FREQUENTLY ASKED QUESTIONS
Fast and Reliable Medical Device Regulatory
FAQ'S - MEDICAL DEVICE
Frequently asked questions are for our valued customers to keep them abreast of the latest developments in the regulatory process and to help them make informed submissions and applications.
Our FAQ’s are a set of dynamic questions and we continue to update them on regular basis to keep them afresh and highly relevant to our valued customers.
1. What is a medical device?
Answer. Notified devices as per Drugs & Cosmetics Act intended for use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government, Government of India, by notification in the Official Gazette, after consultation with the Board.
2. Where can we get a copy of the Drugs & Cosmetic Act 1940 & Rules 1945?
Answer. The copy of the Drugs & Cosmetic Act 1940 & Rules 1945 can be downloaded y a customer from the following link: http://cdsco.nic.in/Drugs&CosmeticAct.pdf
3. Regulatory Authority which regulates the medical devices in India?
Answer. Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
4. Who can be an importer of a medical device into India?
Answer. A company having wholesale license in 20B and 21B and/or manufacturing license Form 28 issued under Drugs and Cosmetics Act, 1940 and Rules 1945 can be an applicant for Registration and import of medical devices into India.
5. Registration and import license requirements for import of IVD’s in India?
Answer. Registration is not required for import of non-notified IVD’s in India. However, the following IVD’s devices are regulated as Drugs under Drugs and Cosmetics Act and Rules, hence registration and import license is required for import in to India. These devices are: Blood Grouping Sera, Testing Kits for HIV treatments, HBsAg and HCV.
6. What are the requirements for import of medical devices in India?
Answer. For import of following medical devices, the manufacturing site and (medical devices) are required to be registered with CDSCO.
i. Disposable Hypodermic Syringes
ii. Disposable Hypodermic Needles
iii. Disposable Perfusion Sets
iv. Cardiac Stents
v. Drug Eluting Stents
vii.Intra Ocular Lenses
viii. I.V. Cannulae
ix. Bone Cements
x. Heart Valves
xi. Scalp Vein Set
xii. Orthopedic Implants
xiii. Internal Prosthetic Replacements
xiv. Ligatures, Sutures, Staples
xv. Intra Uterine Devices (Cu-T)
xvii. Tubal Rings
xviiii. Surgical Dressing
xix. Umbilical Tapes
xx. Blood / Blood Component Bags
These devices covered under Drugs & Cosmetics Act 1940 & Rules 1945 need to submit the application in Form 40 with Schedule D (I), D(II), Power of Attorney forms, Plant Master File, Device Master File, Regulatory Certificates and Free Sale Certificate from either USA, Canada, Japan, Australia or EU along with the prescribed fee.
7. Whether Device manufacturing site required to be inspected before grant of Registration Certificate in Form 41? If yes, how much fees for the inspection or visit of the manufacturing premises of Medical Devices?
Answer. No, however it is mentioned in the D & C Act that a site can be inspected during the registration or after the issuance of registration. The inspection fee prescribed in the D & C Act is USD 5000, while as per GSR 78 (E) it will be increased to USD 6000 w.e.f., 1st Jan 2018.
8. What is the time period for Grant of Registration Certificate?
Answer. In case the application is complete in all respects the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41.
9. What is the Duration/Validity of "Registration certificate" in Form-41 for Medical Devices in India?
Answer. A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue. And as per GSR 78 (E) the license will be valid for 5 years.
10. When should an application for Re-Registration of devices be submitted?
Answer. Applications for Re-Registration should be submitted minimum Nine months ahead of the expiry of the registration certificate. And as per GSR 78 (E) the fee is only to be deposited as renewal.
11. Can a duplicate copy of "Registration certificate" in Form- 41 for Medical Devices in India be obtained from CDSCO?
Answer. A fee of USD 300 [or its equivalent in Indian rupees] shall be paid to obtain duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.
12. Whether Devices, having valid Import Licence, can be imported from any ports of India?
Answer. The ports as defined in Rule 43A of Drugs & Cosmetics Rules only permitted for imports.
13. Whether devices imported under valid import Licence can be stocked in any other wholesale licence premises other than stated in the Import Licence?
14. What is the Test license in Form 11?
Answer. The Test Licence in Form 11 is to import small quantities of drugs / Medical Devices/Diagnostic kits, for the purpose of examination, test or analysis provided that Imported Medical Devices under Form 11 shall not be used for any commercial purposes.
15. What is the validity of "Test License" in Form-11?
Answer. A Test License unless, it is sooner suspended or cancelled, shall be valid for a period of three year from the date of its issue.
