Introduction: Medical Devices

India is one of the developing countries that is expected to reach the highest level of development in the world in a short time, and the ability of Indians to deliver drugs and medical equipment has been gaining popularity around the world for decades. In the past decades, India has made significant progress in the field of medicine. Given the progress that has been made, India is now becoming an area where countries having expertise in the field of medicine are now willing to invest in India and use Indian services. This may sound exciting and beneficial, but it may also be dangerous in India if the import or manufacture of any medicine or equipment is left unchecked.

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The Government of India has set up the Central Drugs Standard Control Organization, a national regulatory body headed by the Directorate-General for Health Services, under the auspices of the Department of Health and Family Welfare, to address the deficiencies. In India, CDSCO is the Food and Drug Administration of the United States, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, the European Medicines Agency of the European Union and the PMDA of Japan. Nowadays, everything is changing, including diseases and the fight against any new or existing diseases, it is very important to make new medicines, and before any such drugs are produced and distributed, it is important to ensure that they do not hurt in any way. This is where CDSCO comes in, focused on improving people.

Central Drug Standard Control Organisation (CDSCO) is the authority that is responsible for import of medical devices. One such way of obtaining license in form MD-14. Any device intended to be used for medical purposes shall be a medical device. Medical devices benefit patients by helping health care providers diagnose and treat patients and help patients overcome illness and disease and improve their quality of life. Significant potential for hazards is inherent when a device is used for medical purposes and therefore medical devices must be shown to be safe and effective with reasonable assurance before governments allow the device to be placed on the market in their country. Medical Device Rules defines medical devices as

• substances used for in vitro diagnostics and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component bags with or without anticoagulants 
• substances including mechanical contraceptives (condoms, intrauterine devices, tube rings), disinfectants and insecticides notified in the Official Gazette, 

Regulation of all medical devices are under New Medical Rules 2017. For the purpose of import of medical devices, certain license is also required by the CDSCO in the Form MD-14.

Form MD-14 is the application made for the purpose of grant of import license. Any authorized agent in possession of a license to manufacture for sale or distribution or wholesale license for sale or distribution may apply by filing an application for grant of import license for medical device in Form MD-14 to the Central Licensing Authority. For this purpose, online portal of the Ministry of Health and Family Welfare is identified in the Central Government. This application shall be submitted along with the prescribed fee and requisite documents. Prescribed fee is as follows:-

• Import license for Class a medical devices other than In vitro diagnostic medical device – For one site is $ 1000 and for each distinct medical device $ 500.
• Import license for Class B medical devices other than In vitro diagnostic medical device – For one site is $ 2000 and for each distinct medical device $ 500.
• Import license for Class C or Class D medical devices other than In vitro diagnostic medical device – For one site is $ 3000 and for each distinct medical device $ 1500.
• Import license for class A or class B in vitro diagnostic medical device – For one site is $ 1000 and for each distinct in vitro medical device is $ 10.
• Import license for class C or class D in vitro diagnostic medical device – For one site is $ 3000 and for each distinct in vitro medical device is $ 500.

The said application shall be submitted along with the fee and requisite documents according to the basis of medical devices. Requisite documents according to the basis of medical device is mentioned in the fourth schedule of the Medical devices rules. If any document of the applicant undergoes any change from the time of submitting application and prior to the grant of the license, the same shall be recorded in writing with the Central Licensing Authority.

If after scrutiny of application, Central Licensing Authority believes that the medical device’s quality is compromised and comes to the decision where subjecting it to evaluation, test or examination, the authorized agent will be liable to pay a fee the said evaluation, test or examination to the testing laboratory specified by the Central Licensing Authority.

If any subsequent application is filed for grant of license for an additional manufacturing site by the same authorized agent for the same medical device is filed. It shall be accompanied with the prescribed fee mentioned above and documents prescribed in fourth schedule of medical device rules.

Or any license for any additional medical device manufactured at the same manufacturing site shall be submitted by the same authorized agent submitted shall be made along with the prescribed fee as mentioned above and documents mentioned in the Fourth Schedule of Medical device rules.  

