A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.
All IVD related equipment, instruments and software is now being transitioned to require registration in India under the Medical Device Rules, 2017, joining IVD reagents and kits which have been regulated since January 1, 2018, if not before.
All formerly unregulated medical devices are now being transitioned to require registration in India under the Medical Device Rules, 2017. These products should be Registered prior to October 1, 2021 and then obtain an Import License before October 1, 2022, or October 1, 2023 depending on the product’s risk classification.
With effect from December 1, 2020, India power cords, cord sets, plugs and sockets must carry the Mark of Conformity (product approval mark) which has been established by the Central Government of India through the Bureau of Indian Standards (BIS) Act (2016), BIS Rules 2018, and BIS Conformity Assessment Regulations (2018).
By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.
On July 1st, 2020 the Malaysia Medical Device Authority (MDA) will implement the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
In the wake of the COVID-19 outbreak, the Thai FDA announced on March 5, 2020 that they will cancel their plans to begin regulating alcohol gel sanitizers as medical devices.
The PCSO is a major source of funding for new hospital construction and medical device and equipment purchases and is often overlooked by outside suppliers. Medical device manufacturers should discuss with their Philippines distributors about what opportunities are available through the PCSO.
The Thai government has voiced their commitment to ending the epidemic by supporting preventative awareness, access to cost-effective tests and treatment resources through public investment and/or private partnerships.
実際の亞洲
เอเชีย แอคชวล
एशिया वास्तविक
실제 아시아
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
Contact Us
Privacy Policy
116 Changi Road, #04-05