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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.
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.
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 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
INDIA PLANS TO REGULATE ALL MEDICAL DEVICES
The CDSCO review process to generate a MD Form 15 typically takes 6 to 9 months with 6 to 8 weeks of application preparation. To be safe, manufacturers should begin the MD Form 15 application process 12 months before any deadline.
Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate and Import License.
KOREA CHANGES MEDICAL DEVICE QUALITY SYSTEM REQUIREMENTS
Any company applying for new or renewal KGMP certificates after July 1, 2019 will be subject to several new requirements. This change has the potential to add significant time and cost to the compliance requirements for manufacturers that employ multiple outsourced manufacturing facilities.
India to Regulate Surgical Drapes and Gowns
Surgical drapes and gowns have been added to the Indian list of notified medical devices. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.
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.