Importing Notified Medical Devices and IVD kits/reagents into India requires a Registration Certificate in Form 41 and an Import of diagnostic devices License in Form 10. To import Notified Medical Devices and IVD kits/reagents, the manufacturing site and goods (IVD kits/reagents) must be licenced with the Indian Drug Regulatory Authority (i.e. CDSCO). Importing Non-Notified IVD kits/reagents into India needs only an Import License in Form 10. Anyone with a valid wholesale and/or manufacturing licence issued under the Drugs and Cosmetics Act, 1940 and Rules 1945 may apply for IVD kit and reagent registration and import into India. If the Indian agent and importer are the same, an applicant may apply for both the Registration Certificate (Form 41) and the Import License (Form 10) at the same time.
In India, the steps for submitting a registration application in Form-41 for Notified Medical Devices and IVD kits/reagents are as follows.
Step 1: Pay the required Registration fee, along with the Form 40 application for the manufacturing premises for Notified IVD kits/reagents intended for import into and use in India, via TR-6 Challan (in triplicate).
Step 2: Compilation of the Registration dossier in accordance with the guidelines
Step 3: Submit an application for product registration to CDSCO (HQ) in New Delhi.
A Registration Certificate and an Import License are required when importing medical device components. The Drugs and Cosmetics Act of 1940 and its Rules govern devices in assembled form that are ready for packaging and sterilization. As a result, for import into India, a Registration Certificate and an Import License are required.
Import of Diagnostic Devices in India
A. Import permits (Rule-23)
For the import of drugs not included in Schedule X, a Form 10 import licence is required, and a Form 10-A import licence is required for the import of drugs included in Schedule X.
B. Format and process for importing software licences (Rule-24)
1. The manufacturer or the manufacturer's agent in India must apply to the licencing authority an application for an import licence in Form 8 for drugs not specified in Schedule X and Form 8-A for drugs listed in Schedule X, along with a licence fee of Rs.1000 for a single drug and an additional fee of Rs.100 for each additional drug. Provided, however, that any subsequent application for an import licence by the same importer for drugs produced by the same manufacturer shall be accompanied by a charge of Rs. 100 for each prescription.
2. A copy of the Registration Certificate issued in Form 41 under Rule 27-A must be attached to any Form 8 or Form 8-A application for an import licence. In the event of an emergency, the licencing authority can issue an import licence in Form 10 or 10-A, as appropriate, without issuing a Registration Certificate under the Act.
Furthermore, except for the diagnostic kits notified from time to time under sub-clause (iv) of clause (b) of section 3 of the Rules for the import of in-vitro diagnostic kits and regents, a registration certificate is not necessary to be submitted with an application for an import licence under the Rules for the import of in-vitro diagnostic kits and regents.
3. If the original of the licence given under this Rule is defaced, destroyed, or lost, a charge of Rs. 250 must be charged for a duplicate copy.
C. Export licences for drugs made by a single manufacturer (Rule 25)
For the importation of more than one drug or class of drugs produced by the same manufacturer, a single application is needed and licence can be submitted: Assuming that the drugs or groups of drugs are produced in a single factory or several factories working together as a single production unit:
Furthermore, if a single company has two or more factories located in different locations, each of which manufactures the same or different drugs, each factory's drugs would need a separate licence.
D. Before a Form 10 or Form 10-A licence is issued, a condition must be met (Rule 25A)
1. The licencing authority can issue a Form 10 or Form 10-A licence if the following conditions are met:
I. The storage facilities where the imported substances are kept are adequate for preserving the properties of the goods protected by the licence; and
II. The applicant's usual occupation, trade, or business: If the licencing authority is pleased, he can refuse to grant a Form 10-A licence to any applicant.
a. That the applicant has failed to comply with the Act's or these laws' provisions; or
b. That, as a result of—
I. Prior suspension or revocation of his licence, if he is found not to be a suitable person to whom a licence should be issued, under the Act or these Laws,
II. or the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), or the rules made there under
2. Any person who is aggrieved by a licencing authority's order under this Rule may file an appeal with the Central Government within thirty days of receiving the order, and the Central Government, after conducting such an investigation as it deems necessary and providing the appellant with an opportunity to make a representation in the matter, may make such orders as it deems appropriate.
E. Import license conditions (Rule 26)
The following conditions must be met in order to obtain an import license:
I. At all times, the producer must abide by the undertaking he or someone acting on his behalf given in Form 9.
II. Any inspector licensed by the licensing authority has the authority to enter any premises where the imported drug is stocked, with or without notice, to inspect the testing means, if any, and to take samples.;
III. The import of medical devices license shall provide to the licensing authority, upon request, a sample of such amount as the licensing authority may consider adequate for any examination required to be made from each batch of each drug, or from such batch or batches as the licensing authority can determine from time to time, and the licensee shall, if so necessary, provide complete protocols of any tests performed.
IV. If the licensing authority so directs, the licensee can not sell or offer for sale any batch for which a sample or protocols were given under the preceding sub-rule until the licensing authority has issued him a certificate authorizing the sale of the batch.
V. When the licensing authority notifies the licensee that any part of a batch of the product has been found to be in breach of the strength, consistency, or purity requirements specified by Chapter III of the Act or its regulations, and when guided to do so, the licensee shall remove the remainder of that batch from sale and return it to the licensing authority, to the extent possible in the particular case, return it to the licensing authority.
VI. The licensee must keep track of all sales of drugs that require a license, including the product and the person to whom it was sold, as well as other information as any other details the licensing authority might require, and this record must be available to review by any Inspector designated by the licensing authority to that end:
However, if the licensee is selling or delivering Schedule X medications, the licensee must maintain a separate record or register that includes the following details.;
Name of the Drug,
Date of transaction,
Batch number,
Balance quantity of drug at the end of the business day,
Name and address of the manufacturer,
Signature of the person under whose supervision the drugs have been supplied
Opening stock on the business day,
Quantity of drug received, if any, and the source from which received,
Name of the purchaser, his address and licence number,
VII. The license must comply with any additional conditions imposed on holders of import licences in any Rules enacted later under Chapter III in the Act, of which he has been given at least four months' notice by the licencing authority.
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