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India Medical Device Registration and Market Access

On October 14, 2022, the Indian Ministry of Health and Family Welfare issued final notification G.S.R. 777(E)formalizing the exemption of Class A non … See more

Actived: 7 days ago

URL: https://asiaactual.com/india/medical-device-registration/

Indonesia Ministry of Health (MoH)

WEBThe Indonesia Ministry of Health (MoH) functions as the country’s central regulatory body, overseeing the nation’s medical device industry. It is located in Jakarta. Prior to the …

Category: Medical Go Health

Vietnam Releases New Medical Device Regulations

WEBOn November 8 th, the Ministry of Health (MOH) officially released Decree 98/2021 ND-CP, which implements significant new changes to the rules governing …

Category: Health Go Health

Hong Kong Medical Device Registration and Listing Asia Actual

WEBHong Kong Regulatory Support. “Registering your medical device through the voluntary system is beneficial, because Hong Kong’s Hospital Authority gives preference to …

Category: Medical Go Health

Vietnam Ministry of Health (MoH)

WEBThe Vietnam Ministry of Health is the national regulatory body and competent authority in the country established in 1945. Its main offices are located in the capital city of Hanoi. …

Category: Health Go Health

New Procurement Strategy for Medical Devices in Hong Kong

WEBPublished on: June 14th, 2023. On June 5, 2023, the Hong Kong Department of Health (DH) formally published a new policy for the procurement of medical devices. Effective …

Category: Medical Go Health

Singapore Medical Device Registration and Approval

WEBRegistration fees in Singapore depend on the registration route which relies on the product’s approval history. Class A are free to list. Class B costs between US$635 …

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Thai FDA Announces New Application and Query Response …

WEBThai FDA Announces New Application and Query Response Timelines. On April 4, 2022, the TFDA updated their application query response policy aimed at …

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Indonesia Stops Government Purchases of 79 Imported Medical …

WEBPer Presidential Regulation 12/2021, the Ministry of Health (MOH) is requiring medical devices with a Domestic Component Level (TKDN) and Benefit Weigh Value …

Category: Medical Go Health

Vietnam Recent Adjustments to the Application Requirements

WEBPublished on: June 7th, 2023. Vietnam has recently made significant amendments to its medical device registration process and technical documentation requirements. The …

Category: Medical Go Health

Thailand Medical Device Registration and Approval Asia Actual

WEBGovernment Authority. Thailand’s medical device registration is managed by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration …

Category: Food, Medical Go Health

Philippines Medical Device Registration

WEBGovernment Authority. Medical device registration in the Philippines is managed by the Center for Device Regulation, Radiation Health and Research (CDRRHR) within the …

Category: Medical Go Health

Philippines Announces New PEMDL Essential Medical Device List

WEBNotification AO 2021-0038 was released on June 11 th, 2021 with the goal of creating a standardized system for determining and maintaining a database of essential …

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Medical Device Act

WEBTranslation Medical Device Act B.E. 2551 (2008)1 BHUMIBOL ADULYADEJ, REX; Given on the 26th Day of February B.E. 2551; Being the 63rd Year of the Present Reign. His …

Category: Medical Go Health

Philippines FDA Extends CMDN Deadline to 2024

WEBThe Center for Device Regulation, Radiation Health and Research ( CDRRHR) of the Philippines FDA has announced that the deadline for Certificate of …

Category: Health Go Health

Philippines IVD Device Registration Asia Actual, LLC

WEBOriginally released in February 2022, the draft IVD regulations outline the new requirements for registering all IVD products. Applications are first subject to pre-submission review at …

Category: Health Go Health

Notification of the Ministry of Public Health

WEBAnnounced on September 22, 2020 137 Special Section 260 D Government gazette 5 November 2020 Notification of the Ministry of Public Health Subject: Prescribing the …

Category: Health Go Health

OFFICE OFTHESECRETARY

WEBMark-up-refers to the amount added to a cost price in calculating a selling price, especially an amountthattakes into account overhead and profit. Medical Devices — refers toany …

Category: Medical Go Health