Rules for Registration of Notified Medical Devices and Diagnostic Kits in India

Module 1

Notified Medical Devices and Diagnostic Kits:

Definition of Medical Device: “Devices intended for internal or external 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 by notification in the Official Gazette, after consultation with the Board.”

All medical devices are not regulated in India. However only notified medical devices are regulated in India.

The following medical devices are notified under the Drugs and Cosmetics Act.

  1. Disposable Hypodermic Syringes
  2. Disposable Hypodermic Needles
  3. Disposable Perfusion Sets
  4. In-vitro Diagnostic Devices for HIV, HbsAg and HCV
  5. Cardiac Stents
  6. Drug Eluting Stents
  7. Catheters
  8. Intra Ocular Lenses
  9. I.V. Cannulae
  10. Bone Cements
  11. Heart Valves
  12. Scalp Vein Set
  13. Orthopaedic Implants
  14. Internal Prosthetic Replacements

Manufacture for sale of Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion sets and In-vitro Diagnostic Devices are regulated by the concerned State Drug Licensing Authority only.

Further, the following products are regulated as ‘Drugs’ under Drugs & Cosmetics Act & Rules there under: –

  1. Blood Grouping Sera
  2. Ligatures, Sutures and Staplers
  3. Intra Uterine Devices (Cu-T)
  4. Condoms
  5. Tubal Rings
  6. Surgical Dressings
  7. Umbilical tapes
  8. Blood/Blood Component Bags

In India import, manufacturing, sale and distribution of Notified Diagnostics Kits are regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945. At present the following Notified Diagnostics Kits are regulated under the said Act & Rules.

  1. In vitro Diagnostics Devices for HIV, HBV and HCV.
  2. In vitro Diagnostics Devices for HIV, HBV and HCV (Bulk)
  3. In vitro Blood Grouping Sera
  4. In vitro Blood Grouping Sera(Bulk)

For marketing of imported notified Medical Device and Diagnostic Kits in India, Registration Certificate in Form-41 and Import License in Form-10 are required under Drugs and Cosmetics Rules. The Rule 24-A, 25-B, 27-A and 28-A of Drugs and Cosmetics Rules, describe the information/data required for grant of registration certificate.

Brief Procedure to apply for the “Registration certificate” in Form-41 for Medical Devices in India is as follows. Steps may be adopted for Registration application-

  • STEP 1: Pay the required Registration fee through TR-6 Challan (in triplicate) with the application in Form 40
  • STEP 2.Compilation of Registration dossier as per the guidance documents
  • STEP 3.Submit Product Registration application at CDSCO (HQ), New Delhi

Rules Related to Registration of Notified Medical Devices and Diagnostic Kits in India

A.Form and manner of application for Registration Certificate (Rule-24A)

  1. An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself or by his authorized agent in India, with fee specified and undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the manufacturer.
  2. The authorization by a manufacturer to his agent in India shall be documented with 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 for 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.
  3. A fee of 1500 US dollar [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee and a fee of 1000 US dollars 1[or its equivalent in Indian rupees] shall be paid for the registration of a single drug meant for import into and use in India and an additional fee at the rate of 1000 US dollars for each additional drug. In the case any subsequent application for registration of additional drugs is made by the same manufacturer, the fee to accompanying the application shall be 1000 US dollars 1[or its equivalent in Indian rupees] for each drug.
  4. The fees shall be paid through a Challan in the Bank of Baroda, to be credited under the Head of Account “0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines”. In the case of any direct through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, 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.
  5. The applicant shall be liable to pay of a fee of 5000 US dollars [or its equivalent in Indian rupees] for expenditure, as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated by the licensing authority on its behalf under Rule 22.
  6. The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of drug.
  7. A fee of 300 US dollars [or its equivalent in Indian rupees] shall be paid for a duplicate copy of the
  8. Registration Certificate, if the original is defaced, damaged or lost.
  9. No Registration Certificate shall be required under these Rules in respect of an inactive bulk substance to be used for a drug formulation, with or without pharmacopoeial conformity.

