Tag Archive for: new requirements

Submission Changes in China: ToCs and the eRPS

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

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GUIDANCE ISSUED FOR IMPORTING UNREGISTERED MEDICAL DEVICES INTO KOREA

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Korea’s Ministry of Food and Drug Safety (MFDS) recently published final revisions regarding importing non-registered medical devices under special circumstances, including for research and personal use only, scarce or urgently needed, to be used by a Korean laboratory, clinical trials and/or orphan products.

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Singapore Releases New Guidance of Medical Device Software

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Singapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore.

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CHINA TAKES STEPS TO ENSURE QUALITY OF COVID-19 RELATED EXPORTS

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Chinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.

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Philippines Proposes New Fees for Medical Device Registration

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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. 

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

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

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CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION PROCESS

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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.

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THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

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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)

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ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN

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

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CHINA ENCOURAGES LOCAL MANUFACTURING OF FOREIGN MEDICAL DEVICES

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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. 

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