Q1. What is a medical device in India?

Ans: Devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in humans or animals, as determined by the Central Government after consultation with the Board by announcement in the Official Gazette.

Q2. Whether medical devices are regulated in India?

Ans: Yes, the Drugs and Cosmetics Act 1940 and Rules 1945 control the import, manufacturing, sale, and distribution of medical equipment in India.

Q3. Where can we get a copy of the Drugs & Cosmetic Act 1940 & Rules 1945?

Ans: The copy of the Drugs & Cosmetic Act 1940 & Rules 1945 is available at the Link: http://cdsco.nic.in/Drugs&CosmeticAct.pdf

Q4. Is it true that all medical devices in India are regulated?

No, however in India, only notified medical devices are regulated. The Drugs and Cosmetics Act has notified the following medical devices.

NAME OF THE DEVICE NOTIFICATION

NUMBER

DATE OF  NOTIFICATION

Disposable Hypodermic Syringes

GSR 365 (E)

March 17, 1989

Disposable Hypodermic Needles

GSR 365 (E)

March 17, 1989

Disposable Perfusion Sets

GSR 365 (E)

March 17, 1989

In-vitro Diagnostic Devices for HIV,

GSR 365 (E)

August 27, 2002

HbsAg and HCV

GSR 365 (E)

October 6, 2005

Cardiac Stents

GSR 601(E)

October 6, 2005

Drug Eluting Stents

S.O. 1468 (E)

October 6, 2005

Catheters

S.O. 1468 (E)

October 6, 2005

Intra Ocular Lenses

S.O. 1468 (E)

October 6, 2005

I.V. Cannulae

S.O. 1468 (E)

October 6, 2005

Bone Cements

S.O. 1468 (E)

October 6, 2005

Heart Valves

S.O. 1468 (E)

October 6, 2005

Scalp Vein Set

S.O. 1468 (E)

October 6, 2005

Orthopaedic Implants

S.O. 1468 (E)

October 6, 2005

Internal Prosthetic Replacements

S.O. 1468 (E)

 

Q5. What is the name of the regulatory body in India that oversees medical device import regulations?

Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, FDA Bhavan, ITO, Kotla Road, New Delhi -110002, Phone: 91-11-23236973, Fax: 91-11-23236973, E-mail: dci@nb.nic.in

Q6. Which division of CDSCO (HQ) is in charge of medical device registration and import in India?

Ans: The Medical Device & Diagnostics Division of the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002, is in charge of medical device registration and import in India.

Q7. What are the requirements for medical device importation in India?

According to the regulations of the Drugs & Cosmetic Act & Rules, a Registration Certificate in Form 41 and an Import License in Form 10 are necessary for the import of medical equipment into India. The manufacturing site and products (medical devices) must be registered with the Indian drug regulatory body in order to import medical devices (i.e. Central Drugs Standards Control Organization).

Q8. Is it necessary to register and obtain an import licence for non-notified medical devices in India?

Ans: Importing non-notified medical devices into India does not require registration. However, because the following devices are classified as "drugs" under the Drugs and Cosmetics Act and Rules, they must be registered and imported into India. Grouping of Blood Serena Intrauterine Devices (Cu-T), Condoms, Tubal Rings, Surgical Dressing, Umbilical Tapes, Blood / Blood Component Bags, Ligatures, Sutures, Staples, Intrauterine Devices (Cu-T), Condoms, Tubal Rings, Surgical Dressing, Umbilical Tapes, Blood / Blood Component Bags.

Q9. Who has the authority to import medical gadgets into India?

An applicant for registration and import of medical devices into India can be any person/firm/enterprise that has a wholesale licence and/or a manufacturing licence issued under the Drugs and Cosmetics Act, 1940 and Rules 1945.

Q10. To whom should the application for Medical Device Registration/Import License in India be addressed?

The Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), FDA Bhawan, ITO, Kotla Road, Delhi-110002 will receive applications for registration/import licences of medical devices. Fax: 91-11-23236973. Phone: 91-11-23236965 /23236975.

Q11. How can I apply for a "Registration certificate" for medical devices in India using Form-41?