B.Registration Certificate for import of drugs manufactured by one manufacturer (Rule 25B)

A single application may be made, and a single Registration Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer: Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit: Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.

C.Grant of Registration Certificate (Rule 27-A)

On receipt of an application for Registration Certificate in the Form and manner specified in Rule 24-A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, will issue a Registration Certificate in Form 41: Provided further that if the application is complete in all respects and information specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit.

If the applicant does not receive the Registration Certificate within the period as specified in the proviso to sub-rule (1), he may appeal to the Central Government and the Central Government may after such enquiry into the matter, as it considers necessary, pass such orders in relation thereto as it thinks fit.]

D.Duration of Registration Certificate (Rule 28-A)

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: Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.

E.Suspension and cancellation of Registration Certificate (Rule 29A)

If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause as to why such an order should not be passed, by an order in writing by stating in writing the reasons therefore, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:

Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.

Few Important points taken into consideration for Registration of Medical Devices and Diagnostic Kits:

  1. 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. 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/ Import License. Where any such change is 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.
  2. Acquisition/merger of one company by another company is considered as change in constitution of the company.
  3. Certificate of Exportability (which reflects that the proposed products may not be freely sold in the country of origin but can be exported), is not acceptable as Free Sale Certificate.
    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.
  4. Following changes do not require fresh registration and only notification or amendment may be obtained, provided proper justification is provided for the above changes.
  • 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

v. In case of change in the Indications and/ or Intended use of a registered notified medical device/IVD Kits, the applicant needs to submit a fresh application including Power of Attorney incorporating the changed Indications and/ or Intended use of the registered notified medical device. A revised Power of Attorney is required to be submitted, reflecting the changes/modification to indications. Checklist provided in module 10.

vi. The generic name of the medical device is the name as per the internationally accepted nomenclature for the medical device.

vii. 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.

viii. As per the Guidance document for Registration/ Re-registration, all certificates with minimum 6 months validity are to be submitted. However, if the applicant has a valid reason for not being able to submit the same within stipulated validity, they can provide an undertaking to the CDSCO stating that fresh certificates will be submitted immediately after expiry of such certificates and such instances will be dealt on a case to case basis as per rationale of reason.

ix. At the time of submitting applications for registration/ re-registration of medical devices/IVD kits, original labels as per Rule 96 to be submitted to the CDSCO. While original labels as per Rule 96 are required however applicants may submit coloured copy of original label incorporating all details as per Rule 96. Labels submitted should include all models for which registration is sought.

x. Mandatory addresses on the labels of registered notified medical devices/IVD Kits being imported/ marketed in India-

  • 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.

xi. The importers of registered notified medical devices/ IVD Kits are currently allowed to incorporate India-specific requirements like name and address of importer, import License Number on imported medical devices post landing in India at customs warehouse or place approved by the CDSCO prior to release into market. Shelf life of the IVDs can also be stated on the label instead of date of manufacture.

xii. Quality Manual as per ISO 13485 can be submitted in lieu of the Plant Master File, provided Quality Manual has same content as prescribed in Plant Master File.

xiii. The numbers of employees in the manufacturing premise are required to be included in the Plant Master File.The number of employees as on the date of preparation of Plant Master File will be considered for the purpose of registration. However, there may be a change in this number by the time the Plant Master File is collated and submitted.

xiv. If applicant wants to apply for Registration Certificate but the product is not being sold in any of the following countries i.e. USA, Europe, Japan, Health Canada or Australia, he cannot apply for Registration Certificate. However if safety and effectiveness of device is proven by conducting clinical trials in India, he can apply for registration certificate.

xv. 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, Health Canada or Australia, he can apply for Registration Certificate.

xvi. Adverse event, with medical device needs to be reported to CDSCO. To find out more about the adverse event reporting criteria, procedure and timeline, please refer to our website onhttp://cdsco.nic.in/pharmacovigilance.htm. If a recall or corrective action is required for any medical device, it needs to be reported to the CDSCO.

Feel free to contact us for any query or clarification

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

Disclaimer: Auriga Research Ltd has tried to arrange content in a simplified manner and accepts no liability for the content. For more updated information, Please visit CDSCO website or link provided above.