IVD Performance Evaluation Report in India: Three Batch Requirement

1. Key takeaways

India requires a performance evaluation report (PER) for Class B, C, and D IVDs, and the report must cover three independent batches, produced from three different lots of critical raw materials such as antigens or antibodies. Testing may be carried out at the Central Medical Device Testing Laboratory, at a laboratory registered with the CLA, or at a government laboratory, national-level hospital, or NABL-accredited laboratory meeting the specifications in CLA guidance.

• Three batches means three independent production runs, each traceable to a different lot of critical raw material.
• The requirement is a production planning constraint, not merely a documentation exercise.
• The range of acceptable testing laboratories is wider than the central laboratory alone, but each alternative must follow CLA specifications.
• Sample size must be statistically significant under a protocol designed and approved by the central laboratory.
• For HIV, HBsAg, and HCV, the CDSCO states explicit sensitivity and specificity thresholds.

2. Legal basis

The requirements are set out in the CDSCO’s IVD frequently asked questions, which function as detailed operational guidance. The table below sets out each item, the question in which it appears, and its content.

3. Expert insights

Insight one: three batches from three raw material lots is a production planning problem, not a documentation problem. It requires the manufacturer to arrange, before submitting the application, that three different lots of critical raw materials are put into production and sent for testing. The rule pushes the starting point of an IVD project back into the manufacturing function, and it is the first scheduling constraint on every IVD project. A plan that begins with dossier writing will inevitably discover this constraint late.

Insight two: the CDSCO even specifies the acceptance criteria. HIV and HBsAg rapid tests require 100 percent sensitivity, HCV rapid tests require at least 99 percent, and specificity is uniformly at least 98 percent. These are hard thresholds, and failure means rejection. Publishing performance thresholds inside an FAQ is unusual in other markets, and it has one practical benefit: the acceptance bar is knowable in advance rather than negotiated during review.

Insight three: the PER report format is also standardised. Question 73 lists, item by item, the fields that the report must contain. Writing to this list can remove one full round of correction. It also gives the testing laboratory a specification to work against, which is more reliable than asking the laboratory to produce a report in its own house format and then translating it afterwards.

Insight four: pre-import samples can enter under a test licence. The three batches of samples may be imported under a test licence through Form MD-16 and MD-17, at a fee of USD 100 for Class A, B, C, and D alike, for non-commercial purposes. This is the mechanism that allows testing in India without a full import licence, and it should be planned as a separate logistics workstream with its own documentation.

4. Practical recommendations

The first action GRZAN takes on an IVD project is production scheduling, not document writing. Together with the client’s manufacturing department, we confirm the arrival and production dates of the three lots of critical raw materials, work backwards to the testing and report issuance dates, and then backwards again to the submission date. We also draft the report template according to the field list in question 73 and hand it to the laboratory before testing begins — getting the laboratory to issue the report in the Indian format is far more reliable than translating and reorganising it afterwards.

• Schedule three independent batches against three different critical raw material lots before any dossier work starts.
• Confirm the chosen laboratory falls within the accepted categories and follows CLA specifications.
• Provide the laboratory with the question 73 field list as a report template in advance.
• Verify sensitivity and specificity against the question 70 thresholds before shipping samples.
• Plan the MD-16 to MD-17 test licence route for sample import and budget the USD 100 fee.

5. Verification checklist

• □ Three independent batches have been scheduled, using three different lots of critical raw materials
• □ The testing laboratory is the Central Medical Device Testing Laboratory, a CLA-registered laboratory, or a government or NABL-accredited laboratory
• □ The report has been drafted according to the question 73 field list
• □ Sensitivity and specificity for HIV, HBsAg, and HCV products meet the question 70 criteria
• □ Sample import has been arranged under the MD-16 to MD-17 test licence at USD 100

Regulatory information verified as of 27 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com