Basics & Checklists for Medical Device Import application. Compiled by Rihim Pharma.
After the release of Medical Device Rules 2017, a whole new array of terminologies have evolved in the medical device industry. One of the most frequently asked question is "what to do if I'm an importer of medical devices in India?" The straight answer is - apply for the MD14 licence at CDSCO. Here are a few insights on the same.
The MD 14 Import license in CDSCO India refers to the license required for the import of medical devices that are classified as medium and high-risk under the Medical Device Rules, 2017. This license is issued by the Central Drugs Standard Control Organization (CDSCO), which is the national regulatory body responsible for regulating medical devices and drugs in India.
To obtain the MD 14 Import license, the importer must comply with the regulatory requirements outlined in the Medical Device Rules, 2017. This includes providing the necessary documentation and paying the requisite fees. The application is then reviewed by CDSCO, and if all requirements are met, the license is granted.
The MD 14 Import license is essential for the import of medical devices into India as it ensures that the devices meet the safety and quality standards set by CDSCO. It also helps to prevent the import of sub-standard or counterfeit medical devices, which can be dangerous for patients. Overall, the MD 14 Import license plays a critical role in ensuring the safety and efficacy of medical devices in India.
MD 14 Application Documents required from the Exporter or Manufacturer
# | MANDATORY DOCUMENTS |
|---|---|
1 | Free Sale Certificate/Marketing Authorisation of product from National Regulatory Authority (NRA) of the Country of Origin - Duly apostilled/notarised copy |
2 | Duly apostilled/notarized copy of Free Sale Certificate Marketing Authorization of the product from National Regulatory Authority of any of the following countries viz USA, EU, Canada, Japan, Australia. |
3 | Copy of latest inspection or audit report carried out by Notified Bodies or NRA or Competent Authority within last 3 years. |
4 | ISO 13485 Certificate (Notarised copy) |
5 | Full Quality Assurance Certificate / CE Type Examination Certificate / CE Product Quality Assurance (Notarised copy) |
6 | CE Design Certificate (Notarised copy) |
7 | Notarized Declaration of Conformity |
8 | Plant Master File from the Manufacturer as specified in Appendix 1 of Fourth Schedule of Medical Device Rules (See Rihim's Appendix 1 Form) |
9 | Device Master File as per Appendix 2 of Fourth Schedule of Medical Device Rules |
10 | Notarised copy of overseas manufacturing site OR establishment OR plant registration, by whatever name called, in the country of origin issued by the competent authority |
11 | Power of Attorney (Original) - Draft provided by Rihim, Signature, Stamp and Appostile or Attestation from Indian Embassy in the Country of Origin |
MD 14 Application Documents required from the Importer or Indian Agent
# | MANDATORY DOCUMENTS |
|---|---|
1 | Constitution details of domestic manufacturer or authorised agent (required for Class B, C and D) |
2 | Fee Challan (Guided by Rihim during submission) |
3 | Legal Form (Draft to be provided by Rihim) |
4 | Wholesale License (MD-42) OR Manufacturing License (MD-3) - Self Attested |
5 | Covering letter (Rihim will draft and share for signing) |
6 | POA + Undertaking (Rihim will draft and share for verification) |
7 | Importer Label/Secondary Label (self attested by Authorized Indian agent) |
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