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

/in , /by

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

Read more

Ablation Devices Now Require Registration in India

/in , /by

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

Read more

New Office Space for Asia Actual India

/in , /by

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

Read more

Medical Device Pricing Controls May Be Coming to India

/in , /by

The National Pharmaceutical Pricing Authority (NPPA) in India is considering applying the Drug Price Control Order (DPCO) to medical devices. Importers of notified cardiovascular and orthopedic devices have been put on notice to control mark ups, or the NPPA will intercede. If so, limits will be applied to the difference between landed cost and the Maximum Retail Price (MRP) anticipated to be around 35%.

Read more

India Publishes New Medical Device Regulations

/in , /by

On July 12, the Ministry of Health and Family Welfare published a draft of new medical device regulations (Medical Device Rules, 2016) which will require registration for all medium to high risk medical and IVD devices. Implementation could happen as early as year end.

Read more

Comprehensive Medical Device Regulations Coming to India

/in , /by

The Indian Central Drugs Standard Control Organization (CDSCO) took another step closer to implementing comprehensive medical device regulations. On October 18th, a draft of the ‘Medical Device Rules, 2016’ was formally published for public comment. These Rules are similar to those informally circulated in July to industry stakeholders. A link to the document is available here on the Asia Actual website (the English version starts on page 145).

Read more

INDIAN GOVERNMENT REMINDS MEDICAL DEVICE INDUSTRY OF PENDING REGULATORY CHANGES

/in , /by

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.

Read more

INDIA APPLIES PRICE CONTROLS TO KNEE PROSTHESES

/in , /by

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).

Read more