Q.01

How do I find a registered medical device testing laboratory in India?

To find a registered lab, use CDSCO's list. Labs registered under Chapter X of the Medical Devices Rules, 2017 hold a Form MD-40 certificate, and CDSCO publishes them as "Approved Medical Device Testing Laboratory" on its Medical Devices Online portal (cdscomdonline.gov.in/NewMedDev/ListOfTestingLaboratory). The link is on the CDSCO Medical Device & Diagnostics page. CDSCO's FAQ says manufacturers may send devices for test or evaluation to a lab (MDTL) registered with CDSCO under MDR-2017, and that the published list "is dynamic in nature" [1].

How to use the list

  • The portal page opens under the heading "List Of Testing Laboratories". The lab entries did not load when I opened it, so I can't tell you which columns or filters it has. You'll need to open it in a browser.
  • Each registration covers specific devices, not all testing. The MD-40 certificate has an annexure listing the generic name and risk class of each device the lab is registered for [2]. Check that your device and its class are on it.
  • The same CDSCO page also links an older PDF, "List of the Certified Medical Device Testing Laboratory under MDR, 2017" (dated 17 Aug 2022). That PDF returned "not found" when I tried it, so use the live portal list instead.

What "registered" means under MDR 2017 (Chapter X)

  • Application: the lab applies to the Central Licensing Authority on the government online portal in Form MD-39, with the fee in the Second Schedule. It must include a valid accreditation certificate from the National Accreditation Body for Testing and Calibration Laboratories (NABL) or another body the Central Government notifies (Rule 81) [3][4]. CDSCO's FAQ adds that the lab "shall be NABL accredited" and conform to ISO/IEC 17025 [5].
  • Grant: a Medical Device Officer inspects the premises first. The Central Licensing Authority then "may grant registration in Form MD-40" or reject the application, within 45 days of the application (Rule 83) [4].
  • Validity: the registration lasts indefinitely unless suspended or cancelled. The lab must pay a retention fee every five years. If it hasn't paid within six months of the due date, the registration is deemed cancelled (Rule 84) [4]. A registration can be suspended or cancelled wholly or partly, for particular devices (Rule 86) [6]. So a lab you find in an old copy may no longer be valid.

A separate category: Central medical device testing laboratories under Rule 19 are set up or designated by Central Government notification, for testing, as appellate laboratories, or other assigned work. A lab cannot be designated unless NABL has accredited it [7]. These are not the same as the MD-40 labs that test on a manufacturer's behalf.

Approach: I searched the Medical Devices Rules, 2017 (the original 2017 Gazette text, without later amendments) and CDSCO's medical device and IVD FAQs, then checked the CDSCO website for the published list. The datasets I can search don't hold the list of registered labs itself, so the portal is the place to look.

Q.02

What tests does my device need before licensing?

There is no single list of tests every device must pass. Under India's Medical Devices Rules, 2017 (MDR 2017), the testing you need depends on three things: whether the product is an in-vitro diagnostic (IVD) or another medical device, its risk class, and whether a predicate device is already approved in India. Every device has to meet a product standard and come with verification and validation data. Class B, C and D IVDs also need a performance evaluation report from an Indian testing lab. A device with no predicate needs clinical investigation data, unless a waiver applies.

1. Every device: meet a standard (Rule 7) The device "shall conform" to Bureau of Indian Standards (BIS) standards or standards notified by the Health Ministry. If none exists, it must meet ISO, IEC or pharmacopoeial standards. If none of those exists either, it must meet validated manufacturer's standards [8]. Manufacturers "shall follow" the Ministry's essential principles of safety and performance (Rule 6) [8]. You show conformity in an Essential Principles checklist. It can rely on Rule 7 standards, in-house test methods, pre-clinical and clinical evidence, or comparison with a similar device already on the market [9].

2. Non-IVD devices: verification and validation in the Device Master File (Fourth Schedule, Appendix II, section 7) These items apply "wherever applicable" or "where applicable":

  • General verification and validation: engineering tests, laboratory tests, simulated-use testing, animal feasibility tests, and published literature. The dossier also needs device design validation data [9].
  • Biocompatibility:
    • ISO 10993 "should be followed" for invasive devices.
    • At a minimum, test samples from the finished device, sterilised if it is supplied sterile.
    • If you did no new testing, give a rationale [10].
  • Sterile devices: sterilisation validation, covering sterilizer qualification, bioburden, pyrogen testing, sterilant residues (if applicable) and packaging validation [10]. Also evidence of ongoing revalidation [11].
  • Other data where relevant:
    • software verification and validation
    • animal studies, which must be GLP-compliant
    • stability data: real-time ageing, or accelerated data for a provisional shelf life, with real-time testing started straight away
    • clinical evidence, or a substantial-equivalence evaluation if a predicate exists
    • batch release certificates and certificates of analysis for at least 3 consecutive batches [11]

3. IVDs: performance evaluation by an Indian lab

  • For a Class B, C or D licence, the IVD dossier includes "a copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83" [12]. These are the MD-40 labs from your previous question.
  • Acceptance criteria (CDSCO IVD FAQ):
    • HIV, HBsAg and HCV kits: 100% sensitivity and ≥98% specificity. The exception is rapid HCV kits, which need ≥99% sensitivity.
    • Sample size must be statistically significant under the testing lab's approved protocol.
    • Other Class B and C kits must meet the performance they claim in the IFU [13].
  • New IVDs: for Class B, C and D, clinical performance evaluation "has to be conducted in India", whatever their approval status in the EU, UK, US, Australia, Canada or Japan. For Class A it may not be needed unless the Central Licensing Authority (CLA) asks for it [13][14].

4. No predicate device: clinical investigation (Rules 51 and 63)

  • Data required: design analysis (mechanical and electrical tests, reliability tests, software validation, performance and in vitro tests), biocompatibility, risk management, animal performance studies, and pilot or pivotal clinical investigation data [15]. You need prior CLA permission to run the investigation [16].
  • When the CLA can relax this (Rule 63):
    • Class A clinical data "may not be required".
    • Data may be abbreviated, deferred or omitted for life-threatening or serious diseases, for emergencies, or where no therapy exists.
    • Clinical results may not be required if the device is approved in the UK, USA, Australia, Canada or Japan and has been marketed there for at least two years, with conditions [17].
  • Devices claiming substantial equivalence: if they require clinical investigation, they "shall not be marketed" until the CLA approves them [18].

5. Making samples to test: the test licence To manufacture small quantities for testing, evaluation or clinical investigation, apply in Form MD-12. The CLA grants it in Form MD-13 within 30 days, and it is valid for three years (Rule 31) [19]. One test licence can cover several testing sites [20]. Custom-made devices need no test licence [21]. In the Class B, C and D dossier list, the test licence appears as "(for domestic manufacturers only), if any" [12].

If you tell me the device, its class and whether a predicate is approved in India, I can narrow this to your exact dossier and check CDSCO's risk-classification lists.

Approach: I searched the Medical Devices Rules, 2017 (Rules 6, 7, 31, 51, 63 and 64, and the Fourth Schedule) and CDSCO's medical device and IVD FAQs. The Rules text I can search is the original 2017 Gazette version without later amendments, so any later changes to these requirements are not reflected here.

Q.03