Medical device import license

What is Medical device import license?

The devices that are proposed for the external and internal use for the detection, treatment, mitigation or prevention of an ailment or disorder in humans or animals that are specified by the Central Government by notification in the official gazette is called as a medical device. 

The production, sale, distribution and import of the medical devices are regulated under the provisions of the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945. According to the act all the notified medical devices are regulated in India.

The various regulatory authorities that governs the import of medical devices are Drugs Controller General (India), Ministry of Health and Family Welfare, Directorate General of Health Services, Central Drugs Standard Control Organization (CSDSCO), FDA Bhavan etc.

A person or a firm possessing the wholesale and manufacturing license under Drugs and Cosmetics Act, 1940 and Rules 1945 can apply for the medical device import license in India. For the import of medical device, the manufacturing site and the products are required to be registered with Indian drug regulatory agency.

Types of medical device import licenses issued in India

  • The classification of medical devices are done by Central Drugs Standard Control Organization (CDSCO) according to the risk. The risk is analyzed based on the intended use of the device and the purpose. According to this the medical devices are classified as;

    • Class A
    • Class B
    • Class C
    • Class D

Class A

The devices under Class A are belong to low risk category. The licensing authority for the import of Class A medical devices is the Drugs Controller General of India (DCGI). The devices include adsorbent cotton wools, alcohol swabs, umbilical occlusion devices, surgical dressings, nasopharyngeal catheter etc. The stipulated timeline for processing the application is up to 9 months from the date of application.

Class B

The devices under Class B are belong to low moderate risk category. The licensing authority for the import of Class B medical devices is the Drugs Controller General of India (DCGI). The devices include disinfectants, thermometer, BP monitoring device, rectal balloon, medical injectors, blood collecting needle, bone caps etc. The stipulated timeline for processing the application is up to 9 months from the date of application.

Class C

The devices under Class C are belong to moderate high risk category. The licensing authority for the import of Class C medical devices is the Drugs Controller General of India (DCGI). The devices include hemodialysis catheter, implants, ablation devices, bone cements, contraceptives, internal prosthetic replacements etc. The stipulated timeline for processing the application is up to 9 months from the date of application.

Class D

The devices under Class D belong to high risk category. The licensing authority for the import of Class D medical devices is the Drugs Controller General of India (DCGI). The devices include heart valves, angiographic guide wires, cardiac catheterization kits, cardio vascular catheters, eye sphere implants, retinal implants etc. The stipulated timeline for processing the application is up to 9 months from the date of application.

Forms required for Medical Device Import License?

Form 40: Form 40 is the application form for the registration certificate for medical device. This is required if the products to be imported come under the notified device category.

Form 41: The registration certificate for the medical device is obtained in Form 41. The certificate is valid for 3 years.

Form 8: After the foreign manufacturer gets the registration certificate in Form 41, then the distributor must apply for the import license. Form 8 is the application form for the import license.

Form 10: The import license is obtained in Form 10. The license permit the import of medical devices in to the country.

Form 12: Form 12 is the application form for the Test License for import. 

Form 11: The Test license for import is obtained in Form 11. This is required for the import of small quantities of medical devices and drugs for analysis, examination and testing. Those products imported using this license can be used only for testing purposes and not for commercial activities.

Form 44: This is the application form to obtain the clinical trial permission.

Documents required for Medical Device Import License?

Documents required for Medical device import License:

  • Covering letter (It should clearly state the intent of the application, the list of documents that are submitted along with any other relevant information. This should be duly signed and stamped by the authorized signatory indicating the name and designation of the authorized signatory along with details like Fax No., Email id etc.)
  • Authorization letter in original issued by the director or company secretary or partner of the Indian agent firm revealing the name and designation of the person authorized to sign legal documents like Form 40, Power of attorney etc. on behalf of the firm should be submitted at the time of submission of the application for registration. Duly self-attested copies of the authorization letter may be submitted at the time of submission of subsequent applications.
  • Duly filled form 40 as per the format specified in the Drugs and Cosmetics Rules signed and stamped by the Indian agent along with name and designation.
  • Requisite fee.
  • Power of attorney authenticated either in India before a first class magistrate or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian embassy of the said country. Apostille power of attorney from Hague convention member countries is also acceptable.
  • Free sale certificate (Duly notarized or attested by Indian Embassy in the country of origin)
  • ISO 13485 certificate in respect of the manufacturing site. (Duly notarized or attested by Indian Embassy in the country of origin)
  • CE full quality assurance certificate in respect of the legal and actual manufacturing sites if applicable. (Duly notarized or attested by Indian Embassy in the country of origin)
  • CE design certificate if applicable. (Duly notarized or attested by Indian Embassy in the country of origin)
  • Declaration of conformity (Duly notarized or attested by Indian Embassy in the country of origin)
  • Product inserts (English version or authenticated copy) mentioning specificity and sensitivity wherever applicable and published articles (if any) for each to be imported.
  • A duly filled Schedule D (I) along with the undertaking as per the format prescribed in the Drugs and Cosmetics Act and Rules signed and stamped by the manufacturer specifying the name and designation of the authorized signatory.
  • Plant master file.
  • A duly filled Schedule D (II) as per the format prescribed in the Drugs and Cosmetics Act and Rules signed and stamped by the manufacturer specifying the name and designation of the authorized signatory.
  • Device master file.
  • Specimen batch test report for at least three consecutive batches indicating specification of each testing parameters from manufacturer.
  • The detailed test report of all the components used or packed.
  • Soft copy of the dossier summary sheet in word format.

What is the procedure for applying for Medical Device Import License?

  • Identify if the product requires registration. Only the medical devices notified under Drugs and Cosmetics Act, 1940 and rules, 1945 are required to be registered.
  • Appoint an authorized Indian agent. The agent will act as a link between you and the CDSCO’s medical devices division. The agent should possess a wholesale drug license in form 20B and 21B.
  • Submit the required documents of registration.
  • Obtain the registration certificate in Form 41. The manufacturer will be the holder of the registration certificate. The certificate is valid for three years.
  • Apply for the import license in form 8.
  • Obtain the Medical Device Import license in Form 10.

What if you violate the law?

The violation of MDR including failure to get the registration or license may result in criminal prosecution. This may lead to imprisonment and fine. The medical devices which is sold without registration or license is liable to confiscation.

Conclusion

For being the importer of notified medical devices in India, one must possess the Medical Device Import License. It is required for them to strictly follow the rules and regulations of the act. Failing to comply with these may lead to punishable offenses under the act.

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