16. Whether Registration Certificate and Import Licence are required to import Components of Medical Devices?
Answer. Yes, Devices in assembled form ready for packaging and sterilization are regulated under the provision of Drugs and Cosmetic Act 1940 and Rules there under. Hence Registration Certificate and Import Licence are required to import into India.
17. Whether both legal (If any) and actual manufactures name and address should be stated in the Free Sale Certificate issued by the national Regulatory agency for the purpose of registration of devices in India?
18. Any changes in name and/or address of Indian agent/ Importer or change in constitution after issue of Registration Certificate/ Import Licence are required to be communicated to the Licensing Authority?
Answer. Yes, Indian agent/ Importer shall inform the licensing authority immediately in writing and shall submit fresh application as per Rules.
19. Any changes in name and/or address of legal and/or actual manufacturer or change in constitution after issue of Registration Certificate/ Import Licence are required to be communicated to the Licensing Authority?
Answer. Yes, the manufacturer or his authorized agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and / or address of the registered office / factory premises operating under this Registration Certificate. Where any such change in the constitution of the firm and/or address takes place, the current Registration Certificate shall be deemed to be valid for a maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises.
20. Whether acquisition/merger of one company by another company is considered as change in constitution of the company?
21. What are the changes which do not require fresh registration and only notification or amendment may be obtained?
Answer. Change in shelf life, change in the method of testing, minor change in manufacturing process not affecting the final product specifications, updation in IFU like warnings, precautions, additional instructions and safety etc., labels and packaging (provided proper justification should be provided for the above changes).
22. If there is a change in the Indications and/ or Intended use of a registered notified medical device, does the applicant need to submit a fresh application including Power of Attorney incorporating the changed Indications and/ or Intended use of the registered notified medical device?
Answer. Yes, revised Power of Attorney Schedule D (I), D (II), IFU etc is required to be submitted, reflecting the changes/modification to indications.
23. What is the procedure for adding/ modifying/altering the currently registered Indications for the Medical Devices?
Answer. The process is to file a change notification to CDSCO and this is followed by approval from CDSCO. Revised Power of Attorney, Schedule D (I), D (II) and IFU etc with updated indication will be required to be submitted to CDSCO.
24. Whether any minor change which is notified to the Regulatory Authority but CDSCO’s response is awaited can be imported in India?
25. What is the time line for response to a change notification?
Answer. 90 working days
26. What are the Labelling rules for Medical Devices?
Answer. The Labelling of Medical Devices are to be done as per Rule 109 (A) of Drug & Cosmetics Rules. They also need to follow Rule 6 of Chapter II of Legal Metrology (Packaged Commodities) Rules 2011. The MRP is to be mentioned on each sealable pack as per NPPA order no. F No. 20 (8)/2013/Div-III/NPPA/Part-I.
27. What are mandatory addresses on the labels of registered notified medical devices being imported/ marketed in India?
Answer. The label of registered notified medical devices being imported must include the names and addresses of the legal manufacturer, actual manufacturer and the name and address of importer on which the Import License in Form 10 has been issued.
28. Can the importers of registered notified medical devices incorporate India-specific requirement on labels after/post landing in India at customs warehouse or place approved by the Licensing Authority?
Answer. Yes, importers of registered notified medical devices are currently allowed to incorporate India-specific requirements like name and address of importer, import Licence Number on imported medical devices post landing in India at customs warehouse or place approved by the CDSCO prior to release into market.
29. The Certificate of Exportability (which reflects that the proposed products may not be freely sold in the country of origin but can be exported), is acceptable as Free Sale Certificate?
30. Which manufacturing site is considered the manufacturing premise for the purpose of inclusion in the Form - 40?
Answer. The actual site of final batch release of the medical device is considered the manufacturing premise for the purpose of inclusion in the Form -40.
31. If applicant wants to apply for Registration Certificate but the product is not sold in the country of origin but is registered and marketed in any one of the following countries i.e. USA, Europe, Japan, Canada or Australia. Can he apply for Registration Certificate?
32. What is the generic name of the medical device?
Answer. The generic name is the name as per the internationally accepted nomenclature for the medical devices.
33. What is a “new” medical device?
Answer. A new medical device is one which does not have a predicate medical device registered / approved in India.
34. What is a “predicate” medical device?
Answer. A predicate medical device is one which is registered / approved in India and has the same indications/ intended use, material of construction and design characteristics as the device which is proposed for registration in India.
35. Who will issue Form-9 the manufacturer or the Principle Indian Agent? Ans.Form-9 can be issued by either the manufacturer OR the Principle Indian Agent.
