Regulation for Import of Notified Medical Devices and Diagnostic Kits in India

Module 4

For the import of Notified Medical Devices and IVD kits/reagents in India, Registration Certificate in Form 41 and Import License in Form 10 are required. For import of Notified Medical Devices and IVD kits/reagents, the manufacturing site and products (IVD kits/reagents) are required to be registered with Indian Drug Regulatory Authority (i.e. CDSCO). But for the import of Non- Notified IVD kits/reagents in India, only Import License in Form 10 is required. Any person/firm/enterprise etc. holding a valid wholesale license and/or manufacturing license issued under Drugs and Cosmetics Act, 1940 and Rules 1945 can be an applicant for Registration and Import of IVD kits and reagents into India. An applicant can apply for both Registration Certificate (Form 41) and Import License (Form 10) together, provided Indian agent and importer are the same.

Following steps may be adopted for Registration application in Form-41 for Notified Medical Devices and IVD kits/reagents in India

STEP 1. Pay the required Registration fee through TR-6 Challan (in triplicate) along with the application in Form 40 for the manufacturing premises meant for manufacturing of Notified IVD kits/reagents intended for import into and use in India.

STEP 2. Compilation of Registration dossier as per the guidance documents

STEP 3. Submit Product Registration application at CDSCO (HQ), New Delhi

Registration Certificate and Import Licence are required to import components of Medical Devices. Devices in assembled form ready for packaging and sterilization are regulated under the provision of Drugs and Cosmetic Act 1940 and Rules thereunder. Hence Registration Certificate and Import License are required for import into India.

Import of Medical Devices and Diagnostic Kits in India:

A. Import licences (Rule-23)

An import licence in Form 10 shall be required for import of drugs, excluding those specified in Schedule X, and an import licence in Form 10-A is required for the import of drugs specified in Schedule X.

B. Form and manner of application for import licence (Rule-24)

1. An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule X, either by the manufacturer himself or by the manufacturer’s agent in India and shall be accompanied by a licence fee of Rs.1000 for a single drug and an additional fee at the rate of Rs.100 for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer: Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be Rs. 100 for each drug.

2. Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under Rule 27-A: Provided that in case of emergencies the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10-A, as the case may be, without the issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing.

Provided further that Registration certificate is not required to be accompanied with an application for an import licence under the Rules for the import of in-vitro diagnostic kits and regents, except for the diagnostic kits notified from time to time under sub-clause (iv) of clause (b) of section 3.

3. A fee of Rs. 250 shall be paid for a duplicate copy of the licence issued under this Rule, if the original is defaced, damaged or lost.

C. Licences for import of drugs manufactured by one manufacturer (Rule 25)

A single application may be made, and a single licence 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 drugs 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 a separate licence shall be required in respect of the drugs manufactured by each such factory

D. Condition to be satisfied before a licence in Form 10 or Form 10-A is granted (Rule 25A)

1. A licence in Form 10 or in Form 10-A shall be granted by the licensing authority regarded that:

  1. The premises, where the imported substances are stocked, are equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies; and
  2. The occupation, trade or business ordinarily carried out by the applicant: The licensing authority may refuse to grant a licence in Form 10-A in respect of any applicant where he is satisfied,–

a. That the applicant has not complied with the provisions of the Act or these rules; or

b. That by reasons of—

  1. His being convicted under the Act or these Rules or the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) or the rules made there under
  2. Previous suspension or cancellation of the licence granted to him; as he is convinced as not being a fit person to whom license shall be granted.

2. Any 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 making a representation in the matter, may make such orders in relation thereto as it thinks fit.

E. Conditions of import licence (Rule 26)

An import licence shall be subject to the following conditions:

  1. The manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9;
  2. the licensee shall allow any Inspector authorized by the licensing authority to enter with or without notice any premises where the imported substance is stocked, to inspect the means, if any, employed for testing the substance and to take samples;
  3. the licensee shall, on request, furnish to the licensing authority from every batch of each substance, or from such batch or batches as the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so required, furnish full protocols of the tests, if any, which have been applied;
  4. if the licensing authority so directs the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding sub-rule until a certificate, authorizing the sale of the batch, has been issued to him by or on behalf of the licensing authority;
  5. the licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority as not conforming with the standards of strength, quality and purity prescribed by Chapter III of the Act, or the rules thereunder and on being directed so to do, withdraw the remainder of that batch from sale and, so far as may in the particular circumstances of the case be practicable, recall from the batch those that are already issued;
  6. the licensee shall maintain a record of all sales by him of substances for the import of which a licence is required, showing particulars of the substance and of the person to whom sold and such further particulars, if any, as the licensing authority may specify and such record shall be open to the inspection of any Inspector authorized on that behalf by the licensing authority:

