Importer Registration Of Medical Devices Under CDSCO

The Importer Registration of medical devices under CDSCO in India is very necessary for manufacturers. To enter the Indian market, manufacturers have to fulfill the standards of quality and efficiency to import into India. In India, you are only allowed to import medical devices when you have a medical device importer license under CDSCO. 

In India medical devices or products such as Cosmetics, Drugs, Medical Devices, and IVDs are regulated under the provision of the Drug & Cosmetics Act, 1940 and Rules, 1945. So, it is very necessary to obtain a medical device Importer Registration under CDSCO for the manufacturing, distribution, sale & import of commodities. After the registration under CDSCO, you can simply import medical devices into India.

What Is CDSCO?

The full form of CDSCO is the Central Drugs Standard Control Organisation. CDSCO is a national authority that is responsible for the approval and regulation of pharmaceuticals, medical devices, and cosmetics in India. The aim of the CDSCO is to confirm that the medical products available in the market are healthy & safe to use for consumers from the side of manufacturer, sale, distributor, or importer. For approval, you have to apply under the CDSCO registration for Importer Registration of medical devices.

Role Of Medical Device Regulation

CDSCO makes all the efforts to ensure that the only safe & effective medical devices enter the market. The list of medical device approvals is very large it includes everything from diagnostic equipment and surgical instruments to medical software.

Significance of Importer Registration Of Medical Devices

Importer Registration for medical devices is necessary for all those who are interested in regulating Medical products in the market. The significance of Importer Registration of medical devices are:-

• Ensure Quality and safety – Importer Registration of medical devices is a crucial step for the regulation of medical devices in the market. It ensures that the products imported into the market are safe and reliable to use by the consumer. It is important to reduce the risk of unsafe products in the market to patients and healthcare providers.
• Regulatory Compliance – It also ensures that the importers comply with the regulatory framework established under the CDSCO department.It is necessary for the importer to submit the documents and evidence of quality, safety, and effectiveness to ensure the medical devices they wish to import for Importer Registration of medical devices under CDSCO.
• Monitoring and Traceability – Through the Importer Registration the CDSCO can track the entry of medical devices in the market. It gives the traceability that the products in the Indian market are approved and ready to use for the consumers.

Type Of Medical Device In India

The medical devices in India are classified into two categories for better understanding during the time of MDR for importers.

• Notified Medical Devices – It is a list of medical devices that are regulated under the medical devices rules, 2017 by the CDSCO. If the notified devices are manufactured in India then the manufacturer must obtain a manufacturer license under the CDSCO. On the other hand, if the devices are manufactured outside India (Foreign Country) they must have a Medical device importer license. The list of new notified medical devices in India needs the manufacturer to submit the following documents such as like manufacturing site details, Manufacturer, device details, FSC (Free Sales Certificate), or CFS (Certificate of Free Sales).
• Non-Notified Medical Devices – These types of medical devices are listed in the portal of CDSCO. To sell and market these devices the manufacturer of foreign markets must have IAA based in India.

What Are The Risk Classification Of Indian Medical Device Importer Registration?

When you go for the registration you will find the various classes of medical devices. Each category of medical device have risk and here you will get to know about the classification of risk of Indian medical device for Importer Registration:-

Device Classes	Risk
Class A	Low Risk
Class B	Low Moderate Risk
Class C	Average Risk
Class D	High Risk

List Of Regulatory Bodies Responsible For Medical Device Importer Registration

In the Importer Registration of medical devices few regulatory bodies are accountable are as follows:-

1. Drug Controller General of India (DCGI)
2. CDSCO (Central Drug Standards Control Organisation)
3. Drugs & Cosmetic Acts and Rules (In India, the import, manufacturing, sale & distribution of different medical devices are regulated under the mentioned act)

Who Can Apply For Importer Registration Medical Device Under CDSCO?

Under the CDSCO act authorized Indian agents can apply for the import license. The manufacturer can apply for it for sale & distribution but must have manufacturer license. The wholesaler can apply for the sale & distribution of importer licenses of medical devices under CDSCO. The agents just have a file an application to get a medical device import license.

Process Of Importer Registration Of Medical Devices Under CDSCO

To apply for the Importer Registration of medical devices under CDSCO you have to follow the basic steps. Simply follow these steps and apply for it now:-

Step 1 – The person who wants to import medical devices or in vitro devices into India from any foreign nation, shall apply for an importer license to the central licensing Authority by Form MD –14 for all risk-category medical devices.

Step 2 – The fee must be paid with the application form to the CDSCO medical devices registration import license fee. It is paid with the premises or unit where the manufacturer aims to import the medical devices.

Step 3 – On receipt of the application, the central licensing Authority shall determine the quantity of the medical devices, after taking into account the requirement for clinical investigation, approve the clinical investigation plan and information, and check all documents submitted by an applicant.

Step 4 – After such inquiry, if the central licensing Authority is satisfied then issue a grant of import licence in MD-15. In case if central licensing Authority rejects the application, and raises the query then the applicant needs to reply to the queries by providing appropriate documents according to the guidelines under CDSCO.

List of Information Required in The Form Or Application Of CDSCO Medical Device Registration

When you fill out the form it requires the following information that is necessary to get a medical device FDA importer license in India under CDSCO.

Application Details

• Applicant’s Company name, address, and contact details.
• Foreign manufacturer Address and name
• Plant Master File Copy
• Importer Name and address
• Local authorized representative name & address
• Local Manufacturer for the processing within a country.

Product Information

• Brand or Proprietary name
• Device category
• Method and intended use
• Device brief description
• Manufacturing method brief description 
• Specification of the materials used
• Variations in style, size, or shape of the device, if applicable
• Recommended Storage conditions
• Warnings, contraindications, precautions for potential adverse events and alternative therapy, wherever applicable
• Summary indications of any reported problems
• Quantitative & qualitative particulars of the constituents
• Details of standards to which the device conforms along with a copy of the standard
• List of accessories & other devices or equipment to be used in combination with the device. 
• Information comprising accessories packaged with the product
• Packaging description comprising pack sizes
• Labeling details conforming to Drugs & Cosmetics Rules, 1945
• Promotional Literature & Physician Manual in English
• Medical specialty in which the device is used.

Regulatory Status

• Approval of product from any other agency
• EU medical device directive (CE Certificate).
• Approval in any other country

US FDA Approval or Clearance

• Approval Of Japan Australia, or Canada.
• Nations List where the device is being sold.
• If any, for the manufacturing facility Copy of EN or ISO Certification
• List of countries where the device is withdrawn from sale with reasons, if any.

Master File 

• The shelf life of the device
• Device Master File
• Functionality Test protocol & report ( if applicable)
• Stability data /statement of established material used
• Manufacturing process flow chart
• Risk Assessment as per ISO 14971
• Quality Assurance procedures or Process Controls
• Sterilization process & Verification or Validation
• Device GMP Certificate
• Material or Component used
• Final product testing/design inputs & outputs verification, if applicable
• Biocompatibility and toxicological data, wherever applicable.

Devices Containing Medicinal Products:

• For mеdical dеvicеs that havе not bееn grantеd authorization for markеting within thе country,  thе applicant must provide a comprеhеnsivе sеt of documents.  This includes clinical trial rеports,  information on salеs,  еndorsеmеnts from mеdical spеcialists confirming thе dеvicе’s satisfactory usе,  and any rеcords of product complaints if applicablе. 
• If thе mеdical dеvicе incorporatеs a mеdicinal product that has an impact on thе body,  thе submission should also address thе safety,  quality,  and еfficacy of thе mеdicinal substancе usеd. 
• Additionally,  if thе dеvicе contains any mеdicinal substancеs of animal origin,  a Batch Rеlеasе Cеrtificatе must bе providеd. 
• For dеvicеs dеsignеd to administеr mеdicinal products,  data rеgarding thеir compatibility with thеsе mеdicinal itеms or products should bе includеd. 
• It’s important to notе that mеdical dеvicеs that havе rеcеivеd prior consеnt from rеcognizеd rеgulatory authoritiеs will undеrgo a strеamlinеd еvaluation procеss,  whеrе only a summary of thе studiеs and dеtails mеntionеd abovе nееds to bе submittеd.  

Post-Market Surveillance:

• Handling of complaints
• Procedures for distribution of records
• Procedure for product recall
• Adverse incident reporting.

List Of Documents Required For Importer Registration

For the Importer Registration of medical devices following documents are required:-

• Duly apostilled/notarized copy of the Free Sale Certificate/Marketing Authorization of the product from the National Regulatory Authority of the country of origin.
• Duly apostilled/notarized copy of Free Sale Certificate Marketing Authorization of the product from the National Regulatory Authority of any of the following countries viz USA, EU, Canada, Japan, Australia. 
• Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within the last 3 years 
• Notarized copy of Certificate supporting quality management system (ISO: 13485)- It’s available, just need a notarized copy 
• Notarized Full Quality Assurance Certificate/CE type examination Certificate/CE product quality assurance- It’s available, just need a notarized copy 
• Notarized CE Design Certificate 
• Notarized Declaration of Conformity 
• Plant Master file from the Manufacturer as specified in Appendix 1 of the Fourth Schedule of Medical Devices Rules 
• Device Master file from the Manufacturer as specified in Appendix II of the Fourth Schedule of Medical Devices Rules.- Technical file available, need all appendices mentioned in technical file to prepare DMF 
• Label- importer name and address, Lot no., net quantity,mfg. date 
• Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority 
• Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority 
• Copy of Selling & Distribution license of 
• Government Fees For Importer Registration
• Validity for Import Licence of Medical Device
• FDA medical device license is valid for 5 years (Class A, B, C & D) When the import license expires, the Importer has to renew his/her license. For renewal there is no need for all documents, only an old import license and fee challan are required.

For How Many Days Medical Device Import License Is Valid?

The FDA importer medical device license is valid permanently just you have to pay a fee of it every 5 years. If you do not pay the fee then the license will be suspended or canceled by the Central Licensing Authority (CLA).

Exemption Of Class A Medical Devices From Obtaining MD-15 (Latest Notification Of Class A Non-Sterile & Non-Measuring)

As per the Final notification by CDSCO, if one wants to import a medical device that is class A nonsterile and non-measuring now no longer needs a registration under MD-15.

They can proceed with a voluntary registration number which can be obtained with the help of the ELT Corporate Medilaw Team.

Frequently Asked Questions