The Drugs Controller General of India (DCGI) announced on May 1, 2016 that the SUGAM online application submission system, in use since November 2015 for pharmaceutical registration, would be extended to medical device and IVD device submissions (e.g., registration and import license applications).
A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
Exactly 6 months before the new Medical Device Rules, 2017 are to take effect the Drugs Controller General (India), Dr. G.N. Singh, published a notice that serves as a reminder to industry to prepare for the coming changes.
More companies are setting up a subsidiary or using an independent license holder in order navigate the highly rationalized Indian market.
The India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.
The Thai Food and Drug Administration (FDA) has announced its intentions to implement a risk-based medical and IVD device classification system toward harmonization with ASEAN MDD guidelines.
Yesterday, India’s National Pharmaceutical Pricing Authority (NPPA) implemented price controls for knee prostheses resulting with an average reduction of 65% from prevailing market prices. The announcement was published on August 16, 2017, with immediate effect (full document available on the India page of Asia Actual’s website).