Provided that in respect of the sale or distribution of drugs specified in Schedule X, the licensee shall maintain a separate record or register showing the following particulars, namely:

  1. Name of the Drug,
  2. Batch number,
  3. Name and address of the manufacturer,
  4. Date of transaction,
  5. Opening stock on the business day,
  6. Quantity of drug received, if any, and the source from which received,
  7. Name of the purchaser, his address and licence number,
  8. Balance quantity of drug at the end of the business day,
  9. Signature of the person under whose supervision the drugs have been supplied

vii. the licensee shall comply with such further requirements, if any, applicable to the holders of import licenses, as may be specified in any Rules, subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than four months’ notice.

F. Grant of import licence (Rule 27)

On receipt of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 [or From 10-A, as the case may be].

G. Duration of import licence (Rule 28)

A licence 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 application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.

H. Suspension and cancellation of import licence (Rule 29)

If the manufacturer or licensee fails to comply with any of the conditions of an import licence, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons there for, suspend or cancel it 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 Import of Medical Devices and Diagnostic Kits:

I. The mandatory addresses on the labels of registered notified medical devices being imported/ marketed in India as per the Drugs and Cosmetics Act, 1940-

  1. Name and address of Legal Manufacturer,
  2. Actual manufacturer and importer as stated in Form-10

II. A Single license may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer to the Importer through which importer can import the products through any notified port. For importing some more products from the same manufacturer on existing valid import license, Importer has to apply for endorsements to the existing import license along with the requisite documents including copy of the existing import license and fees. Applicant is required to submit separate fee for each of the categories like test strip, cassettes, midstream, etc.

III. Free Sale Certificate issued by the National Regulatory agency for the purpose of registration / Import of Diagnostic Kits/Reagents in India should have actual manufacture’s name and address.

IV.Importer who has a valid Form-10 license but there is a small change in the name of importer or address of importer still he can import till another license is granted but at the time of import, the label of the product should comply with details as specified in the Form-10 for the product.

V. Applicant is required to submit performance evaluation report for 3 lots of Notified IVD kits/reagents during the submission of application for registration certificate and evaluation shall be carried out at the National Institute of Biologicals, Noida. In cases where Closed System/Testing facilities are not available in NlB, Noida, CDSCO may consider approval of alternate laboratories like CMC Vellore, NIV Pune, AllMS, Nizam institute of Medial Sciences (NIMS) or other Govt. institutes of national repute for testing purposes of Notified in-Vitro Diagnostic Devices on case to case basis.

VI. Applicant has to mention the specific intended use of the proposed product in the product list matching with product insert / brochure, in not more than 50 words.

VII. For Non Notified diagnostics kits/reagents, need Performance Evaluation reports are needed for 3 batches from India for import license also required for only IVD Kits/reagents intended for Malaria, TB, Dengue, Chikunguniya, Typhoid, Syphilis and Cancer. It can be performed by Any Govt. institutes of National repute or any other NABL, CAP, NABH accredited Laboratory/Institute in India. These kits should comply with the Clinical sensitivity, specificity, standards etc. as declared in the IFU/COA/Product insert issued by the manufacturer. Below is a web-link for some laboratories for the testing and evaluation of these kits. –

VIII. National Institute of Biological (NIB), Noida has standardized and validated the various recommended procedures required for quality evaluation of following Rare Blood Grouping Reagents and also mentions the volume required for the testing of these reagents.

IX. Typically a Performance Evaluation Report should mention following details: Product name, lot / Batch number, manufacturer’s name, importer name, import / Test licenses number, number of samples tested, testing principle (ELISA/Rapid/NAAT, etc.,), information about reference used, Testing procedure, Specificity, Sensitivity, Positive predictive value, Negative predictive value, Report number, Date of analysis, designation & signature of analyst and authorized signatory of the laboratory etc.

X. The criterion for evaluation of Rapid & ELISA (HIV, HBsAg, HCV) Diagnostic kit adopted by NIB, Noida is as below

  • Anti-HIV Rapid/ELISA Sensitivity (%) ≥99.5 Sensitivity (%) ≥98
  • HBsAg Rapid/ELISA Sensitivity (%) ≥99 &0.5ng/ml Sensitivity (%) ≥98
  • HCV Rapid/ELISA Sensitivity (%) ≥99.5 Sensitivity (%) ≥98

XI. Here are examples of few kits not regulated for import under Drug and Cosmetic Acts & Rules

  • Kit intended for use in determining the presence of host cell protein contamination, in products manufactured by expression in the CHO cell line and other technology for research and manufacturing use only and is not intended for diagnostic use in humans or animals.
  • In – Vitro diagnostic kits / reagents used in determining the presence of histamine, drugs substances , Microbial detection in food & food products, animal feeds, liquor (wine, beer), environmental samples like water & soil etc.
  • Empty Specimen collection tubes without needle used for the collection of Blood, Urine, Stool, Sputum, Semen, etc. for purpose of specimen collection
  • Import of raw material for diagnostic kits & reagents which are further used in the manufacturing of the finished in vitro diagnostic kits.
  • In-vitro diagnostic kits/reagents /samples intended for research use only, for the purpose of Accreditation / Certification of Hospital/Laboratories like College of American Pathologists (CAP) Accreditation, etc. and for External Quality Assurance (EQAS) during import. But uncut sheets/semi-finished diagnostic kit, Bulk reagents like Calibrators, controls, diluents are being regulated for Import.
  • Glucometers used for blood glucose monitor (instrument) are not regulated. However, test strips and reagents are regulated.

Such cases may be examined and released at the level of ADC (I)/Incharge/Port officer of CDSCO without referring NOC from CDSCO (HQ).

XII. Any In-Vitro diagnostic Kits / Reagents that are intended for use in a clinical investigation or clinical diagnostic use outside an investigation (for example, in clinical diagnosis) should not be considered Research Use Only (RUO).

XIII. Only “Serodiagnostic test kits for diagnosis of tuberculosis” are prohibited for Import, Manufacture, Sale, Distribution and Use in the country under Section 10A and Section 26A of the Gazette notification(s) GSR432 (E) & GSR433 (E) dated June 7, 2012.

XIV. Permission under Rule 37 of the Drugs and Cosmetics Act is not required for import of reagents in bulk packs under Form 10 license mentioning Bulk or the use of product in manufacturing however, in such cases, the exemption is only applicable if the applicant holds the valid manufacturing license for the finished product.

XV. NOC from the office of DCGI is required for the approval of manufacturing license from the state licensing authority for the Notified diagnostic kits / reagents and new diagnostic kits / reagents (First in India) on the basis of examination of the following documents:-

  • Detailed manufacturing process.
  • Developmental studies.
  • Stability data
  • Testing protocols for raw materials and finished products
  • In- house specification
  • Labeling Details
  • Evaluation Reports.
  • Experts opinion (First in India) etc.

XVI. Import of the IVDs and Medical Devices with brand name in case the Import License (Form-10) reflecting the product (IVDs) with generic name or vice versa is not acceptable. A regulatory requirement for Import, Manufacture and labeling of Veterinary IVDs is same as IVDs meant for human beings.

XVII. ISO Symbols can be incorporated on the labels of registered notified medical devices being imported into India. The ISO Symbols are acceptable on labels of registered notified medical devices being imported into India.

XVIII. For some In-Vitro diagnostic Kits / Reagents NOC from department of Animal Husbandry, Dairying and Fisheries (DADF), Government of India, Krishi Bhavan, New Delhi in respect of products intended for veterinary purpose and NOC from DG, ICMR, New Delhi for the product intended for influenza

XIX. Products imported under valid import license can stock in any other wholesale license premises other than stated in the Import License.

XX. No registration requirement for notified products imported and locally processed for 100% export only and which will not be marketed in India. However the importer shall comply with requirements specified by DGFT from time to time.

Feel free to contact us for any query or clarification

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.