Applying for an MD-15 Import License for Medical Devices in India

To apply for an MD-15 Import License in India, manufacturers must abide by the medical device regulations of the Central Drug Standard Control Organization (CDSCO). The Medical Device Rules, 2017 have been implemented in India since 1st January 2018. Originally there was a list of 37 medical devices that were regulated- now all medical devices and IVDs have to be classified and obtain an Importer License as Class A, Class B, Class C, or Class D for selling into the Indian Market. For Class C and Class D Medical Devices and IVDs which do not fall under the original list of 37 regulated products, the CDSCO had given an extension of the deadline till 30th September 2023 to comply with the licensing requirements. 

In India, the Authorized Indian Agent is also the Legal Importer. Application is made in an MD-14 form and the license granted by the CDSCO is the MD-15 Import License. Hence the holder of the MD-15 license is also the Importer of the medical device in India.

To apply for an Import License, the following steps are required: 

1. 1. 1. Power of attorney to the Indian Agent 
      2. MD-14 application form on the SUGAM portal of the Indian Agent 
      3. Submission of documents based on class once the MD-14 form is generated 
      4. Payment of fees 
      5. Responding to queries 
      6. Medical Device Advisory Committee (MDAC) review for novel products 
      7. Obtaining the Import License in MD-15 
      8. Exporting medical devices to India 

Document Requirements for an MD-15 Import License

For an overview of the process of registering medical devices with CDSCO click here. This blog describes in detail the document requirements for the Import License.

Preparing Documentation for CDSCO

While applying for the MD-15 Import License, certain files have to be prepared as per the format provided by the CDSCO:

1. 1. 1. Plant Master File (similar to the Quality Manual) 
      2. Device Master File (similar to the Device Technical File) 
      3. Predicate Table (similar to the substantial equivalent devices described in the Clinical Evaluation Report)  

The remaining document requirements are the files that are typically available if the manufacturer has approval from a GHTF country. The table below gives the requirements based on classification where the manufacturer can leverage their existing documents when applying for the MD-15 Import license. 

Once the dossier is submitted, queries are responded to the CDSCO’s satisfaction, and approval in the MD-15 Import License is obtained, the manufacturer must maintain Post Approval Compliances of the device and manufacturing site update as required under the conditions of the Import License. This allows the manufacturer to maintain the validity of the license for perpetuity and only pay the retention fees every 5 years – making the process of license extension hassle-free. If post-approval compliances are not followed, then the manufacturer would have to do the entire registration process all over again. 

Why Choose MedEnvoy as your Import License Holder?

The role of the Importer in India requires a knowledgeable firm that has experience not only in the Medical Device Rules, 2017 but also in working with the Indian Customs. 

Selecting an independent importer as your Import License Holder gives you the freedom to:

• • Work with multiple distributors 
  • Protect sensitive information on your device technical file & Manufacturing 
  • Remain compliant post-approval to minimize supply chain disruptions 
  • Maintain your independence at minimal cost.  

There is an important point to note, which is often not regarded with importance during your initial decision-making of obtaining product registrations. Based on your product type, you may need other specific licenses: example (but not limited to): Electronic Waste Disposal License, BIS Certificate for batteries supplied with your medical products, PC & PNDT certificate for ultrasound devices, Atomic Energy Regulatory Board Certificate for X-ray and other radiation-related Products, etc.

An Independent Importer allows you to simplify your labeling requirements, manage your India inventory in a streamlined method, and provide up-to-last-mile delivery to different and deeper pockets of the Indian subcontinent. Whether you’re launching your products in India or wish to transfer the license or select / change distribution partners, by appointing MedEnvoy as your India Authorized Importer, you can take advantage of our expertise to have minimal disruption in your supply chain.

Learn More about How to Obtain an MD-15 India Import License with MedEnvoy

MedEnvoy’s regulatory experts can assist manufacturers in staying compliant with the latest requirements including how to obtain an MD-15 Import License. Please reach out should you need assistance by clicking here and for information about our regulatory experts click here.

Additional Resources

• • Challenges Selecting Distributors as India Authorized Importers
  • India Authorized Importer