Gunjan Verma- India

“Medical device manufacturers should act quickly to ensure compliance with the new regulations.”
Gunjan Verma
Asia Actual India 

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

India To Require Local Certification of All Power Cords

Initially published on: September 24, 2020

Updated on: October 22, 2020

UPDATE: The deadline for the registration of power cords has been postponed to October 23, 2021. 

Implementation of Bureau of Indian Standards (BIS) Mark of Conformity

Previously to be effective from December 1, 2020,  power cords, cord sets, plugs and sockets must carry the Mark of Conformity (product approval mark) which has been established by the Central Government of India through the Bureau of Indian Standards (BIS) Act (2016), BIS Rules 2018, and BIS Conformity Assessment Regulations (2018). The approval mark is codified as the “Plugs and Socket-Outlets and Alternating Current Direct Connected State Prepayment for Active Energy Order, 2019” (Quality Control Order attached).]

While there is some possibility for further delayed implementation, manufacturers should prepare accordingly. Industry groups have requested a delay until summer of 2021 due to the effects of COVID and required manufacturing changes, but no new guidance has been issued at this time.

Compliance Requirements

Under the new regulations, applicable products will need to obtain certification from a local BIS laboratory. There are currently 16 laboratories that can conduct IS1293 testing and 5 capable of certifying for IS15884. A database of BIS laboratories by standard can be found here. Local testing can take 2 to 3 months for typical fees of around US$1,200 to test 30 samples.

The following are the applicable BIS standards that apply to power cords. These standards are similar to IEC 60884-1 (2002), but with some modifications.

Good or Article StandardTitle of Indian Standards
Plugs and socket-outletsIS 1293:2005Plugs and socket-outlets of Rated Voltage up to and including 250 Volts and Rated current up to and including 16 amperes – specification
Alternating Current
Direct Connected
Static Prepayment
Meters for Active Energy
IS 15884:2010Alternating Current Direct Connected Static Prepayment Meters for Active Energy (Class1 and 2)- Specification

To avoid issues, manufacturers should check with suppliers to determine their products’ state of compliance and/or consider sourcing BIS certified power cords from India.

Asia Actual can provide the support required for local testing in India required for BIS certification. Please contact us with any questions or support requests.

Please contact Asia Actual with any questions or requests for support.

Blog Posts

Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices

Per Presidential Regulation 12/2021, the Ministry of Health (MOH) is requiring products with a Domestic Component Level (TKDN) and Benefit Weigh Value (BMP) of 40% or more be purchased by government hospitals regardless of available foreign products.

Philippines Announces New PEMDL Essential Medical Device List

Notification AO 2021-0038 was released on June 11th, 2021 with the goal of creating a standardized system for determining and maintaining a database of essential medical devices, hereby known as the Philippine Essential Medical Device List (PEMDL). Additionally, the Medical Devices and Supplies Price Reference Index (MDSPRI) will also be established to provide more price transparency when it comes to medical devices in the Philippines.

Russia and Euro-Asian Neighbors Expected to Transition to EAEU Regulations in 2022

With the release of Decree 142, the Russian government has provided a roadmap for their transition to the new EAEU medical device regulations beginning January 1, 2022. After this date, all applications submitted must adhere to the EAEU rules which can vary significantly from the current Russian requirements.