Chapter V of the Medical Device Rules 2017[1] covers rules and regulations for importing Medical Devices into India. It discusses the conditions and rules for grant of Import licenses for multiple purposes. It allows Import of Medical Device for Personal Usein small quantity, which are otherwise prohibited for import as per section 10 of The Drugs and Cosmetics act, 1940. Form MD-20 is submitted as the application for obtaining permission for the same, and Form MD-21 is obtained from the Central Licensing Authority as permission for the grant of license for import of medical devices for personal use.
Application for permission to import a small quantity of medical devices for personal use
Section 43 of the Medical Device Rules 2017 lays down conditions for the import medical devices for personal use. Medical devices which are prohibited under section 10 or Drugs and Cosmetics Act 1940 may be allowed for import in small quantities for personal use under the following conditions-
- The medical device should be exclusively for the passenger’s personal use and must be carried as a part of the personal baggage of the passenger.
- According to the customs authorities’ directions, the medical device shall be declared as the personal baggage of the passenger.
- The quantity of medical device which has to be imported shall not exceed the quantity specified by the registered medical practitioner.
- A registered medical practitioner should prescribe the medical device.
- The imported medical device should include an invoice or a statement that specifies the product’s name and quantity.
If there is a small quantity of Medical device which is prohibited for import under sec 10 of the Drugs & Cosmetics Act 1940, and it is not a part of bona fide personal baggage of the importer, then there is a confirmation required stating that the device is for bona fide personal use, in an application through Form MD-20. The confirmation of the bona fide personal use of a medical device shall be accompanied by relevant documents and a prescription made by a registered medical practitioner. The application is submitted to the Central Licensing Authority.
If the Central Licensing Authority is satisfied with the application form MD-20 and all the attached documents and information, It may grant permission to the application through form MD-21. In case of any rejection, the CLA must record the reasons for doing so, in writing, within 7 days from the date of application.
Application Form required for the Import of Medical Device for Personal Use
| Application Form | Approval Form | Risk/Class | Licensing Authority |
| Form MD-20 is used an Application for the permission for Import of Medical Device for Personal Use | Form MD-21 is given by the licensing authority as a permission for Import of Medical Device for Personal Use | A,B,C,D | CDSCO |
Required documents for Import of Medical Device for Personal Use
Following are some vital documents required for Import of Medical Device for Personal Use:
- Authorisation letter from a patient
- Patient ID proof
- ID proof of the person collecting the shipment
- Name and Address of the manufacturing site
- Details of the Medical Devices which has to be imported
- Name and quantity of the medical device which has to be imported
- A written prescription along with complete information from the recommending doctor
Conditions applicable for Medical Device Imported for personal use
As per section 43(4) of the Medical Device Rules 2017, the medical device for Import of Medical Device for Personal Use is subject to the following conditions-
- If the Customs Authorities direct, the medical devices shall be declared to them.
- The shipment of a medical device shall include details of the name and quantity of the medical device in a statement or Invoice.
Prohibition of Import on Medical Devices and Drugs
Section 10 of the Drugs and Cosmetics Act 1940 states the list of products prohibited for import.
- Any Drug or Cosmetic that is not of standard quality.
- Any misbranded / adulterated drug or spurious cosmetic.
- Any Drug or cosmetic that requires a license for import, and if imported, it should comply with the license of the same.
- Any patent or proprietary medicine is prohibited unless there is a detailed description of the quantity and list of true formulas and active ingredients used.
- Any drug that claims to cure or mitigate any disease or ailment or to give any effect to the patient through any statement, design or related device.
- Any cosmetic containing any ingredient that is unsafe or harmful for use as per the directions provided.
- Any drug or cosmetic which is prohibited for import in accordance with the rule of the act.
Some exemptions exist for the prohibition of import of drugs and cosmetics according to the act. These are-
- A small quantity of drugs to be imported for examination, test or analysis for personal use shall be exempted from the prohibition.
- If the drug or cosmetic is not of standard quality, the central government may consult the board and may permit the import through a notification in the official gazette.
Conclusion
India has recently become more dependable on the Import of Medical devices. The increase in import of medical devices has been noted for about Rs 63,200 crore in the year 2021-22, which has increased by 41% from Rs 44,708 crore in the FY 2021, as per the Association of Indian Medical Device Industry. The Indian Medical Device Market is estimated to be Rs 87,752 crore, with foreign suppliers contributing about 70% of the Market. Due to the larger market size for the Import of Medical Devices, many rules govern a single procedure. If not guided by a relevant source, the Import licensing process may become over-complicated, and a single missed document may cause multiple losses at once or even cancellation of the license. Thus, it is always recommended to take the aid of a legal expert or a guide to go through the entire process at ease, thus saving time and money.
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