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).

Philippines Implements New Customs Clearance Procedure for Radiation Devices

Radiation-emitting medical devices such as X-ray machines, MRIs, linear accelerators and ultrasound scanners are now subject to a new customs clearance release procedure administered by the Philippine Food and Drug Administration (FDA)

Korea Announces Plans for Unique Device Identification (UDI) Requirements Starting in 2019

The Korean Ministry of Food and Drug Safety (MFDS) published a draft amendment to the Medical Device Act that mandates a new Management System for Controlling Medical Device Information (MCMI) to record information on the overall life cycle of the medical devices from manufacturing to end-use.

PHILIPPINES DELAYS LAUNCH OF NEW MEDICAL DEVICE REGULATIONS

The Philippines Food and Drug Administration (FDA) intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed.  Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.

INDIA MOVES QUICKLY TO REGULATE ORGAN PRESERVATION SOLUTION

This Notification announcement represents a departure from the anticipated process to add devices to those that require registration in India. Manufacturers of currently non-Notified devices should be vigilant about pending registration requirements.

INDONESIA E-CATALOGUE ENROLLMENT DEADLINE JUNE/JULY 2019

The Indonesian government procurement agency, known as LKPP, has invited medical device companies to apply for any existing e-Catalogue contract extensions by July of 2019

PHILIPPINES TO HOST ASEAN MEDICAL DEVICE COMMITTEE MEETING / TRAINING

The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.

INDONESIA CALLS FOR NEW ROUND OF E-CATALOGUE APPLICANTS

In response to the overwhelming interest to a June invitation for registered medical device license holder to request inclusion of their device/s in the 2019 e-Catalogue enrollment, the Indonesia Ministry of Health (MOH) has extended the application deadline.

INDIA COMPLIANCE MAINTENANCE: NOTIFIED BODY CHANGE

Given recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.