Posts

eRPS System: China National Medical Product Administration’s (NMPA) medical device registration system

Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.

Philippines Proposes New Fees for Medical Device Registration

The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D. 

CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION PROCESS

In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.

PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.

THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)

ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN

Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.

CHINA ENCOURAGES LOCAL MANUFACTURING OF FOREIGN MEDICAL DEVICES

China has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster. 

HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

Hong Kong’s Department of Health officially changed the name of the Medical Device Control Office (MDCO) to the Medical Device Division (MDD) at the end of 2019.