Government Authority (CDSCO)
The Indian Medical Device Regulation, established by the CDSCO, must be followed by all medical devices imported into India. In addition to setting drug standards, controlling the quality of imported medical devices, and coordinating the work of state drug control organizations, the CDSCO oversees the approval and regulation of all medical devices and clinical trials conducted in the nation. According to the updated CDSCO guidelines, Class C and D medical device imports may be suspended or canceled if an importer misses the deadline for obtaining a mandatory import license.
Medical Device Regulations in India which a manufacturer or importer needs to keep an eye on:
- The 1940 Drugs and Cosmetics Act and the 1945 Drugs and Cosmetics Rules
- Medical Devices Rules, 2017
- Medical Devices (Amendment) Rules, 2020
Status of medical devices
Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257), providing an Import License grace period to all Non-Regulatory Class C and D medical devices. This came one day before the October 1 deadline outlined in G.S.R. 102 (E), where all Class C and D medical devices were required to have an Import License before importation into India. This Import License grace period ensured that Non-Regulatory Class C and D medical devices, which were currently Registered and had pending Import License applications as of September 30, 2022, could still be imported and marketed for another six months while their applications were reviewed.
Class C medical device
Medical devices classified as class C are considered moderately high risk. CDSCO requires a manufacturer’s license from any business that plans to manufacture these medical devices for retail or distribution. Examples are Blood bags, syringes, etc.
Class D medical device
Medical devices classified as class D are considered High risk. CDSCO requires a manufacturer’s license from any business that plans to manufacture or import these medical devices for retail or distribution. Examples are Spinal needle bioimpedance, etc.
For the import license, the authorized agent needs to submit the following documents:
- 1. Cover letter
- 2. Power of attorney
- 3. Wholesale license
- 4. Free sale certificate from country of origin
- 5. Free sale certificate from any country, namely the U.S.A., Australia, Canada, Japan, U.K., and European Union countries.
- 6. Inspection or audit report
- 7. Certificates (ISO, full quality certificate, C.E. design certificate, Declaration of conformity)
- 8. Plant master file (as per appendix I of M.D.R., 2017)
- 9. Device master file (as per appendix II of M.D.R., 2017)
- 10. Label and I.F.U.
- 11. Establishment certificate
- 12. Constitution details of the authorized Indian agent.
Forms for Class C and D notified medical devices:
| FORMS | DESCRIPTION |
|---|---|
| Form MD-14 | Application to import. |
| Form MD-15 | Permission to import. |
Fee structure:
Import license for Class C medical device
| Subject | Fees (in rupees) INR |
|---|---|
| (a) one site; | $3000 |
| (b) each distinct medical device | $1500 |
Import license for Class D medical device
| Subject | Fees (in rupees) INR |
|---|---|
| (a) one site; | $3000 |
| (b) each distinct medical device | $1500 |
Import license retention fee for
| Subject | Fees (in rupees) INR |
|---|---|
| (a) one overseas site manufacturing Class C medical devices. | $3000 |
| (b) each distinct medical device of Class C medical device | $1500 |
| (c) one overseas site manufacturing Class C medical devices; | $3000 |
Import license retention fee for
| Subject | Fees (in rupees) INR |
|---|---|
| (a) one overseas site manufacturing Class D medical devices. | $3000 |
| (b) each distinct medical device of Class D medical device | $1500 |
| (c) one overseas site manufacturing Class D medical devices; | $3000 |
| Fee for import of investigational medical devices by government hospitals or statutory medical institutions to treat patients of each distinct medical device. | 500 |
CDSCO Import License Registration for Medical Devices:
Applicant Registration:
The importer or foreign manufacturer must have an active CDSCO online registration portal account for the applicant to register. An authorized agent or distributor must possess a registration certificate to sell medical devices in India. They must also apply for a CDSCO import license using Form MD-14 to the Central Licensing Authority via a designated online portal of the Ministry of Health and Family Welfare in the Central Government.
- Online submission of a form.
- Delivery of the necessary document.
- Permission from cdsco.
- If an application is denied, CDSCO will notify the applicant of the decision and, if required, allow them to reapply.
Medical Device Import License Application:
An import license application must be submitted to import medical devices for use in commerce.
- Submission of an online form containing the required information, such as the device’s classification, brand name, intended use, and product description.
- Upload the necessary paperwork, such as regulatory certificates (European C.E., free sale certificates, ISO 13485, plant master files, device master files, etc.)
- By Indian CDSCO regulatory norms, fees are charged by CDSCO based on the classification of the product.
- An application number will be generated after all documents and a copy of the fee challan are successfully submitted.
The CDSCO Review:
- In addition to reviewing the application, CDSCO will verify the uploaded documents. If any questions are found, they will raise a query.
- We are submitting updated documentation or pertinent justification via the portal.
Approval of License
The license will be granted if the justification and documentation follow CDSCO regulations.
How to Get a Medical Device Manufacturing License from CDSCO Step-by-Step:
Step 1: Classifying the medical device – By CDSCO regulatory guidelines
Classifying medical devices is the first step in the CDSCO registration process. The next step is to get the application file ready after proper classification. All relevant details regarding the medication or medical device, such as its composition, formulation, manufacturing method, required regulatory certificates and intended use, should be included in the application file. All pertinent clinical trial data should be included in the application if available.
Step 2: Using the CDSCO Portal Online to submit the application
After the application is ready, it must be uploaded online to the CDSCO portal along with the necessary CDSCO fees. After reviewing the application, the CDSCO may, if needed, ask for more details or clarification.
Step 3: Examining CDSCO
The CDSCO will examine the application upon receipt and ascertain the safety and efficacy of the medication or medical device for its intended purpose. To conduct an evaluation, it may be necessary to review all pertinent data, visit the site, and confer with subject-matter experts.
Step 4: Acceptance or Disapproval
The CDSCO may approve the medication or medical device for sale and distribution in India based on the evaluation. Alternatively, if it determines that the medication or medical device does not fulfill the necessary safety and efficacy standards, it may reject the application.
Inspection of Manufacturing Facility:
The CDSCO will inspect your manufacturing facility after reviewing your application. Whether your facility complies with CDSCO regulations will be determined by the inspection.
Validity –
Import license – Five years.
The regulatory framework for medical devices in India, overseen by the Central Drug Standard Control Organisation (CDSCO), is crucial in ensuring low-risk medical devices’ quality, safety, and proper functioning. Classifying devices into risk categories allows for a tailored regulatory approach, ensuring that the regulatory burden is commensurate with the potential risks associated with these devices. This benefits manufacturers by expediting market entry and provides continued oversight to safeguard public health.