- According to the Association of Indian Medical Device Industry (AiMeD) report, in the year 2021-22, there was an increase of 41% to ₹63,200 crores from ₹44,708 crores in 2020-21 in the import of medical devices in India. India imports medical devices from China, the US, Germany, Singapore, and the Netherlands, as per AiMeD analysis. In India, CDSCO (Central Drug Standard Control Organization), DCGI (Drug Controller General of India), and Drugs and Cosmetics Rules and Acts regulate the import of medical devices to maintain the quality, safety, and efficiency of imported medical devices.
- CDSCO uses the different Forms for the application and approval processes; below in the table, the information related to forms is shared:
Application form | Description | Class | Fees | Licensing Authority |
Form MD-14 | Application for issue of import license to import medical device | A, B, C D. | For class A $1000 $50 per product. For class B: $2000 $1000 per product. For class C D: $3000 $1500 per product. | CDSCO |
Form MD-15 | Permission Licence to Import Medical Device | |||
Form MD-16: | Application for License to import for purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training | A, B, C D. | $100 For all classes | |
Form MD-17 | License to Import Medical Devices for Clinical Investigations or Test or Evaluation or Demonstration or Training | |||
Form MD-18: | License to import investigational medical devices for a government hospital or statutory medical institution for the treatment of patients | A, B, C D. | Rs. 500 For all classes | |
Form MD-19 | Permission to import investigational medical devices by a government hospital or statutory medical institution for the treatment of patients | |||
Form MD- 20 | Application for permission to import a small number of medical devices for personal use | A, B, C D. | ||
Form MD-21 | Permission tothe import of small quantity of medical devices for personal use |
Blog Content -
- Things to keep in mind while applying import license are:If there is any change in the documents submitted during the time of application, then CLA should be informed before the grant of permission. And, If medical devices are imported from countries other than those mentioned in sub-rule (3) of medical device rule,2017, then there two conditions need to be fulfilled:Class A and B license is granted after evaluating the safety and performance. And, Class C and D license is granted after evaluating safety and effectiveness.Who can apply for an import license in India – For a foreign manufacturer, an authorized agent must be appointed who has a manufacturing license or wholesale license as per the guidelines given by the CDSCO. Class A and B Non-notified medical devices must have an import license by 1st October 2022, while class C and D Non-notified medical devices will have until 1st October 2023
Why do you require an import license for the medical device:
- Safety -When a medical device applies for an import license in India, it must submit many technical documents to prove its safe use. The records include fee challan and clinical evaluation documents proving that the devices have been tested and are okay to use on the intended population. An import license proves that the device has a high benefit-risk ratio and can fulfil the intended use.
2. Efficiency–When a medical device gets a green signal to get imported is proof that the device is efficient from the already present device.
3. Quality–Before any medical device gets the import license and permission to import, the regulatory authority makes sure that the medical device has good qualityand has proper certificates to ensure that the device being imported has good quality.
4. Audit compliance – The import license is issued only after the audit of the manufacturing site, ensuring all the safety methodsand all the manufacturing details have been followed, indicating that the device was safe.
5. Opportunity for a foreign manufacturer – The import license allows the foreign manufacturer to Sell their product in the Indian market
6. Fulfilment of high demands–Import license allows importers to sell medical devices from other countries and helps to meet the heavy demand for medical devices in India.
7. Traceability– When a medical device is imported and used, it becomes difficult to trace back in case of any complaints. The import license gives the medical device a unique number, so traceability becomes easy in case of post-market complaints.
Summary –
In the past few years, India has emerged as one of the biggest importers of medical devices.CDSCO, India's regulatory authority, grants permission to import medical devices through Form MD-15, as per the Medical Device Rule,2017. It is compulsory for the manufacturing site and medical devices to be registered on the CDSCO portal.To obtain the import license, one must fill the Form MD-14 and appoint an authorized agent. There are different timelines set for medical devices class A, B, C, and D to obtain import licenses and market their products in India, failing to comply will lead to heavy penalties and fines.