Answer: The steps for submitting a registration application are as follows:

STEP 1: Pay the requisite Registration fee in Bank of Baroda, Kasturba Gandhi Marg, New Delhi, using a TR-6 Challan (in triplicate). A registration fee of $1,500 US dollars [or its equivalent in Indian rupees] must be paid with the application in Form 40 for the manufacturing premises intended for the manufacture of medical devices for import into and use in India. For the registration of a single medical device intended for import into and use in India, a charge of one thousand US dollars [or its equivalent in Indian rupees] must be paid along with the application in Form 40, plus an additional charge of one thousand US dollars for each subsequent medical device:

STEP 2: Compile the Registration dossier according to the instructions found at http://cdsco.nic.in/Medical Div/guidance.htm.

STEP 3: Submit an application for product registration to CDSCO (HQ) in New Delhi.

Q12. Is it necessary to check a device manufacturing site before granting a Form 41 Registration Certificate? If so, how much will the inspection or visit to the Medical Devices manufacturing facility cost?

Answer: No, but if an inspection or visit to the production premises is required, the applicant must pay a fee of $5,000 USD [or its equivalent in Indian rupees] to cover the costs of the inspection or visit..

Q13. What is the procedure for paying fees in India?

Ans: The fees must be paid using a Challan at Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001, or any other Bank of Baroda branch or branches, or any other bank, as notified by the Central Government from time to time, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines": Provided, however, that if a manufacturer in the country of origin pays fees directly, the fees must be paid through the Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, using the bank's Electronic Code in the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fee and Fines," and Fines”, and the original receipt of the said transfer shall be treated as an equivalent to the bank Challan, subject to the approval by the Bank of Baroda that they have received the payment.

Q14. Is there a procedure in place to prescreen applications for the issuance of a Registration Certificate/Import License when they are submitted to CDSCO (HQ) in New Delhi?

Answer: Yes, applications will be pre-screened according to the checklist found at http://cdsco.nic.in/Medical div/medical device division.htm.

Q15. How long does it take to get a registration certificate?

Ans: If the application is complete in all respects and the information stated in Schedules D-I and D-II is correct, the licencing authority must issue a Registration Certificate in Form 41 within nine months of receiving the application.

Q16. How long does the "Registration certificate" in Form-41 for Medical Devices in India last?

Ans: A Registration Certificate is valid for three years from the date of issue, unless it is suspended or terminated earlier.

Q17. How can I add more device(s) to a Registration Certificate that is already accepted and valid?

Answer: If the extra device(s) are being manufactured at the same manufacturing site as mentioned in the Registration Certificate for each additional device, the importer must apply for endorsement to the current Registration Certificate together with the required paperwork. A registration fee of 1000 USD is required. Except for Site Registration Fees (1500 USD) and Plant Master File, the procedures for adding additional Devices to a current Registration Certificate are the same as for a new Registration Certificate.

Q18. When should a device re-registration application be submitted?

Re-Registration applications must be submitted at least nine months before the registration certificate expires.

Q19: What are the prerequisites for device re-registration?

Ans. The requirements for re-registration of devices are the same as for new registrations, with the exception of the requirement for a hard copy of the Plant Master File (PMF) and Device Master File (DMF) if the PMF and DMF do not change. However, a soft copy of the PMF and DMF in the form of a compact disc must be provided with the application.

Q20. Can an applicant submit both a Registration Certificate (Form 41) and an Import License (Form 10) application at the same time?

Answer: Yes, if the Indian agent and importer are the same, an applicant can apply for both a Registration Certificate (Form 41) and an Import License (Form 10) at the same time.

Q21. In India, how much does it cost to get a duplicate copy of a "Registration certificate" in Form-41 for medical devices?

Ans: If the original Registration Certificate is disfigured, destroyed, or lost, a cost of $300 US dollars [or its equivalent in Indian rupees] must be paid for a duplicate copy.

Q22. What are the prerequisites for obtaining an Import License for Medical Devices in Form 10?

Answer: The CDSCO web page at http://cdsco.nic.in/Medical div/medical device division.htm contains the prerequisites for granting an import licence in Form 10.

Q23. How long does the "Import License" on Form-10 for Medical Devices in India last?

An import licence is valid for three years unless it is suspended or cancelled before that time (Till Registration Certificate is valid).

