The Indian medical device industry has been recording significant growth and ranks in the top 20 markets for medical devices worldwide. It is estimated to reach USD 50 billion by 2025 from that of USD 10.36 billion in 2020. The Central Drug Standard Control Organization (CDSCO) regulates medical devices marketed in India and ensures to initiate and implement Regulatory frameworks for proper compliance of medical devices.
Ministry of Ecology and Environment (MEE) of China published the revised law for new chemical substances on May 7, 2020, which is said to be replacing the existing legislation, MEP Order 7, from Jan 1, 2021. The new update focuses on the major changes that MEE Order 12 has introduced and their implications for the industry from a legal standpoint. Let us have a brief look at it.
According to MEE Order 12, the following must submit notification: