Definition of a Medical Device in Israel's Regulations

[zhang126]

Hi!

Can anyone help me with this and point out the legal source of the definition of medical device in Israel's regulation?

Thanks

Zhang

 

[somashekar]

Re: Definition of medical device in Israel's regulation

Hi!

Can anyone help me with this and point out the legal source of the definition of medical device in Israel's regulation?

Thanks

Zhang

• Medical Device/Medical Equipment:
− Instrument, device, software, chemical, biological or
biotechnological used in treatment or needed for the activation of a
device or apparatus that is used for treatment that is not MAINLY
intended to work on the body as a drug.


and I got this from Here

This may also be of interest to you ...


NOTE: Please see the most recent definition in the below posts...

 

[Ronen E]

Re: Definition of medical device in Israel's regulation

• Medical Device/Medical Equipment:
− Instrument, device, software, chemical, biological or
biotechnological used in treatment or needed for the activation of a
device or apparatus that is used for treatment that is not MAINLY
intended to work on the body as a drug.


and I got this from Here

This may also be of interest to you ...

Hmmm... not quite...

The definition, as finalised in the Medical Equipment Act 2012 (passed in parliament on 8.5.2012), is as follows (in a free translation from the Hebrew original):

Medical Equipment –
Any one of the following, excluding a preparation as defined in [the relevant legislation, related to pharmceuticals]:
(1) A device for medical treatment, and also a device or computer software required for operating such a device; for that matter, “a device” includes an accessory, a chemical substance, a biological product and a biotechnological product;
(2) Contact lenses;
(3) An electric device emitting an ionizing or non-ionizing radiation for cosmetic treatment.

I wouldn't rely on the Export.gov guidance from Y2000, because a lot has been going on in the field in Israel since that time; especially now with the new Act and associated regulations coming into effect.

Cheers,
Ronen.

PS The Act and regulations don't define "a medical device"; instead they refer to "medical equipment".

PS2 There is a transition period in place before the entire Act and associated regulations take effect.

 

[somashekar]

Re: Definition of medical device in Israel's regulation

This above from Ronan seems the latest from the Medical device law 2012, of 14 May 2012; volume 2357, 394 pages.

"Medical equipment" – Any of the hereunder detailed, excluding
preparation as defined in pharmacists act [new version], 1981 (*):

(1)Equipment used for medical treatment, and
equipment or computer software required to
operate such equipment; For this matter,
"equipment" – including accessory, chemical
material, biological product or biotechnology
product;
(2) Contact lenses;
(3) Electrical device emitting ionic or nonionic radiation
used for cosmetics treatment;

(*) State of Israel laws, new version 35, page 694

Above is an other English translation, translated from the Hebrew original by mind-farma.

 

[Ronen E]

Re: Definition of medical device in Israel's regulation

I think that there are some subtle issues with this last translation. I guess that the person responsible is either not very good with Hebrew, or not very good with English, or not too familiar with international medical devices regulation (or any combination)...

 

[MIREGMGR]

Re: Definition of medical device in Israel's regulation

PS2 There is a transition period in place before the entire Act and associated regulations take effect.

Any transition specifics available? Grandfathering plans? Recognition of other systems, i.e. FDA via a CTFG, CE Mark? Has the whole law been reliably translated somewhere?

 

[Ronen E]

Re: Definition of medical device in Israel's regulation

Any transition specifics available? Grandfathering plans? Recognition of other systems, i.e. FDA via a CTFG, CE Mark? Has the whole law been reliably translated somewhere?

Hi,

The entire Act comes into effect only after the associated regulations are issued. Most of the Act's clauses will come into effect 60 days after the regulations, but some only a year after the regulations (the Act specifies which are which). As of September 2012 the regulations haven't yet been finalised.

If by "Grandfathering" you mean that equipment cleared prior to the new Act taking effect will be automatically cleared under the new legislation as well, then the answer is yes, this is basically what's going to happen. Such automatic clearance will be in effect until that time that the original clearance was to expire, or until such clearance is actively cancelled earlier, under the new Act's provisions.

The Act includes a whole list of states, whose regulatory systems' clearance provide a similar clearance in Israel. In such cases the Israeli clearance would inherit all the conditions and limitations of the original clearance, including any expiry dates. The list includes the USA, various EC states, Australia & NZ and Canada.

The above is my own, non-official and non-binding reading of the Act. I am currently not aware of any official translation to English available online. The Act as published includes 16 pages. The latest draft I have of the upcoming regulations have a similar number of pages.

Cheers,
Ronen.

 

[zhang126]

Re: Definition of medical device in Israel's regulation

Thank you very much everyone above!

Could you please kindly provide a link to the original ACT in Hebrew?

 

[Ronen E]

Re: Definition of medical device in Israel's regulation

Thank you very much everyone above!

Could you please kindly provide a link to the original ACT in Hebrew?

Here's one in PDF format:

http :// www .justice. gov.il/NR/rdonlyres/2C9C041F-9887-4612-BCBB-1187FCEFEFAE/35345/2357.pdf - OBSOLETE BROKEN LINK UNLINKED

 

[somashekar]

Re: Definition of medical device in Israel's regulation

Here's one in PDF format:

The link shows only a section of it from page 394 to page 404 ...
Am I right ?