A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

India Moves to Online Application Submission System for Medical Device Registration

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).

INDIAN GOVERNMENT REMINDS MEDICAL DEVICE INDUSTRY OF PENDING REGULATORY CHANGES

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.

Increase in Independent License Holder Option in India

More companies are setting up a subsidiary or using an independent license holder in order navigate the highly rationalized Indian market.

Indonesia Publishes Guidelines for Clinical Trail Approvals for Medical and Diagnostic Devices

Ablation Devices Now Require Registration in India

The India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.

Thailand to Implement New Medical Device Classification System

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.

INDIA APPLIES PRICE CONTROLS TO KNEE PROSTHESES

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).