Testing Standard Requirements around the World

Testing Standard Requirements around the World

Medical device testing standard- an overview

Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country.

Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards.

Medical device testing applies to all medical devices, in-vitro diagnostic devices, combinational products, and active implantable devices. Some common testing of medical devices is given below:

  • Electrical safety tests
  • Functional safety tests
  • Performance tests
  • Electromagnetic compatibility (EMC) tests
  • Electromagnetic Interference (EMI) tests
  • Immunity Tests
  • Biocompatibility tests
  • Chemical testing
  • Cybersecurity tests (applicable to SaMDs or software that store data)
  • Storage and Transport
  • Ingress Protection

Medical device testing is crucial as the device intended for patient use must be safe. The tests a medical device must undergo depend on the device’s type. To explain further, medical equipment like a ventilator must undergo an electrical safety test.

At the same time, a device such as a cannula requires appropriate biocompatibility tests. Hence, the choice for a practical device test is taken with the help of the medical device’s intended use.

The testing procedure should be logical and must begin with a risk analysis. After identifying the failure mechanisms and hazards associated with a device, testing strategies and processes can be devised to quantify the size of these risks.

As a result, the purpose of a test method and procedure is to offer evidence that the hazards connected with a device are insignificant or, at the very least, acceptable when weighed against the benefits received from its use.

Types of medical device testing

Medical device testing is broadly categorized into physical, chemical/biological and cybersecurity testing. Physical testing involves the tests such as electrical testing, MRI safety, functional safety tests and EMC tests.

IEC 60601 series is a widely accepted technical standard for the safety and performance of electrical equipment. EMC/EMI tests ensure that the overall device is compatible with other medical devices and works optimally in the device environment when subjected to interference and immunity.

Conformance to this standard provides that medical equipment does not create electromagnetic fields that could impair the operation of other devices in the usual environment.

Chemical or biological testing help achieve device compatibility with the surface of the skin. Medical devices that contact skin must comply with the ISO 10993 series- Biological evaluation of medical devices.

For this, the manufacturer must consider the choice of material used compatibility between device materials and the biological tissues, cells, and body fluids. Testing methods like stress, shear testing, and ageing tests are performed so that the final product causes the least quality concerns.

Cybersecurity testing is crucial to medical devices so that risks such as unauthorised access to data and breaches are identified, and their occurrence minimised.

A common standard followed for medical device software is IEC 62304 and ISO27001. IEC 62304 standard specifies the life cycle requirements for medical device software, whereas in ISO 27001 focuses on data and information security.

It should be noted that each of the above standards is closely related to the ISO standard for risk management of medical devices (ISO 14971).

The risks associated with the medical device should be correctly identified, and appropriate tests should be done, proving that the relevant standards are met. Please read our article on global ISO requirements for a better understanding of the ISO standards. 

Testing requirements around the world

To fully comply with the regulations of each country, one must also align with the testing standards accepted within each country. ISO and IEC standards are accepted across the globe.

Compliance with these ensures that the devices can be marketed without any major difficulties. This article discusses the testing standards followed in major medical device markets.

In Europe, close to 80% of electrical and electronic standards follow the various IEC International Standards. Standards for electromedical equipment include IEC 60601 series standards for the requirements for high-frequency surgical instruments, short-wave therapy equipment and so on.

The EU from time to time releases the harmonized standards list which are the most acceptable standards for the EU compliance.

In the US, accepts certain ISO standards however there are a list of recognized consensus standards that the FDA accepts for medical devices in the US. These include ANSI, AAMI, ATSM and so on.

ANSI standards are applicable to a variety of industries like the ISO whereas AAMI testing standards are specific to medical instruments and ATSM standards are specific for materials used in medical devices.

Canada’s list of Recognized Standards for Medical Devices mentions a combination of ISO and ATSM standards. For electromedical compatibility, it accepts CSA standards.

Australia accepts the list of standards referenced in  Conformity Assessment Standard Orders (CASO) and Medical Device Standard Orders (MDSO). It is not mandatory but conformance to these standards are recommended.


Why are testing standards important?

Testing standards ensure that the medical device is fit for use not just for the patient but also for the healthcare professionals handling them. Most countries do not have stringent requirements for testing standards, but it is recommended that the devices have some form of tests done.

Why are risk management and testing standards closely linked?

Risk analysis is a crucial step in designing a medical device. Certain identified risks can be managed with a minor change in the initial stages of the manufacture and these can be identified with the help of an appropriate test.

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

CDSCO Registration Process

CDSCO Registration Process

This guidance is applicable to manufacturers placed within India. Get detailed information about CDSCO registration process.

