Medical Device: Medical devices are defined in the statute as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory that is intended for use in the diagnosis of a disease or other conditions or in the treatment, mitigation, treatment or prevention of disease. Medical devices help in identifying the disease in the human body as well as in animals. In India, at present only notified medical devices are regulated as drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical stitches, surgical sutures, ligatures, storage bag of blood and blood components, covered by the sub-clause(i), with or without anticoagulant.
Mechanical contraception (condoms, intrauterine devices and tubal rings), disinfectants, and insecticides mentioned under the sub-clause (ii).
Devices mentioned under subclause (IV), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, from time to time
For import of medical devices and IVD kits in India, it should be registered under (Form 41) and import license in( Form 10 )is required under Indian Drug Regulatory authority the manufacturing of medical devices should be registered. But for the import of Non- Notified IVD kits/reagents in India, only Import License in Form 10 is required. Any firm holding a valid license under the Drug & Cosmetics Act.1940and Rule 1945 can become an applicant and apply both registration certificate (form 41) and import license (Form 10), provide Indian agent & importer for the same.
Indian Authorization Agent has to be appointed by the manufacturer for the registration process. It takes 6-9 months for all the medical to get registered. Manufacturer who has home approval (FDA or CE) can use them to leverage their device registration India, whereas the validity of the certificate is for 3years and need to be applied within 6-9months prior to its expiry.
REGISTRATION OF MEDICAL DEVICE FOR IMPORTING:
Registration certificate is required to take the permission for device manufacturing and for importing in India.
Government fees are needed to be paid along with the application for manufacturing devices or Importing.
For single medical device govt. fees need to be paid according to the shape, size, and material or method of use, where additional fees will be added.
The fees should pay through challan under guidelines.
The information and undertakings needed to be given in compliance with Schedules DI and DII may be changed to comply with the specifications of devices in place of ordinary pharmacological items.
The import license is used by the importer upon a grant of the RC Certificate.
Device name:
Condition under Form10 and Form 10A (Rule 25A)
The imported substance should be properly stored and preserved the drug to which the license applies.
The occupation, trade, or business ordinarily carried by the applicant may get refuse under Form10.
His conviction under the Act or these Regulations or the Act on Narcotic Drugs and Psychotropic Substances, 1985 (61 of 1985) or the rules set out therein.
Condition under import license under (Rule 26)
The manufacturer should sign the undertaking given by him under Form9.
The sample will be collected by the authority who will visit for inspection and the process for the examination will be started according to the protocol of testing is applied
A direct licensing authority shall not sell or offer for sale until a certificate authorization has to be issued by licensing authority .the same protocols are furnished or shall apply to the last proceeding sub-rule.
The record should be maintained of sale substance for which import license is required. You also need to show the records to whom you have sold as an inspection can be done any time under the authority.
Maintain the following particulars under schedule X in respect of sales and distribution of drugs.
Drug name
Batch number
Name & address of the manufacturer
Date of transaction
Stock of business
Quality of drug and source received
Name of the purchaser, address, and license number
Balance quantity of drug at the end of the business
Signature of the person under whose supervision the drugs have been supplied
Read about: CDSCO License