A list of recently updated articles regarding medical device regulatory updates from the CDSCO and other governing bodies in India.

Increase in Independent License Holder Option in India

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

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Ablation Devices Now Require Registration in India

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

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New Office Space for Asia Actual India

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Asia Actual is excited to announce the dedication of our new office space in the Delhi area.  

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INDIAN GOVERNMENT REMINDS MEDICAL DEVICE INDUSTRY OF PENDING REGULATORY CHANGES

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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.

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INDIA APPLIES PRICE CONTROLS TO KNEE PROSTHESES

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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).

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New Regulations in India Raise the Bar for Many IVD Devices

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The new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications.

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