The Medical Device Rules, 2017 went into effect the beginning of this year, January 2018. Though the Act comprehensively covers “medical devices”, it failed to providing details for In Vitro Diagnostic devices (IVDs), digital health products, and software products. Recently, the Central Drugs Standards Control Organization (CDSCO) released a document in the form of Questions and Answers (frequently asked questions) to provide much needed clarity for IVDs.
To learn more about the medical device regulations, click here.
Here are answers to some of the most common questions.
Q: How are IVDs defined?
A: IVDs are substances intended to be used outside human or animal bodies for the
diagnosis of any disease or disorder in human beings or animals.
Q: Which agency will regulate IVDs in India?
A: The Drugs Controller General, India will regulate the importation process while the Medical Devices & Diagnostics Division of the CDSCO will regulate the review of IVDs .
Q: How are IVDs classified?
A: A risk-based classification as follows
- Class A (low risk)
- Class B (low moderate risk)
- Class C (moderate high risk)
- Class D (high risk)
Q: Is software covered by this regulation?
A: No, software is beyond the scope of the regulation.
Q: Which laboratory can be used for IVD testing?
A: The National Institute of Biologicals based in Noida, Uttar Pradesh.
Q: Can multiple distributors apply to import the same product?
A: Yes, as long as they each submit submit separate applications.
Q: Will overseas manufacturing plants of IVD be inspected prior to approval?
A: Not compulsorily, but CDSCO can use its discretion and choose to do so.
Q: How long will import licenses be valid?
A: In perpetuity, provided the license retention is paid every 5 years.
Q: What are the import license fees?
A:
| Risk Class | Product Fee (USD) | Manufacturing Site Fee (USD) |
| A | 10 | 1000 |
| B | 10 | 1000 |
| C | 500 | 3000 |
| D | 500 | 3000 |
Q: Which agencies will need to approve the import of IVD reagents and kits?
A:
- No objection certificate from the Director General, Indian Council of Medical Research, or from an accredited lab or government recognized agency.
- No objection certificate from the Bhabha Atomic Research Centre (BARC), in case of Radio ImmunoAssay IVD kits.
Q: Can marketing authorizations from the US, EU, Canada, Japan or Australia be used waive clinical evaluations?
A: No, clinical evaluations must be conducted for all new IVDs in India.
Q: Should both legal and actual manufacturers be listed in Free Sales Certificates used to import IVDs?
A: Yes.
Q: Which dates must be printed on IVD labels?
A: Date of manufacture and date of expiry must both be printed on IVDs.