Grant of License

After scrutiny of application and documents furnished by the applicant in the Form MD-14 and on basis of the report of inspection, in case inspection is carried out, Central Licensing Authority within period of Nine months may grant the license or may reject the same recording the reasons in writing. License, if granted, will be in form MD-15.

If, in any case, application is rejected. The applicant has the right to appeal within 45 days to the Central Government and after necessary enquiry, Central Government within ninety days will pass the orders in relation thereto.

Clinical investigation isn’t needed and the license will be granted if any medical devices has a free sale certificate issued by national regulatory authority or other competent authority of any of the countries namely, Canada, Japan, Australia, United States of America and European Union Countries. For any medical device imported from any other country other than these countries mentioned here, clinical investigation in India is necessary to establish safety and effectiveness in furtherance of the license for class C and class D medical devices. And if the class of medical device is class A or class B, its safety and performance will be deemed to be established after clinical investigation in the country of origin and furnishing of certificate of free sale from the country of origin or safety and performance data.

The applicant is required to obtain prior permission from the Central Authority in form MD-27 or in form MD-29 in case of investigational medical device or new In vitro diagnostic medical device and no license will be granted without any such permission.

Conditions imposed of License holder

• The licensee shall comply with the following conditions, namely: the license shall be issued upon request by the Medical Device Officer or any other senior officer under the control of the Central Licensing Authority or the State Licensing Authority;
• the licensee shall immediately inform the licensing authority and, in any event, within a period of 15 days of any administrative action taken on the basis of any adverse reaction, such as withdrawal from the market, regulatory restrictions, cancelation of authorisation or declaration of a medical device as not a quality standard by the regulatory authority of the country of origin or by any regulatory authority of any other country where the medical device is marketed, sold or distributed;
• The authorized agent shall, in the cases referred to in paragraph (ii), immediately stop the dispatch and marketing of the medical device referred to in that clause;
• The Central Licensing Authority may, after due consideration of the information referred to in paragraph (ii), issue instructions to the licensee regarding the marketing, sale or distribution of medical devices, including the withdrawal of medical devices from the Indian market, within a period as may be specified by the Central Licensing Authority;
• The authorized agent shall obtain prior approval from the Central Licensing Authority prior to any major change, as set out in the Sixth Schedule of the medical device rules, and the Central Licensing Authority shall indicate its approval or refusal within sixty days;
• In the event that no notification of approval or refusal as referred to in clause (v) is received by the Central Licensing Authority within the time specified, such amendment shall be deemed to have been approved;
•  Licensee shall inform the Central Licensing Authority THE GAZETTE OF INDIA of any minor change as specified in the Sixth Schedule: EXTRAORDINARY [PART II—SEC. 3(i) within a period of thirty days after such minor change has taken place;
• The authorized agent shall inform the Central Licensing Authority in writing, within a period of thirty days, of any change in the constitution of the overseas manufacturer or authorized agent;
• The shipment of medical devices shall be accompanied by an invoice or a statement indicating the name and quantity of the medical device;
• The licensee shall, where applicable, supply the medical device for sale or offer it for sale along with its package insert or user manual.

Where the Central Licensing Authority is satisfied that any medical device is not in conformity with the provisions of the Act and these rules, it may issue instructions that the whole lot of such medical device may not be sold or offered for sale or that it may be withdrawn from the market, including hospitals, if any, where it has been stored: provided that where the Central Licensing Authority considers that it is appropriate to do so.

Read Our Blog: Import Medical Devices in India

Bottom-Line

CDSCO License is necessary to be granted for the purpose of import of medical devices. To obtain the said license, it is necessary that the requisite documents, fee and other conditions are fulfilled and it is advised that the procedure be proceeded further using help from the experts as the procedure may be exhausting and a little problematic for anyone. License is mandatory to be obtained prior to import of medical devices as failure in obtaining such license would create hassles for the person importing medical devices.