Q24: When should I submit an application for an Import License Renewal?

Answer: Import License applications should be submitted along with Re-Registration applications if the importer and Indian Agent are the same or at least three months before the Import License expires.

Q25. Can devices with a valid Import License be imported from any of India's notified ports?

Answer: Yes, indeed.

Q26. Is it necessary to get several Import Licenses for devices that are registered under a single Registration Certificate by the same Indian Agent/ Importer if he wishes to import from several notified ports?

Answer: No, it's not true. In the case of the import of more than one drug or class of drugs manufactured by the same manufacturer, a single licence may be awarded to the importer, allowing the importer to ship the items through any notified port under the Drugs and Cosmetics Act and Rules.

Q27. Can devices imported under a valid import licence be stored in any wholesale licencing location other than the one specified in the Import License?

Yes, it is true.

Q28. How long does it take to get an import licence?

Ans: If the application is full in all aspects and the information is correct, the licencing authority may issue an import licence in Form 10 within three months of receiving the application.

Question 29. Is it possible to import Notified Medical Devices into India solely for demonstration purposes?

Answer: In India, there is no facility for importing demo samples.

Q30. In CT-Form-17, what is the Test licence?

Ans: The CT-Form 17 Test License allows small amounts of pharmaceuticals, medical devices, and diagnostic kits to be imported for the purpose of examination, test, or analysis, provided that imported medical devices under Form 11 are not used for commercial reasons.

Q31. In CT-Form17, what documentation are necessary for the importation of a medical device for examination, testing, and analysis?

Ans: The CDSCO website (http://cdsco.nic.in/Medical div/medical device division.htm) has all of the necessary documentation for importing devices under test licence.

Q32. In CT-Form-17, what is the duration/validity of the "Test License"?

Ans: A Test License is valid for one year from the date of issuance, unless it is suspended or cancelled sooner.

Question 33. Is it necessary to obtain a Registration Certificate and an Import License in order to import components for medical devices?

Answer: Yes, under the provisions of the Drugs and Cosmetics Act 1940 and its Rules, devices in assembled form suitable for packaging and sterilisation are regulated. To import into India, you'll need a Registration Certificate and an Import License.

Q34. Should the Free Sale Certificate given by the national Regulatory agency for the purpose of device registration in India include both the legal (if any) and real manufacturer's name and address?

Answer: Yes, indeed.

Q35. Is it necessary to notify the Licensing Authority of any changes in the name and/or address of the Indian agent/importer, as well as any changes in the constitution, after the issue of the Registration Certificate/Import License?

Answer: Yes, the Indian agent/importer must promptly notify the licencing authority in writing and submit a new application in accordance with the rules. Q34. Should the Free Sale Certificate given by the national Regulatory agency for the purpose of device registration in India include both the legal (if any) and real manufacturer's name and address?

Answer: Yes, indeed.

Q35. Is it necessary to notify the Licensing Authority of any changes in the name and/or address of the Indian agent/importer, as well as any changes in the constitution, after the issue of the Registration Certificate/Import License?

Answer: Yes, the Indian agent/importer must promptly notify the licencing authority in writing and submit a new application in accordance with the rules.

Q36. Is it necessary to notify the Licensing Authority of any changes in the legal and/or actual manufacturer's name, address, or constitution after the granting of the Registration Certificate/Import License?

Answer: Yes, in the case of any change in the composition of the firm and/or address of the registered office / factory premises functioning under this Registration Certificate, the manufacturer or his authorised agent in India must promptly notify the licencing authority in writing. Where a change in the firm's constitution and/or address occurs, the current Registration Certificate will be deemed to be valid for a maximum of three months from the date of the change unless, in the meantime, a new Registration Certificate in the name of the firm with the changed constitution has been obtained from the licencing authority.

Q37. Is the acquisition or merger of one firm by another considered a change in the firm's constitution?

Answer: Yes, indeed.

Q38. What are the changes that necessitate a new registration for an applicant?

Answer: The following modifications necessitate a new registration – Any change in the manufacturer's legal or actual status, such as a change in constitution, a change in name, a change in address, and so on. Any changes to the importer/Indian agent, such as a change in the constitution, a change in the name, etc.