Regulation Medical Devices Rules, 2017

Important Forms

License to manufacturer Notified Medical DevicesLicense in Form MD-5 or 6 for Class A or Class BApplication  form
Form MD-3 or 4  for Class A or Class B
Rule 20
Rule 20(4) and 20(6) for Class A or Class BState Drug Licensing Authority
License to manufacturer Notified Medical DevicesLicense in Form MD-9 or 10 for Class C or Class DApplication form
Form MD-7 or 8 for Class C or Class D
Rule 21
Rule 25(1) for Class C or Class D
Central Licensing Authority

Registration Process

Product Classification

Determine Product Classification as per India Medical Devices Rules, 2017 if they fall under the below as per Part I of first Schedule

  • Class A, B, C, D

Determine if the classified device falls under Notified Medical Devices or Non-Notified Medical Devices.

Quality Management System Certification

Establish and obtain a QMS certificate from a Notified Body (QMS defined in Fifth Schedule).

Perform Medical Device compliance testing as per BIS Standards. If no relevant BIS standard(s) are available, the manufacturer must choose to follow ISO/IEC standard compliance relevant to the medical devices

e-SUGAM Online Submission Requirements

The next significant step is to prepare the documents for the online submission as per Fourth Schedule Part I, II & III. The applicable documents are dependent on the class of device in the application.

  • Name and address of the company along with the address details of the site of manufacturing
  • Details of medical device:
Generic NameModel No.Intended UseClass of medical deviceMaterial of constructionDimensionShelf lifeSterile or Non-SterileBrand name if registered under the Trademarks act, 1999
  • ISO 13485 Certificate
  • Free Sale certificate from the country of Origin (not applicable for those manufactured within India)
  • Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic

Other required documents are listed at the end of this article

Online Registration Process

Steps to Start CDSCO License Application Process

It is required to appoint a competent technical staff who meets the competency listed in Rule 22(ii).

  1. Go to CDSCO home site >> Online System for medical devices
  2. Click on Login/Register to arrive at the Registration homepage
  3. Select from the Purpose >> For Manufacture of Medical Devices
  • Fill in the complete online application form
  • Upload all the documents as per in the checklist
  • Make the payment in the same portal (Link to Fee details are given at the end of this article)
  • Once the application is filled and complete, Click Submit
  • A confirmation email will be received to the registered email address
  • Track the application in the online portal

Timelines for Granting CDSCO Manufacturing License

For Class A

Within 45 days from the date of receipt of application the State Licensing Authority grants the license in Form MD-5 or Form MD-6 or rejects the application

For Class B

Within 90 days from the date of receipt of the application, the Notified body shall conduct an inspection of the manufacturing site

Within 30 days, the Notified body shall submit the audit report to the licensing authority

Within 20 days, the SLA scrutinises the documents, audit report and grant License in Form MD-5 or MD-6

For Class C or D

Within 45 days from the date of receipt of application, the CLA shall perform scrutiny of the application and technical documents using an expert

Within 60 days, a site inspection is carried out by the licensing authority comprising of experts (as mentioned in Rule 23) & the inspection report is sent copy to the applicant.

Within 45 days, the CLA scrutinises the documents, audit report and grant License in Form MD-9 or MD-10

Other Documents required for submission

  1. Power of Attorney (provided in MDR -Fourth Schedule, Part 1) To be authenticated in India either by a Magistrate of First Class or by the Indian Embassy in the country of origin or by an equivalent authority through apostille.
  2. Device description intended use of the device, specification including variants and accessories.
  3. Material of construction.
  4. Working principle and use of a novel technology (if any).
  5. Labels, package inserts (IFU, etc.,), user manual, wherever applicable
  6. Summary of any reported Serious Adverse Event in India or in any of the countries
  7. Site or plant master file as specified in Part III Appendix I of MDR
  8. Device Master File Part III Appendix II (Risk assessment
  9. Constitution details of the firm (of the domestic manufacturer or authorised agent)
  10. Essential principles checklist
  11. Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule
  12. Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years, if any.
  13. ISO 13485 Certificate
  14. Full Quality Assurance Certificate
  15. TR6 Challan (Service tax)
  16. Schedule D (1) (Drugs and Cosmetics Act)
  17. CE Design Certificate
  18. DoC
  19. Free Sale certificate
  20. Other Regulatory Approvals
  21. PMS report

Useful Links in the CDSCO portal

CDSCO Homepage


Checklist for Form MD-3, Form MD-7


Fees Payment Details

https://cdscomdonline.gov.in/NewMedDev/Homepage >> Scroll down to click on “Fee Payable” icon

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Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.