any.

8. Duly notarized/Appostilled/Attested (by Indian Embassy in the country of origin) and valid copy of ISO 13485 Certificate in respect of the legal and actual manufacturing site (s).

9. Duly notarized/Appostilled/Attested (by Indian Embassy in the country of origin) and valid copy of CE Full Quality Assurance Certificate /CE Production Quality Assurance Certificate/ CE Type Examination Certificate/ CE Product Quality Assurance in respect of the legal and actual manufacturing site (s), depending upon path of conformity assessment.

10. Duly notarized/Appostilled/Attested (by Indian Embassy in the country of origin) and valid copy of CE Design Certificate in respect of the proposed Device (s) in generic and Model name, if applicable. 

11. Duly notarized/Appostilled/Attested (by Indian Embassy in the country of origin) and valid copy of Declaration of Conformity in respect of the proposed Device (s), if any.

12. Copy of latest Inspection/Audit Report carried out by Notified bodies/National Regulatory Authority/Competent Authority.

13. A) A duly filled Schedule D (I) along with the undertaking as per the Performa prescribed in the Drugs & Cosmetics Act & Rules, signed & stamped by the manufacturer indicating the name and designation of the authorized signatory is required to be submitted Performa for Schedule D (I) is enclosed at Annexure IV.

B) The requirements for Plant/ Site Master File are enclosed at Annexure V.

14. A duly filled Schedule D (II)/Device Master File as enclosed at Annexure VI.

Note:

  • Soft copy of the Plant/ Site Master File may also be submitted along with the application.
  • All certificates submitted should be within the validity period and should have at least six months valid period at the time of submission of application.
  • All the regulatory and legal documents (S. No: 1-12 as given above ) may be provided in one file and other documents like Plant/ Site Master File and Device Master File may be provided as separate file(s).
  • In case of re-registration, a copy of registration certificate in form-41 should be submitted along with application.

Annexures

Central Drug Standard Control Organization

Directorate General of Health Services

Office of Drugs Controller General (India)

(Medical Device Division)

A.1 Checklist for Pre Screening of Applications for Grant of Registration Certificate/Re-Registration Certificate in Form-41 for Medical Devices

Name of the firm: _____________________________________ Date: _______________

TR-6 Challan No:________________Date:_______________Ref: No:_________________

S. No.Administrative/Legal /Technical Documents.Status  
Please Tick(√ )Pg. No.Annexure
1.Covering Letter-Purpose should be clearly mentioned with page number and Index.
2.Authorization Letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm revealing the name and designation of the person authorised to sign (along with the name and address of the firm) legal documents such as Form 40, POA etc.)
3.Application in Form-40
3.1• Duly signed & stamped by the Applicant
3.2• Name of the Medical Device(s) to be registered along with Brand Name, Generic Name, Intended Use, Shelf Life etc.
3.3• Name &Full Address of Authorized Agent in India
3.4• Names & Full Address of Manufacturer & its Factory Premises
4.TR6 Challan
4.1• Fees paid
Total USD………….Equivalent to………………INR
( _________ for site &_________for product)
4.2• Head to Fees Deposited (“0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines)
4.3• Should indicate the name and address of the premises to be registered
4.4• Realisation Stamp
5.Power of Attorney(Original)
12Notarized Device Master file from country of origin including the following information:
• 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.
5.2• Name & Full Address of the manufacturer & its manufacturing site (in line of clause 3.4)
5.3• Name and full address of the Indian Agent
5.4• Name of the Proposed Products(in line of clause 3.2)
5.5• Duly signed, dated with name & designation of the signatory by both Indian agent & the manufacturer
6.Duly notarized Copy of valid Wholesale Licence or Manufacturing Licence of the Indian Agent
7.Dully filled Schedule DI &Undertaking duly signed, stamped & dated with name & designation of the manufacturer.
8.Dully filled Schedule DII &Undertaking signed, stamped & dated with name & designation of the manufacturer.
9.Regulatory Certificates :
9.1Regulatory Certificates :
Duly Apostilled/notarized and authenticated by Indian Embassy in the country of origin and) copy of Free Sale Certificate from National Regulatory Authority of country of origin specifying name and address of legal and actual manufacturing site along with applied product name in generic name and model name (if any)
9.2Duly Apostilled/notarized and authenticated by Indian Embassy in the country of origin and) copy of Free Sale Certificate from National Regulatory Authority of any one of the following countries viz USA, EU, Canada, Japan, Australia
10.Quality Certificates :
10.1Duly Apostilled/notarized and authenticated by Indian Embassy in the country of origin) & Valid Copies of Quality Certificate in respect of the legal and actual manufacturing site (s).
(a) Quality Management System Certificate (ISO 13485)
(b) Full Quality Assurance Certificate /CE Production Quality Assurance Certificate/ CE Type Examination Certificate/ CE Product Quality Assurance
(c) CE Design Certificate (if applicable)
(d) Declaration of Conformity
11.Notarized Plant Master file from country of origin including the following information:
• Layout of premises, Manufacturing activities, Total employees and Organisation 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
12.Notarized Device Master file from country of origin including the following information:
• 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.
13.Duly notarized undertaking from the manufacturer for no change in Device Master File and Plant Master File (For Re registration only) along with Soft copy of PMF and DMF
14.Undertaking for Sale details of the proposed products during last three years in India (For Re registration only )
15.Notarized Undertaking regarding complaints received w.r.t “Not of Standard Quality” of the proposed products during last three years (For Re registration only)
16.Duly notarized PMS Study Report
16.1Detail 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 (if any)
16.2Detail of AEs/SAEs/Death/Recall/complaints of the proposed products during the last three years in India along with protocol for investigation of root cause and CAPA taken by the manufacturer (if any) (For Re registration only)

Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant

Mobile No. :……..………………………….

E-mail:………………………………………

A.5 Checklist for Pre Screening of Applications for renewal of Registration Certificate in Form-41 for Medical Devices

Name of the firm: _____________________________________ Date: _______________

TR-6 Challan No:________________Date:_______________Ref: No:_________________

S. No.Administrative/Legal /Technical Documents. Status 
Please Tick(√ )Pg. No.Annexure
1.Covering Letter-Purpose should be clearly mentioned with page number and Index.
2.Authorization Letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm revealing the name and designation of the person authorised to sign (along with the name and address of the firm) legal documents such as Form 40, POA etc.)
3.Application in Form-40
3.1• Duly signed & stamped by the Applicant
3.2• Name of the Medical Device(s) to be registered along with Brand Name, Generic Name, Intended Use, Shelf Life etc.
3.3• Name &Full Address of Authorized Agent in India
3.4• Names & Full Address of Manufacturer & its Factory Premises
4TR6 Challan
4.1• Fees paid
Total USD………….Equivalent to………………INR
( _________ for site &_________for product)
4.2• Head to Fees Deposited (“0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines)
4.3• Should indicate the name and address of the premises to be registered
4.4• Realisation Stamp
5.Power of Attorney(Original)
5.1• Authenticated either in India before a First class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country (original copy) or Apostilled Power of Attorney from Hague convention member countries
5.2• Name & Full Address of the manufacturer & its manufacturing site (in line of clause 3.4)
5.3• Name and full address of the Indian Agent
5.4• Name of the Proposed Products(in line of clause 3.2)
5.5• Duly signed, dated with name & designation of the signatory by both Indian agent & the manufacturer
6.Duly notarized Copy of valid Wholesale Licence or Manufacturing Licence of the Indian Agent
7.Dully filled Schedule DI & Undertaking duly signed, stamped & dated with name & designation of the manufacturer.
8.Dully filled Schedule DII & Undertaking signed, stamped & dated with name & designation of the manufacturer.
9.Regulatory Certificates :
9.1Duly Apostilled/notarized and authenticated by Indian Embassy in the country of origin and) copy of Free Sale Certificate from National Regulatory Authority of country of origin specifying name and address of legal and actual manufacturing site along with applied product name in generic name and model name (if any)
9.2Duly Apostilled/notarized and authenticated by Indian Embassy in the country of origin and) copy of Free Sale Certificate from National Regulatory Authority of any one of the following countries viz USA, EU, Canada, Japan, Australia
10.Quality Certificates :
10.1Duly Apostilled/notarized and authenticated by Indian Embassy in the country of origin) & Valid Copies of Quality Certificate in respect of the legal and actual manufacturing site (s).
(a) Quality Management System Certificate (ISO 13485)
(b) Full Quality Assurance Certificate /CE Production Quality Assurance Certificate/ CE Type Examination Certificate/ CE Product Quality Assurance
(c) CE Design Certificate (if applicable)
(d) Declaration of Conformity
11.Duly notarized undertaking from the manufacturer for no change in Device Master File and Plant Master File alongwith Soft copy of Device Master File and Plant Master File
12.Undertaking for Sale details of the proposed products during last three years in India.
13.Notarized Undertaking regarding complaints received w.r.t “Not of Standard Quality” of the proposed products during last three years
14.Duly notarized PMS Study Report
14.1Detail 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 (if any)
14.2Detail of AEs/SAEs/Death/Recall/complaints of the proposed products during the last three years in India along with protocol for investigation of root cause and CAPA taken by the manufacturer (if any)

Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant

Mobile No. :……..………………………….

E-mail:………………………………………

Office Use Only:
————————————————————————————————

Accepted for review/Not accepted due to incomplete information in respect of point no. (s) ………………………………………….mentioned above.

Signature: …………………………..

Name of the Reviewer:….……………………….

Date:…………….…………….

Web Link for Download:

Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Medical Devices in India (01.01.2013)
http://www.cdsco.nic.in/writereaddata/Final%20Guidance_Doc_RC_31-10-2012.pdf

Pre- Screening Checklist for – Medical Devices and Diagnostics Division Checklist

Feel free to contact us for any query or clarification

Regards
Dr. Manoj Karwa
Head- Clinical Operations
Auriga Research Ltd

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