Q39. What are the modifications that do not necessitate a new registration and just require notification or amendment?

Ans. Changes in shelf life, testing methods, minor manufacturing process changes that do not influence final product standards, IFU updates such as warnings, precautions, extra instructions, and safety, labelling and packaging (provided proper justification should be provided for the above changes).

Q40. Does the applicant need to file a new application with Power of Attorney including the changed Indications and/or Intended use of a registered notified medical device if the Indications and/or Intended use of the registered notified medical device change?

Answer: Yes, you must submit an updated Power of Attorney that reflects the changes/modifications to the indications.

Q41. How do you go about increasing or changing the presently recorded indications?

Answer: In this scenario, the procedure for notifying CDSCO of a modification and receiving approval shall be followed. The CDSCO will require a revised Power of Attorney that includes the expanded/modified indication.

Q42. Can any small change that has been notified to the Regulatory Authority but has yet to get a response from the CDSCO be imported into India?

Answer: Certainly not.

Q43. How long does it take to respond to a change notification?

Answer: 90 days to complete.

Q44. Are original labels as per Rule 96 required to be given to the CDSCO when filing applications for registration/re-registration of medical devices?

Answer: While original labels in accordance with Rule 96 are necessary, applicants may provide a coloured copy of the original label that includes all of the elements needed by Rule 96. All models for which registration is requested should be included on the labels.

Q45. What are the mandatory addresses on the labels of imported/marketed registered notified medical devices in India?

Ans. The names and addresses of the legal manufacturer, actual manufacturer, and the name and address of the importer on whom the Import License in Form 10 has been issued must all be included on the label of registered notified medical devices being imported.

Q46. Can importers of registered notified medical devices include India-specific requirements on labels after or after landing in India at a customs warehouse or another location permitted by the Licensing Authority?

Answer: Yes, importers of registered notified medical devices are currently permitted to include India-specific requirements such as the importer's name and address, as well as the import License Number, on imported medical devices after they arrive in India at a customs warehouse or another location approved by the CDSCO prior to their release into the market..

Q47. Can the ISO 13485 Quality Manual be used instead of the Plant Master File?

Answer: Yes, indeed. The content of the provided Quality Manual matches that of the Plant Master File.

Q48. Is it necessary to indicate the number of personnel in the manufacturing facility in the Plant Master File? However, by the time the Plant Master File is compiled and uploaded, this number may have changed?

Answer: Yes, for the purposes of registration, the number of employees as of the date of compilation of the Plant Master File will be taken into account.

Q49. Is a Certificate of Exportability acceptable as a Free Sale Certificate (indicating that the proposed products may not be freely sold in the country of origin but may be exported)?

Answer: No

Q50. For the purposes of the Form – 40, which manufacturing site is considered the manufacturing premise?

Answer: For the purposes of the Form – 40, the manufacturing premise is the location where the medical device's final batch is released.

Q51. If an applicant has requested for a Registration Certificate and it has not yet been provided, but there has been a change in the constitution of either the Manufacturer or the Indian Agent, or the address of the Manufacturer, are new fees for plant registration and product registration required?

Answer: Yes, indeed. The applicant must submit a new application together with the required money.

Q52. If the applicant wishes to file for a Registration Certificate, but the product is not offered in any of the following countries: the United States, Europe, Japan, Canada, or Australia. Is he eligible to apply for a Registration Certificate?

Answer: No, it's not true. However, if the device's safety and efficiency are demonstrated through clinical trials in India, can apply for registration certificate.

Q53. If the applicant wishes to file for a Registration Certificate but the product is not sold in the country of origin but is registered and promoted in one of the following countries: the United States, Europe, Japan, Canada, or Australia. Is he eligible to apply for a Registration Certificate?

Answer: Yes, indeed.

Question 54. What is the medical device's generic name?

Answer: The generic name is the name given to the medical equipment in accordance with internationally approved nomenclature.

Q55. What is the definition of a "new" medical device?

A "new" medical device is one that does not have a predicate medical device that has been registered or approved in India.

56. What is a "predicate" medical device, exactly?

Answer: A "predicate" medical device is one that is registered or approved in India that has the same indications/intentions, construction materials, and design characteristics as the device that is submitted for registration in India.

