Mondaq Asia Pacific: Food, Drugs, Healthcare, Life Sciences
The changes will see current pathways for medical device registration remain, and three new pathways will also be added.
Kaden Boriss
The duty to take reasonable care to warn of risks does not extend to special steps to ensure the patient understands.
Kaden Boriss
The question of capacity arises when a patient refuses treatment that the practitioner considers is in his best interest.
Swaab Attorneys
Advanced Care Directives can be used to make decisions about your medical treatment when you lack capacity by yourself.
Jones Day
China has published various rules and policies promoting telemedicine services, and many businesses are interested in developing this market.
Ropes & Gray LLP
Additionally, it may be worthwhile to understand the level of compliance controls employed by the intermediary to assess third-party compliance risks.
Ropes & Gray LLP
China's recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable.
Jones Day
How the Opinions would be implemented is unclear and remains to be seen.
Ropes & Gray LLP
Unlike the DRR, the Revisions do not distinguish an international multicenter study from a drug registration study.
Ropes & Gray LLP
Ask a senior manager of a MedTech company in China what keeps her or him awake at night and "regulatory changes" will invariably be among the first things mentioned.
Foley & Lardner
These developments present significant opportunities for foreign health care providers and other investors.
Ropes & Gray LLP
The China Food and Drug Administration ("CFDA") recently proposed a draft circular to address the priority review designation issue for medical devices, namely the Circular Regarding Soliciting Comments Regarding Priority Review Designation Procedure for Medical Devices (CFDA Circular [2016] No.40, the "Circular").
Jones Day
Some pioneering industrial players have already made movements in this regard.
Ropes & Gray LLP
China's State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System ("MAH") for drugs in 10 provinces in China.
Khaitan & Co
FDCs are combinations of two or more active pharmaceutical ingredients in fixed ratios, given in the form of a single dose.
Kochhar & Co.
Food processing includes all the processes under filtration, manufacturing and preservation techniques undertaken for bringing value addition to the agricultural or horticultural produce.
S.S. Rana & Co. Advocates
CDSCO is the national regulatory authority in India that evaluates safety, efficacy and quality of drugs in the country.
Khaitan & Co
The Hon'ble Supreme Court of India has, in the case of State of Uttar Pradesh v Dr Dinesh Singh Chauhan, struck down the practice of grant of reservation for in-service candidates in post graduate medical degree courses.
Singh & Associates
The regulatory framework relating to clinical trial of drugs is governed under the Drugs and Cosmetics Act, 1940 ("Act") and the Drugs and Cosmetics Rules, 1945.
Singh & Associates
In an information release by Press Information Bureau on 14th May 2016, Ministry of AYUSH Government of India and the World Health organization (WHO) have signed an historic Project Collaboration Agreement (PCA) for cooperation on promoting the quality, safety and effectiveness of service provision in traditional and complementary medicine.
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