Hi cool1984, hi to all others who thinking about IVD software (or SaMD) for the indian market.
Here is what I figured out:
Key policies:
•DCA (Drug and Cosmetics Act)
•IMDR (Indian Medical Device Rule, IMDR) (primary base regultory framework)
•(since 2020): all IVDs and medical devices (not only the listed ones) fell under IMDR
•Analyzers, Instruments and Software used with IVDs are covered in the scope of Medical Devices Rules, 2017
Classification:
- https://cdsco.gov.in/opencms/export...documents/medical-device/Classificationg1.pdf
- Here: Part (B) “List of In Vitro Diagnostics Medical Devices under provisions of sub-rule (2) rule 4 of the medical devices rules 2017“
- 1st schedule, Part II:
- (c) Software, which drives a device or influences the use of a device, falls automatically in the same class.
- (d) Standalone software, which are not incorporated into the medical device itself and provide an analysis based on the results from the analyser, shall be classified in to the same category that of the in vitro diagnostic medical device where it controls or influences the intended output of a separate in vitro diagnostic medical device.
- Classification is done via paragraph to in 1st schedule part II
Software documentation as per IEC 62304, because:
- IMDR, 4th schedule, Part III, Appendix III:
- (i) a description of any software to be used with the in vitro diagnostic medical device;
- (j) a description or complete list of the various configurations/variants […] that will be made available;
- IMDR, 4th schedule, Part IV, Appendix III:
- (b) Data to be submitted along with the application (for new in vitro diagnostic medical devices):- (iii) product validation and software validation relating to the function of the device (if any);
- BIS (Bureau of Indian standards) harmonized: [1]
- Guidance [2] document on essential principles for safety and performance
- 6.4.2 IVD medical devices should designed and manufactured in such a way as to remove or reduce as far as reasonably practicable and appropriate: (v) the risk associated with the possible negative interaction between software and the environment within which it operates and interacts; (Comment: Risk analysis)
- 6.7.1 For IVD medical devices which incorporate software or for standalone software that are IVD medical devices in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, verification and validation
[1]
https://cdsco.gov.in/opencms/opencm...ts/download_file_division.jsp?num_id=NzYzNw==
[2]
https://cdsco.gov.in/opencms/opencm...ements/download_file_division.jsp?num_id=NDU3
Software tool validation, because
- IEC 62304 (if safety class B or C)
- But: safety class A includes documentation of testing tools
- IMDR, 5th schedule (QMS for medical devices and in vitro diagnostic medical devices)
- 6.3 Infrastructure: (b) process equipment (both hardware and software)
- 7.3.6 Design and development validation: Design validation shall include software validation and risk analysis
- 7.5.2 Validation of processes for production and service provision: validation of the application of computer software
Summary (comply with):
- Indian Medical Device Regulation
- S.O.648(E) of the Medical Device Regulation
- ISO 13485
- ISO 14971
- IEC 62304
- IEC 81001-5-1
- IEC 62366-1
- In September 2021, the CDSCO brought SaMD under MDR’s risk based classification:
- Class A: All SaMD that does not directly interpret or interfere with patient clinical data come under low risk, Class A classification
- Class B: All SaMD that provides the patient with real-time information of the patient’s parameters but are not used to provide clinical diagnosis come under Class B.
- Class C: All SaMD that helps in diagnosis of disease conditions as well as direct analysis of patient’s physiological activity, come under Class C.
- Class D: CDSCO has not identified any SaMD posing high risk to patients, as of yet.
- The SaMDs, once classifies shall follow the same registration process as regular medical devices in India.