Q57. What distinguishes the process of registering a "new" medical device from that of registering a medical device for which predicates exist?

Answer: Medical devices that have been notified but have not yet been registered in India are categorised as "new" medical devices. Medical Device Advisory Committees (MDAC) are tasked with providing feedback on proposed New Devices' safety, effectiveness, necessity, and desirability.

Q58. What are the different types of medical device advisory committees?

Answer: Medical Device Advisory Committees currently cover the following specialties: cardiology, dentistry, ophthalmology, orthopaedics, reproductive medicine, and urology, as well as a committee for miscellaneous devices. In addition, the CDSCO has established a "General Expert Pool" for the Medical Device Advisory Committee, which would advise India's Drugs Controller General on subjects relating to the review and regulatory approval of new medical devices and clinical trials.

Q59. Will the manufacturer or the Principle Indian Agent be the one to issue Form-9?

Answer: The manufacturer or the Principle Indian Agent can both issue Form-9.

Q60. What is the best way to notarize the documents?

Answer: The notary should ensure that documents are properly authenticated by signing each document/page or providing a notarization page (Declaration from notary) with the name/number of certificate/documents along with pages e.g. “This part includes certificate X (pages), Certificate Y (pages)” etc., and that they are intact (Authorized by notary tamper proof), with no stapling or pasting allowed.

Q61. Is there a deadline for submitting Query Responses?

According to the provisions of the Drugs and Cosmetics Act and Rules, there is no time restriction for submitting Query Responses; nonetheless, it must be fair and justifiable.

Q62. Can a third-party/authorized consultant inquire about the application's status?

Answer: No, it's not true. If an application is past the time limit set by the Drugs and Cosmetics Act and Rules, only the applicant or his authorised Regular employee may inquire about its status.

Q63. When the CDSCO requests a Technical Presentation on behalf of the applicant, who is permitted to make it?

Ans. Only a company's subject expert or technical person who is equally capable of giving a technical presentation.

Q64. Can an importer who has a valid Form-10 licence but has a minor change in the name or address of the importer continue to import until a new licence is issued?

Answer: No, the product label should comply with the details stated in the Form-10 for the goods at the time of import.

Q65. Can ISO symbols like etc. be used on the labels of registered notified medical equipment imported into India?

Answer: Yes, ISO symbols are permissible on labels of registered and notified medical equipment imported into India.

Q66. Can the device's shelf life be indicated on the label instead of the date of manufacture?

Answer: Yes, indeed.

Question 67. According to the Drugs and Cosmetics Act, 1940, what are the mandatory addresses on the labels of registered notified medical devices being imported/marketed in India?

Answer: Legal Manufacturer's, Actual Manufacturer's, and Importer's names and addresses are listed on Form-10.

Q68. As per the advice paper, all certificates having a minimum validity of six months are required. Is it possible for the applicant to give renewed certificates if the original certificate expires during the review process?

Answer: All certificates with a minimum validity of 6 months must be presented, according to the Registration/Re-registration Guidance document. If the applicant has a good reason for not being able to submit the certificate within the specified time frame, they can give the CDSCO an undertaking that new certificates will be submitted as soon as the old ones expire, and that such cases will be handled on a case-by-case basis according to the rationale for the delay.

Q69. Do I have to notify CDSCO if my medical device has an adverse event?

Answer: Yes, please visit our website athttp://cdsco.nic.in/pharmacovigilance.htm to learn more about the adverse event reporting criteria, protocol, and timing.

Question #70. Do I have to notify the CDSCO if my medical equipment requires a recall or corrective action?

Answer: Yes, indeed.

Question 71. Is it possible to import a medical equipment with a brand name if the Import License (Form-10) shows a product (medical device) with a generic name or vice versa?

No, the answer is no.

Question 72. Is it possible for an importer to bring in a registered notified medical equipment with a residual shelf life of less than 60% for commercial or testing purposes?

Answer: No, it's not true.

Q73. Can a one-time import permit for a regulated medical device be given without a valid Form-10 Import License?

Answer: NO

Q74 is the number. What are the regulatory requirements for veterinary medical device import, manufacture, and labelling?

Answer: The same goes for human-made gadgets.