Medical Devices
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UMbet国际娱乐下载 has released the fifth draft of the UMbet国际娱乐下载 (UMbet国际娱乐下载 and UMbet国际娱乐下载) Rules (UMbet国际娱乐下载). The regulation will replace two existing rules – Manufacture, Storage and Import of Hazardous UMbet国际娱乐下载 Rules, 1989, and the UMbet国际娱乐下载 Accidents (Emergency Planning, Preparedness and Response) Rules, 1996. It is similar to EU UMbet国际娱乐下载 regulation and also known as 'UMbet国际娱乐下载 UMbet国际娱乐下载'. It is expected to be published in 2022.

The UMbet国际娱乐下载 will apply to all substances, substances in mixture, substance in articles and intermediates that are manufactured, imported, or placed in the UMbet国际娱乐下载n Territory exceeding 1 TPA. It requires manufacturers, importers or Authorized Representatives to notify new and existing substances and register substances that need registration.

Enterprises's Obligations - Notification

Notification is required for all substances exceeding 1 TPA. The substance will be notified for certain uses and downstream users need to notify the UMbet国际娱乐下载 Regulatory Division (CRD) if the intended use is not notified. UMbet国际娱乐下载 Regulatory Division will issue a certificate of Notification along with Notification Number once the notified substance is evaluated for its completeness. All New UMbet国际娱乐下载 UMbet国际娱乐下载s have to be notified at least 60 days prior to the date they are placed in UMbet国际娱乐下载n territory.

Data Requirements for Notification

  • Detailed information of the Notifier
  • UMbet国际娱乐下载 identification information
  • Impurities
  • UMbet国际娱乐下载 structural information and spectra
  • Hazard classification
  • Usage
  • Downstream user
  • Tonnage
  • Maximum storage capacity
  • SDS


Registration is required for identified substances that are listed in "Priority UMbet国际娱乐下载s Required to be Registered" in Schedule II of the UMbet国际娱乐下载 and with the tonnage exceeding 1 TPA. Currently, there are 750 substances listed in Schedule II and the list will be updated. Registration should be carried out within 18 months after a substance is included in Schedule II.

Technical dossier is required for registration. For substance exceeding 10 TPA, a UMbet国际娱乐下载 UMbet国际娱乐下载 Assessment is also required to be submitted along with Technical dossier. Registration fee will depend on tonnage band and company size.

The Intermediates listed in Schedule II with tonnage less than 1000 TPA should be registered with only the physical and chemical properties in the Technical Dossiers. Whereas Intermediates exceeding 1000 TPA should register with full information in the Technical Dossier along with the UMbet国际娱乐下载 UMbet国际娱乐下载 Report (CSR). Priority UMbet国际娱乐下载s intended to be or likely to be released from the article under normal or foreseeable conditions of use with the tonnage exceeding 1 TPA will also need to register.

Annual Report

Annual report is required for both Notification and Registration. The report should contain the quantity of substance placed in UMbet国际娱乐下载 Territory in the previous calendar year and changes to the information submitted at the time of notification/registration. The annual report should be completed before the 29th Feb. / 1st Mar of each calendar year.

Our Services

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  • Annual Report Preparation and Submission