36. How should the documents be notarized?
Answer. The notary should ensure that documents are properly authenticated by signing each document/page or by providing notarization page (Declaration from notary) having name/number of certificate/documents along with pages eg. This part includes certificate X (pages), Certificate Y (pages) etc. and should be intact (Authorized by notary tamper proof) and stapling or pasting not accepted.
37. What is the time limit for submission of Query Response?
Answer. 45 days from the date of issuance of a query or an extension can be sought with justification for delay.
38. Whether shelf life of the device can be stated on the label instead of date of manufacture?
39. If my medical device has an adverse event, do I need to report it to CDSCO?
Answer. Yes, this needs to be reported to the CDSCO.
40. If a recall or corrective action is required for my medical device, do I need to report it to the CDSCO?
41. Can an importer import a registered notified medical device having residual shelf life less than 60 % for Commercial or testing purpose?
Answer. No, as per the Rule (31) the residual shelf life at the time of import should be >60%.
FAQ'S - COSMETICS IMPORT REGISTRATION
Q1. How Cosmetic is defined in India as per Drugs & Cosmetics Act?
Answer. As per Section 3(aaa) of the Drugs and Cosmetics Act 1940 and Rules 1945, cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetics.
Q2. Is cosmetics regulated in India?
Answer. Manufacturing & Imports of cosmetic products are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. The imports of cosmetics were not notified by Gazette notification G.S.R 426(E).
Q3. What are the requirements for import of Cosmetics in India as per GSR 426 (E)?
Answer. For the import of Cosmetics in India, the imported cosmetic products are required to be registered with Central Drugs Standards Control Organization by giving application in Form 42 and Schedule D (III), Power of Attorney and a fee of USD 250 per category of cosmetics as per the DCGI guidelines to obtain Registration certificate in Form 43.
Q4. Who can be an importer of Cosmetics into India?
Answer. Manufacturer, An Authorized Agent of the Manufacturer/Subsidiary of the Manufacturer/any other importer having IEC issued by DGFT can be an applicant for issuance of Registration certificate for import of cosmetics into India.
Q5. What is the time period for Grant of Registration Certificate in Form 43?
Answer. As per Rule 129C provided that if the application is complete in all respects and the information specified in Schedule (D III) is in order, the licensing authority shall, within six months from the date of receipt of an application, issue such Registration certificate.
Q6. What is the Validity of a "Registration certificate" in Form-43 for Cosmetics in India? Answer: A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.
Q7. How to register additional product(s) in the already granted/valid Registration Certificate in Form 43?
Answer. Importer has to apply for endorsement to the existing Registration Certificate along with the requisite documents except fees if the category is already registered and provided that the additional products being manufactured at the same manufacturing site. If additional category needs to be added fees of 250USD per category needs to be paid. Validity of the endorsement issued for these additional products will be same as of main registration certificate.
Q8. How much fees for issuance of duplicate copy of "Registration certificate" in Form- 43Cosmetics in India?
Answer. A fee of one hundred US dollars or its equivalent shall be paid to obtain a duplicate copy of the Registration Certificate.
Q9. Who can issue free sale certificate for Imported Cosmetic products?
Answer. Free sale certificate can be issued by the National Regulatory Authority of Country of origin. In case if it is not issued by National Regulatory Authority from the country of origin then from other competent Associations/ organizations duly authenticated from the Indian embassy of country of origin need to be submitted.
Q10.What information is required on the free sale certificate for the imported Cosmetic products?
Answer. Information required includes the Name and Address of the legal and actual manufacturer with cosmetic products defining all of their variants.
Q11. What are the major changes on granted Registration certificate that require an applicant to make a fresh Registration?
Answer. The following changes which require a fresh registration are as follows –Any change with respect to manufacturer (legal/ actual) like change in constitution, change in name, change in address, including merger and acquisitions etc. Any change with respect to importer/ Indian Agent like change in constitution change in name also needs to be notified to CDSCO and fresh RC to be obtained within 90 days.
Q12. What are the minor changes which do not require fresh registration and only notification or amendment may be obtained? Answer. Change in composition, change in the method of testing, minor change in manufacturing process not affecting the final product specifications, updating in labels and packaging (provided proper justification should be provided for the above changes).
Q13. What is the time limit for submission of Query Response?
Answer. As per DCGI guidelines the response need to be submitted within 45 days.
Q14. Who issues No objection certificate for import of Cosmetic products for R&D purposes like packaging trials, consumer studies, shelf life studies and transport studies?
Answer. ADC’s at the Port offices of CDSCO can issue the above mentioned No Objection Certificates.
- MEDICA13-16 Nov 2017, Germany
- IOACON 26-31 Dec 2017, Indore (India)
- NSICON 30-Nov-3rd Dec 2017, Nagpur (India)
- Arab Health 29th Jan-1st Feb 2018, Dubai